SUPPORTING STATEMENT
1. Circumstances
Making the Collection of Information Necessary
Statutory
requirements for infant formula under the Federal Food, Drug, and
Cosmetic Act (the act) are intended to protect the health of infants
and include a number of reporting and recordkeeping requirements.
Among other things, section 412 of the act (21 U.S.C. 350a) requires
manufacturers of infant formula to establish and adhere to quality
control procedures, notify FDA when a batch of infant formula that
has left the manufacturers' control may be adulterated or misbranded,
and keep records of distribution. FDA has issued regulations to
implement the act's requirements for infant formula in parts 106 and
107 (21 CFR parts 106 and 107). FDA also regulates the labeling of
infant formula under the authority of section 403 of the act (21
U.S.C. 343). Under the labeling regulations for infant formula in
part 107, the label of an infant formula must include nutrient
information and directions for use. The purpose of these labeling
requirements is to ensure that consumers have the information they
need to prepare and use infant formula appropriately. In a notice of
proposed rulemaking published in the Federal Register of July 9, 1996
(61 FR 36154), FDA proposed changes in the infant formula
regulations, including some of those listed in tables 1, 2, and 3 of
this document. The document included revised burden estimates for the
proposed changes and solicited public comment. In the interim,
however, FDA is seeking an extension of OMB approval for the current
regulations so that it can continue to collect information while the
proposal is pending.
FDA requests extension of OMB approval for the information collections requirements contained in the following citations:
Section 412(d) of the Federal Food, Drug, and Cosmetic Act - Reporting
Requires submission to the agency of information specified in section 412(d) of the act. This includes, under section 412(d)(1) a quantitative formulation of the infant formula, a description of any reformulation or change in processing, assurances that the formula will not be marketed until it meets the requirements of subsection (b)(1) and (I) as demonstrated by testing required under subsection (b)(3), and assurances that the processing complies with subsection (b)(2). In addition, under section 412(d)(2), after the first production of an infant formula, a written verification is required which demonstrates that the formula complies with requirements of subsections (b)(1), (b)(2)(A), (b)(2)(B)(I), (b)(2)(B)(iii), (b)(3)(A), (b)(3)(C), and (I). Furthermore, under section 412(d)(3), if the manufacturer of an infant formula determines that a change in formulation or processing of the formula may affect whether the formula is adulterated under subsection (a), the manufacturer shall, before the first processing of the infant formula, make the submission to the Secretary required by section 412(d)(1).
21 CFR 106.100 - Record keeping
Requires maintenance and retention of records associated with microbiological/nutrient testing, quality control procedures, audits and investigation of consumer complaints.
21 CFR 106.120(b) - Reporting
Requires notification to the Agency when there is an infant formula that is adulterated or misbranded that may pose a risk to human health.
21 CFR 107.10(a) - Disclosure - Labeling
Requirement for specific nutrient information to be displayed on infant formula labeling.
21 CFR 107.20 - Disclosure - Labeling
Requirement for specific directions for use to be displayed on infant formula labeling.
21 CFR 107.50(e)(2) - Reporting
Requires notification to the Agency when there is an exempt infant formula that is adulterated or misbranded that may present risk to human health.
21 CFR 107.50(b)(3) - Reporting
Requirement for labeling to maintain exempt status of infant formula.
21 CFR 107.50(b)(4) - Reporting
Requirement for reformulation information when there is a change in ingredients or processes in order to maintain exempt status of infant formula.
21 CFR 107.50(c)(3) - Record keeping
Requirement for manufacturer to maintain records of its quality control procedures. (Regulatory language; burden in 21 CFR 106.100).
2. Purpose
and Use of the Information Collection
This
information is used by consