Attachment A WIC Burden Narrative

Estimate of the Information Collection Burden for the Special Supplemental

Nutrition Program for Women, Infants and Children (OMB #0584-0043)

This document explains the calculation of the Information Collection Burden (ICB) for the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) under OMB #0584-0043, as revised to reflect adjustments and program changes. The resulting recalculations are highlighted below in bold, and are also reflected in the attached spreadsheet.

REPORTING REQUIREMENTS

AFFECTED PUBLIC: STATE AND LOCAL AGENCIES

(INCLUDING INDIAN TRIBAL ORGANIZATIONS AND US TERRITORIES)

1. Section 246.4 requires that by August 15 of each year, as a prerequisite for the receipt of

funds from the Food and Nutrition Service (FNS), the State agency must submit all substantive changes to its State Plan to FNS for approval. FNS estimates that each State agency needs 134.62 burden hours annually to update its State Plan. The total annual burden estimated for this provision was 12,116 burden hours (90 State agencies x 134.62 burden hours per year). This has not changed since the previous submission.

2. Section 246.5(b) requires each organization interested in being authorized as a local agency to submit an application to the State agency. The average local agency agreement is for two years; there are 1,837 local agencies; therefore, FNS estimates each year that half (918.5) of all local agencies submit applications. Each application requires two burden hours to complete. Thus, 918.5 local agencies x 2 burden hours per application = 1,837 annual burden hours for this provision. This represents a slight decrease of 2 hours since the last submission because the total number of local agencies decreased from 1,839 to 1,837. This decrease is due to a program adjustment.

2. Section 246.6 requires the State agency to enter into a signed agreement with each local agency, health and human service agency, and private physician that performs WIC functions. The average local agency agreement is for two years; therefore, FNS estimates each year that half of all local agencies (918.5) sign agreements with the State agency. Each agreement requires 1.5 burden hours to complete. Thus FNS estimates 1,378 annual burden hours for this provision (918.5 local agencies x 1.5 burden hours per agreement). This represents a slight decrease of 1.5 hours since the last submission because the total number of local agencies decreased. This decrease is due to a program adjustment.

2. Section 246.7(f)(2)(iii)(A) allows the State agency to extend the 10-day period of notification of eligibility for special nutritional risk applicants to 15 days when the local agency provides written justification of the need for such an extension. Currently, all State agencies have developed policies under which such an extension may be provided. FNS estimates that each year one-sixth or 306 of all local agencies make written requests for such extensions. Each request for an extension requires 0.25 burden hours to complete. FNS estimates 77 annual burden hours for this provision (306 local agencies x 0.25 burden hours per request). This represents a slight decrease of 0.13 hours since the last submission because the total number of local agencies has decreased. This decrease is due to a program adjustment.

2. Section 246.7(i) requires that pertinent certification data be collected and recorded by the local agency on a form (or forms) provided by the State agency (usually in the form of computer software) and that participants be notified of their rights and responsibilities, including notification of termination for failure to pick up food instruments, notification of disqualification and notification of expiration of each certification period. FNS estimates that the collection of certification data and the provision of appropriate notifications require ten minutes (0.17 burden hours) per participant.

FNS estimates 624,928 annual burden hours for the certification of women (1,838,023 women x 2 certifications/year = 3,676,046 total annual responses ÷ 1,837 = 2,001 certifications per local agency. 3,676,046 total annual responses x 0.17 burden hours per response = 624,928). This is a decrease of 88,009 hours for the certification of women due to a decrease in the number of women participants. This decrease is due to a program adjustment.

FNS estimates 1,015,270 annual burden hours for the certification of children (3,981,451 children x 1.5 certifications/year = 5,972,177 total annual responses ÷ 1,837 local agencies = 3,251 per local agency. 5,972,177 total annual responses x 0.17 burden hours per response = 1,015,270). This is an increase of 479,087 hours for the certification of children due to an increase in the number of child participants. This increase is due to a program adjustment. Although the burden reflects an increase in the total responses, FNS discovered errors in participation data submitted under the last burden revision and notes an actual decrease in the number of burden hours for the certification of children due to a decrease in the number of child participants.

FNS estimates 318,554 annual burden hours for the certification of infants (1,873,845 infants ÷ 1837 local agencies = 1,020 per local agency x 1837 local agencies = 1,873,845 x 0.17 burden hours per response = 318,554). This is a decrease of 490,822 hours for the certification of infants due to a decrease in the number of infant participants. This decrease is due to a program adjustment.

6. Section 246.7 (j)(9) requires that when the State agency must suspend or terminate the program benefits of any participant during the participant’s certification period due to shortages in program funds, the State agency must issue an advance notice to all affected participants. The State agency is also required to notify FNS prior to taking such action. FNS estimates that 4 State agencies may need to take such action per year. FNS further estimates that providing this notice to FNS would require 0.09 burden hours. Thus FNS estimates the total annual burden for this notice to FNS to be 0.36 burden hours (4 State agencies per year x 0.09 burden hours per notice). This has not changed since the last submission.

7. Section 246.7(k) requires the State agency to ensure that Verification of Certification

(VOC) cards are issued to participating migrants and to other participants who are likely to relocate during the certification period. Based on the number of participants with no priority reported, FNS estimates that 3% of participants receive VOC documentation. FNS further estimates that issuing VOCs requires 0.09 burden hours. FNS estimates the total annual burden for this provision to be 20,772 burden hours (7,693,319 participants x 0.03 participants receiving VOC documentation = 230,800 needing VOCs ÷ 1,837 local agencies = 126 participants provided VOCs per local agency x 1,837 local agencies = 230,800 responses x .09 burden hours = 20,772). This is a decrease of 3,422 hours to provide verification of certification due to a decrease in the number of participants. This decrease is due to a program adjustment.

8. Section 246.10(b)(1) requires State agencies to identify foods that are acceptable for use in the Program in accordance with program regulations.  This includes identifying which foods, substitutions, brands and packaging the State will authorize for use in the Program.  State agencies conduct such food reviews and submit food lists as part of their annual State Plan. FNS estimates that 40 burden hours are needed for each State agency to comply with this provision.  FNS estimates 3,600 total annual burden hours for this provision (90 State agencies x 40 burden hours per State agency). This has not changed since the last submission.

9. Section 246.10(b)(2) requires each State agency to identify the brands of foods and package sizes that are acceptable for use in the Program in their States. Each State agency must also include a list of acceptable foods and their maximum monthly allowances. In accordance with the implementation of the Electronic Benefits Transfer (EBT)-Related Provisions of Public Law 111-296 Final Rule on March 1, 2016, a State agency must now provide an updated Authorized Product List (APL) including a product’s Universal Product Code (UPC). Whereas, State agencies were initially required to provide an APL every 2.5 weeks, the requirement has been modified to allow a State agency to submit the APL files quarterly. Thus, FNS estimates an annual reporting burden of 1.79 hours. The time estimated for a State agency to compile and submit an APL is 30 seconds (0.0083 hours). A State agency will submit an APL 4 times per year x 54 State agencies (average per year) = 216 x .0083 = 1.79 hours.. The increase in 1.79 burden hours is associated with a program change as a result of the publication of the EBT final rule.

10. Section 246.10(d)(1) requires local agencies to obtain medical documentation in order to provide participants with infant formula not covered by the State agency’s infant formula rebate contract. FNS estimates that 1 percent (0.01) of all infant certifications require an additional two minutes (0.03 burden hours) for the documentation required to issue an infant formula that is not covered by the State agency’s infant formula rebate contract. Thus, FNS estimates 562 total annual burden hours for this provision (18,738 infants ÷ 1,837 local agencies = 10 infants per local agency x 1,837 local agencies = 18,738 infants x 0.03 burden hours = 562 burden hours). This is a decrease of 866 hours since the previous submission due to a decrease in the number of infant participants. This decrease is due to a program adjustment.

11. Section 246.11(d)(2) requires each local agency to develop and submit an annual nutrition education plan to the State agency. FNS estimates that 40 burden hours are needed for each local agency to comply with this provision. FNS estimates 73,480 total annual burden hours for this provision (1,837 local agencies x 40 burden hours per local agency = 73,480). This is a slight reduction of 80 hours since the last submission due to a slight decrease in the number of local agencies. This decrease is due to a program adjustment.

12. Section 246.12(g)(4)(i) requires a State agency to annually collect information needed to determine whether currently authorized and new vendor applicants derive or may be expected to derive more than 50 percent of their annual food sales revenue from WIC food instruments. Based on the Vendor Cost Containment (VCC) Final Rule, FNS estimates that each State agency will need 4 burden hours to collect the information required to assess a vendor’s status as an above-50-percent vendor.

FNS annually provides each State agency with a report comparing WIC redemptions to redemptions of the Supplemental Nutrition Assistance Program (SNAP) for each of its SNAP-authorized vendors; most WIC-authorized retail vendors are also SNAP-authorized. If a vendor’s SNAP redemptions exceed its WIC redemptions, the vendor is considered to be a regular vendor, not an above-50-percent vendor. The latest, The Integrity Profile (TIP) report shows that only 2,577 WIC authorized vendors have more WIC redemptions than SNAP redemptions. These are the only WIC authorized vendors from which WIC State agencies need to obtain further documentation.

Regarding the 2,577 authorized vendors whose above-50-percent status must be documented, there are about 29 such vendors per each State agency (2,576.7 authorized vendors ÷ 90 State agencies = 28.63 vendors per State agency). FNS estimates 10,308 burden hours for State agencies (90 x 28.63 vendors = 2,576.7, 2,577 x 4 hours = 10,308 for this provision. This is a slight decrease of 292 hours due to a decrease in the number of vendors whose WIC redemptions exceed their SNAP redemptions. This decrease is due to a program adjustment.

13. Section 246.12(g)(4)(ii)(B) requires State agencies to collect the shelf prices for WIC-approved foods from authorized retail vendors twice annually. Based on the VCC Final Rule, FNS estimates two hours per response for this provision. Approximately, 15 State agencies have been granted exemptions from collecting vendor shelf prices; 75 State agencies (90 State agencies – 15 State agencies = 75 State agencies) will each need to collect vendor shelf prices for 596 vendors biannually (44,724 / 75 State agencies = 596.32 vendors x 2 hours = 1,192.64 hours per State agency). FNS estimates 178,896 annual burden hours for this provision (75 State agencies x 1,192.64 hours per State agency = 89,448 total hours x 2 times per year). This is a slight decrease of 15,588 hours due to a decrease in the number of vendors. This decrease is due to a program adjustment.

As noted above, §246.12(g)(4)(ii)(B) states that FNS may grant State agencies exemptions from the requirement to collect shelf prices. Approximately 15 State agencies currently have exemptions; FNS also estimates that one State agency will request an exemption each year and that requesting an exemption under this provision will require16 burden hours per response. Thus FNS estimates 16 (1 x 16) annual burden hours for the exemption requests. This has not changed since the previous submission.

14. Section 246.12(i)(1) requires the State agency to conduct annual retail vendor training to assure that retail vendors have knowledge of program rules and procedures. FNS estimates that developing the content of retail vendor training materials requires 8 burden hours per State agency. FNS further estimates that it takes two burden hours to provide training to each vendor. FNS estimates 720 hours for developing the training (90 State agencies x 8 burden hours = 720). This has not changed since the last submission.

Additionally, FNS estimates 89,448 annual burden hours for conducting the training (44,724 vendors ÷ 90 State agencies = 497 responses per State agency. 90 State agencies x 497 = 44,724 responses x 2 burden hours = 89,448). There is a decrease of 7,794 hours since the previous submission due to a decrease in the number of vendors. This decrease is due to a program adjustment.

15. Section 246.12(j)(4) requires that each year the State agency conduct compliance investigations of five percent or 2,236 retail vendors. State agencies use a variety of resources to conduct compliance investigations, including State agency staff, contractor staff, local agency staff, law enforcement and staff of other WIC State agencies. For each compliance investigation, the State agency is required to conduct either two compliance buys or one inventory audit per retail vendor. FNS estimates that it takes one burden hour to conduct a compliance buy and two burden hours to conduct an inventory audit, which results in a total of two burden hours per compliance investigation (either 2 compliance buys x 1 burden hour or 1 inventory audit x 2 burden hours). FNS estimates 4,472 annual burden hours for this provision (44,724 retail vendors x .05 = 2,236 responses; 2,236 x 2 burden hours per compliance investigation = 4,472). This represents a decrease of 390 hours since the previous submission due to a slight decrease in the number of vendors. This decrease is due to a program adjustment.

16. Section 246.12(o) requires the State agency to develop and implement procedures to document the handling of complaints by participants and vendors. FNS estimates that 10,000 complaints are received a year from participants and vendors nationwide. FNS further estimates it takes one burden hour to process each complaint. The total annual burden estimated for this provision is 10,000 burden hours (10,000 complaints ÷ 90 State agencies = 111 complaints per State agency. 90 State agencies x 111 = 10,000 responses x 1 burden hour per complaint = 10,000). This has not changed since the last submission.

17. Section 246.12(q) requires the State agency to identify the disposition of all food instruments as either issued or voided and as either redeemed or unredeemed. Many State agencies currently track their food instrument inventories and disposition through their management information systems (MIS). The total annual burden estimated for this provision is 3,600 burden hours (90 State agencies x 40 burden hours). This has not changed since the last submission.

18. Section 246.14(d) requires the State agency to seek FNS approval of costs for automated data processing systems (ADP), capital expenditures over $25,000 and management studies performed by outside agencies, departments and consultants. FNS estimates that each year it receives an average of 15 requests for such approvals and that each request requires 160 burden hours for the State agency to document and submit. The total annual burden estimated for this provision is 2,400 annual burden hours (15 requests per year x 160 burden hours per request). In addition, FNS estimates that an additional 55 State agencies will seek approval each year during this reporting period due to the legislative mandate for statewide EBT by October 1, 2020. The total annual burden estimated for this provision increases from 2,400 annual burden hours (15 requests per year x 160 burden hours per request) to 11,200 annual burden hours (70 requests per year X 160 burden hours per request). This results in an increase of 8,800 hours as a program change since the last submission due to an increase in the number of State agencies that have transitioned to EBT.

19. Section 246.16(d) requires the State agency to allocate WIC funds to local agencies based on claims submitted at least quarterly by the local agency. FNS estimates that

State agencies distribute funds to 1,837 local agencies 4 times per year. Each distribution of funds requires two burden hours to complete. FNS estimates the total annual burden for this provision to be 14,696 annual burden hours (1,837 local agencies x 4 distributions per year ) / 90 State agencies = 81.64 distributions per State agency x 90 State agencies = 7,348 total distributions x 2 burden hours =14,696 annual burden hours). This results in a slight decrease of 16 hours since the last submission due to a decrease in the number of local agencies. This decrease is due to a program adjustment.

20. Section 246.17(c)(1) requires FNS to provide written notification of disqualification to all 90 State agencies that fail to comply with Program requirements. This provision also requires the State agency to provide written notification to local agencies that it determines have failed to comply with Program requirements.

FNS estimates that 10 local agencies will be disqualified per year. FNS further estimates that preparing and providing a written notice of disqualification requires 8 burden hours per notice. FNS estimates the total annual burden for this provision to be 80 burden hours (10 local agency disqualifications per year ÷ 90 State agencies = 0.11 response per State agency. Therefore, 90 State agencies x 0.11 = 10 responses x 8 burden hours per notice = 80). This has not changed since the previous submission.

21. Section 246.19(a)(2) requires the State agency to develop and submit a corrective action plan in response to an FNS management evaluation (ME) report. FNS’ goal is to conduct MEs on all functional areas of the program for all State agencies within a four-year cycle (0.25 x 90= 22.5 State agencies per year). FNS estimates that each corrective action plan takes approximately 40 burden hours to develop. FNS estimates 900 annual burden hours for this provision (0.25 x 90 = 22.5 State agencies x 40 burden hours per corrective action plan = 900). This has not changed since the previous submission.

22. Section 246.19(b)(5) requires the State agency to review target areas specified by

FNS during local agency reviews. Section 246.19(b)(3) requires the State agency to conduct monitoring reviews of each local agency at least once every two years, which means that each year half (0.5) of all local agencies will be reviewed. FNS estimates that the State agency will be required to address targeted areas during local agency reviews once every four years (0.25). FNS further estimates that it takes two burden hours for the State agency to address targeted areas during local agency reviews and report the results of the targeted reviews to FNS. FNS estimates 460 total annual burden hours for this provision (1,837 local agencies ÷ 90 State agencies = 20 local agencies x 0.5 local agencies to be reviewed = 10 local agencies per State agency to be reviewed x 0.25 every four years = 2.5 Local agencies to be reviewed in targeted areas, 2.5 local agencies to be reviewed in targeted areas x 90 State agencies = 229.63 total local agencies to be reviewed in targeted areas x 2 burden hours = 459 annual burden hours). This is a slight reduction of .50 hours since the last submission due to a slight decrease in the number of local agencies. This decrease is due to a program adjustment.

23. Section 246.20(a)(2) requires the State agency to develop and submit a corrective action plan to FNS addressing the findings of USDA Office of the Inspector General (OIG) State or local agency audits. FNS estimates that OIG performs one audit of WIC State and local agencies each year. FNS further estimates that each audit response requires 40 burden hours to complete. Thus FNS estimates the total annual burden for this provision to be 40 burden hours (1 audit per year x 40 burden hours per audit response). This results in a decrease of 120 hours since the last submission due to a revised estimate on the number of audits to be performed each year. This decrease is due to a program adjustment.

AFFECTED PUBLIC: INDIVIDUALS & HOUSEHOLDS:

APPLICANTS FOR PROGRAM BENEFITS

1. Sections 246.7(i) requires that certification data be collected from all participants and recorded by the local agency on a form(s) provided by the State agency (usually in the management information system (MIS)). WIC Program regulations permit local agencies to accept an applicant’s documented participation in certain other means-tested programs as evidence of income eligibility for the WIC Program. This provision helps to reduce the administrative burden on WIC local agency staff and eliminates duplication for program applicants. The income eligibility is established by applicants providing written documentation to the local agency either in the form of a benefit letter, identification card or in the form of an MIS check. Applicants or certain family members that receive Medicaid, SNAP, TANF or State-administered programs with income criteria at or below 185 % of the federal poverty guidelines are not subject to the standard WIC income eligibility determination. Though some information is collected for the entire household, some documentation (such as identification) is required for each WIC applicant. Additionally, infants less than six months of age may be certified through the month of their first birthday and children may be certified for one year.

FNS estimates that providing certification data to the local agency requires three minutes (0.05 burden hours) on average per participant.

Monthly WIC participation is 7,693,319 (1,838,023 women, 1,873,845 infants and 3,981,451 children).

• Women are certified twice per year, thus FNS estimates 183,802 hours for this provision (1,838,023 participants x 2 times per year = 3,676,046 x .05 burden hours per response). This results in a decrease of 25,885 hours since the previous submission due to a decrease in the number of women participants. This decrease is due to a program adjustment.

• Infants are certified once per year, thus FNS estimates 93,692 hours for this provision (1,873,845 participants x 1 time per year = 1,873,845 x .05 burden hours per response). This results in a decrease of 144,359 hours since the previous submission due to a decrease in the number of infant participants. This decrease is due to a program adjustment.

• Children may be certified once or twice per year. More than half of WIC State agencies certify children once per year. FNS estimates 298,609 hours for this provision (3,981,451 participants x 1.5 times per year = 5,972,177 x .05 burden hours per response). This results in an increase of 140,908 hours since the previous submission due to an increase in the number of child participants. This increase is due to a program adjustment. Although the burden reflects an increase in the total responses, FNS discovered errors in participation data submitted under the last burden revision and notes an actual decrease in the number of burden hours for the certification of children due to a decrease in the number of child participants.

2. Section 246.10(d)(1) requires that medical documentation must be obtained from the parents or guardians of infant participants in order for the Program to provide these infants participants with infant formula not covered by the State agency’s infant formula rebate contract. FNS estimates that one percent (0.01) of all infant certifications require an additional two minutes (0.03 burden hours) for the documentation required to issue an infant formula that is not covered by the State agency’s infant formula rebate contract. FNS estimates 562 hours for this provision (18,738 infants x .03 annual burden per response). This results in a decrease of 866 hours since the previous submission due to a decrease in the number of infant participants. This decrease is due to a program adjustment.

This section also requires additional medical documentation for the issuance of the following supplemental foods: (ii) Any infant formula prescribed to a child or adult who receives Food Package III; (iii) Any exempt infant formula; (iv) Any WIC-eligible medical food; (v) Any authorized supplemental food issued to participants who receive Food Package III. FNS estimates that it takes an additional three minutes (.05 burden hours) for the documentation required for the issuance of these foods.

FNS estimates that approximately one percent of participants (7,693,319 participants x .01 = 76,933) will be issued supplemental foods under Food Package III; one percent of children (3,981,451 children x .01 = 39,815) will be authorized soy-based beverage or tofu under Food Package IV; and, one percent of women (1,838,023 women x .01 = 18,380) will be authorized tofu and cheese in excess of the maximum substitution rate under Food Packages V and VII. Thus, FNS estimates 13,513 annual burden hours for this provision ((76,933.19 participants + 39,184.51 children + 18,380.23 women = 135.128 participants x .05 x 2 times per year). This is an increase in 4,552 hours since the last submission due to an increase in women and infant participation. This increase is due to a program adjustment.

AFFECTED PUBLIC: BUSINESS: RETAIL VENDORS

(WIC-AUTHORIZED RETAIL VENDORS)

1. Section 246.12(g)(4)(i) requires State agencies to collect information needed to determine whether currently authorized vendors and new vendor applicants derive or may be expected to derive more than 50 percent of their annual food sales revenue from WIC food instruments. FNS estimates two vendor burden hours per response for this requirement.

FNS annually provides each State agency with a report comparing the WIC redemptions to the redemptions of the Supplemental Nutrition Assistance Program (SNAP) for each of its vendors which is authorized by SNAP. If a vendor’s SNAP redemptions exceed its WIC redemptions, that vendor is considered to be a regular vendor, not an above-50-percent vendor. The most recent report shows that only 2,577 WIC authorized vendors have more WIC redemptions than SNAP redemptions. These are the only WIC authorized vendors from which WIC State agencies need to obtain further documentation.

FNS estimates 5,154 burden hours for vendors for this provision (2,577 vendors x 2 hours). This results in a slight decrease of 146 hours due to a decrease in the number of vendors whose WIC redemptions exceed their SNAP redemptions. This decrease is due to a program adjustment.

2. Section 246.12(g)(4)(ii)(B) requires State agencies to collect the shelf prices for WIC-approved foods from authorized retail vendors twice annually unless they have received an exemption from this provision from FNS. FNS estimates that 75 WIC State agencies must collect shelf prices from vendors. FNS estimates that twice annually each vendor would need one burden hour to report shelf prices.

FNS estimates 149,080 annual burden hours for this provision (44,724 vendors x (75/90) State agencies = 37,270 x 2 times per year = 74,540 x 2 burden hours per response). This results in a decrease of 12,990 hours since the previous submission due to a decrease in the number of vendors. This decrease is due to a program adjustment.

3. Section 246.12(h) requires the State agency to enter into written agreements with retail vendors. State agencies require the vendor to submit a signed vendor agreement with the completed application form. The average retail vendor agreement is for two years; therefore, FNS estimates that each year half (0.5) of all retail vendors will submit application/agreement forms. FNS further estimates that each application/agreement form requires 1 burden hour for the vendor to complete. Thus FNS estimates 22,362 burden hours for this provision for vendors (44,724 retail vendors x 0.5 of all retail vendors per year = 22,362 x 1 per year = 22,362 x 1 burden hour per application = 22,362 annual burden hours). This results in a decrease of 1,949 hours since the previous submission due to a decrease in the number of vendors. This decrease is due to a program adjustment.

4. Section 246.12(h)(8)(i) requires above-50-percent vendors to request approval from their WIC State agencies for incentive items which these vendors may provide to WIC participants or other customers. There are currently 2,577 above-50-percent vendors authorized by 12 WIC State agencies. Of these 12 State agencies, 4 allow above-50-percent vendors to give incentive items and will collect this information. FNS estimates that this reporting burden will involve 1 hour per response. Thus, FNS estimates an annual reporting burden of 859 hours for vendors as a result of this provision (2,577 vendors x (4 above-50-percent vendors / 12 State agencies) x 1 burden hour per response = 859 annual burden hours). This results in an increase of 553 hours since the previous submission due to an increase in the number of above-50-percent vendors. This increase is due to a program adjustment.

RECORDKEEPING REQUIREMENTS

AFFECTED PUBLIC: STATE AND LOCAL AGENCIES

(INCLUDING INDIAN TRIBAL ORGANIZATIONS AND US TERRITORIES)

1. Section 246.10(d)(1) requires medical documentation for the issuance of the following supplemental foods: (ii) Any infant formula prescribed to a child or adult who receives Food Package III; (iii) Any exempt infant formula; (iv) Any WIC-eligible medical food; (v) Any authorized supplemental food issued to participants who receive Food Package III. FNS estimates that it will take one minute (0.016 per record) for each clinic (10,000 clinics) to file the medical documentation provided by participants, for an estimated annual burden of 320 hours (10,000 clinics x 2 times per year x 0.016 burden hours per clinic). This has not changed since the last submission.

2. Section 246.12(g)(10) requires WIC State agencies to annually provide authorized WIC retail vendors a list of State-licensed infant formula wholesalers, distributors and retailers, and FDA-registered infant formula manufacturers. FNS has provided the list of FDA-registered manufacturers to State agencies. A State agency would contact the licensing agency in its State to obtain a list of the other suppliers. A State agency could satisfy this requirement by linking its web site to the list of licensed suppliers on the web site of the State’s licensing agency. The total annual burden hours for the list requirement is estimated at 4,500 (90 State agencies x 50 burden hours per response = 4,500 total annual burden hours). This has not changed since the last submission.

3. Section 246.12(h)(1)(i) requires the State agency to enter into written agreements with retail vendors. State agencies require the vendor to submit a signed vendor agreement with the completed application form. The average retail vendor agreement is for two years; therefore, FNS estimates that half of all retail vendors will submit applications each year. FNS further estimates that each application requires one burden hour to collect and record in the State agency’s recordkeeping system; most State agencies use an electronic MIS for this purpose. FNS estimates 22,362 annual burden hours for this provision for State agencies (22,362 retail vendors x 1 burden hour per application/agreement). This results in a decrease of 1,949 hours since the previous submission due to the decrease in the number of vendors. This decrease is due to a program adjustment.

4. Section 246.12(h)(8)(i) requires WIC State agencies to establish a process for approving incentive items that above-50-percent vendors may provide to WIC participants or other customers. There are currently 2,577 above-50-percent vendors authorized by 12 WIC State agencies. Of these 12 State agencies, only 4 allow above-50-percent vendors to give incentive items and will collect this information. FNS estimates that this reporting burden will involve one hour per response. Thus, FNS estimates an annual recordkeeping burden of 859 hours as a result of this provision (2,577 vendors x (4 above-50-percent vendors / 12 State agencies) x 1 burden hour per response = 859 annual burden hours). This results in an increase of 553 hours since the previous submission due to an increase in the number of above-50-percent vendors. This increase is due to a program adjustment.

5. Section 246.12(i)(4) requires the State agency to document the content of its vendor training and the participation of its vendors in the training. FNS estimates that documenting the content of and participation in vendor training takes the State agency two burden hours per year. FNS estimates 180 annual burden hours for this provision (90 State agencies x 2 burden hours per year). This has not changed since the last submission.

6. Section 246.12(j)(6) requires the State agency to document the routine monitoring visits it conducts on its vendors. Section 246.12(j)(2) requires the State agency to conduct routine monitoring visits of five percent (0.05) of its vendors each year. FNS estimates that each routine monitoring visit takes one burden hour to document. FNS estimates 2,236 annual burden hours for this provision (44,724 vendors ÷ 90 State agencies = 497 x 0.05 = 25 annual routine monitoring requirement per State agency x 90 State agencies = 2,236 x 1 burden hour per visit = 2,236 annual burden hours). This results in a decrease of 195 hours since the previous submission due to a decrease in the number of vendors. This decrease is due to a program adjustment.

7. Section 246.12(j)(6)(ii) requires the State agency to document the compliance investigations it conducts on its vendors. Section 246.12(j)(4) requires the State agency to conduct compliance investigations of five percent (0.05) of its vendors each year. For each compliance investigation, the State agency is required to conduct either two compliance buys or one inventory audit per vendor. FNS estimates that it takes one burden hour to document a compliance buy and two burden hours to document an inventory audit, which results in two burden hours per compliance investigation (either 2 compliance buys x 1 burden hour, or 1 inventory audit x 2 burden hours). FNS estimates 4,472 annual burden hours for this provision (44,724 vendors ÷ 90 = 497 x 0.05 = 25 annual routine monitoring requirement per State agency x 90 State agencies = 2,236 x 2 burden hours = 4,472 annual burden hours). This results in a decrease of 390 hours since the previous submission due to a decrease in the number of vendors. This decrease is due to a program adjustment.

8. Section 246.12(l)(3) requires the State agency to notify a vendor in writing when an investigation reveals an initial violation for which a pattern of violations must be established in order to impose a sanction before another violation is documented, unless the State agency determines notifying the vendor would compromise an investigation. Prior to imposing a sanction for a pattern of violations, a State agency would either provide a notice to the vendor or document in the vendor file the reason(s) that such notice would compromise an investigation. Approximately, 2,300 vendors investigated annually commit violations involving a pattern. FNS estimates one burden hour per response for this activity, for an annual total for all 90 State agencies of 2,300 burden hours (2,300 vendors / 90 State agencies = 25.56 vendors per State agency x 90 State agencies = 2,300.4 x 1 burden hour per notice action = 2,300 annual burden hours). This has not changed since the last submission.

9. Section 246.23(c)(1) requires the State agency to maintain documentation on file regarding the disposition of cases involving improperly obtained or improperly disposed of benefits that result from participant violations. FNS estimates that this recordkeeping requirement takes the State agency five burden hours per year. FNS estimates 450 annual burden hours for this provision (90 State agencies x 5 burden hours per year). This has not changed since the last submission.

10. Section 246.25(a) requires both the State and local agency to maintain full and complete records regarding financial operations and food delivery systems. However, such recordkeeping actually occurs at the State agency level because of the use of centralized MIS systems. FNS estimates that this recordkeeping requirement takes the State or local agency two burden hours per month. FNS estimates 46,248 total annual burden hours for this provision (90 State agencies + 1,837 local agencies = 1,927 x 2 burden hours per month x 12 months per year). This results in a decrease of 48 hours due to a program adjustment and decrease in the number of local agencies.

11. Section 246.25(a) requires the State and local agency to maintain full and complete records regarding nutrition education. The local agency enters the data into a system hosted at the State agency level. FNS currently estimates annual participation of women and children is 5,819,474 (1,838,023 women + 3,981,451 children) and participation of infants is 1,873,845. FNS further estimates that documenting nutrition education contacts takes one minute (0.017 burden hours) per participant. Participants should receive nutrition education four times per year. FNS estimates 395,724 annual burden hours for women and children (5,819,474 women and children x 4 times per year = 23,277,896 x 0.017 burden hours = 395,724 annual burden hours). This burden has increased by 110,155 hours since the previous submission due to an increase in child participants. This increase is due to a program adjustment. Although the burden reflects an increase in the total responses, FNS discovered errors in participation data submitted under the last burden revision and notes an actual decrease in the number of burden hours for the certification of children due to a decrease in the number of child participants.

FNS estimates 127,421 annual burden hours for infants (1,873,845 infants x 4 times per year = 7,495,380 x 0.017 burden hours = 127,421 annual burden hours). This results in a decrease of 196,329 hours since the previous submission due to the number of infants decreasing. This decrease is due to a program adjustment.

12. Section 246.25(a) requires the State and local agency to maintain full and complete records regarding fair hearing procedures. Such recordkeeping actually occurs at the State agency level because most fair hearings are conducted at the State agency level. FNS estimates that documentation of the fair hearing procedures takes 0.25 burden hours per State or local agency. FNS estimates 482 annual burden hours for this provision (1,837 local agencies + 90 State agencies = 1,927 x 0.25 burden hours per State or local agency). This results in a decrease of .5 burden hours since the previous submission due to the number local agencies decreasing. This decrease is due to a program adjustment.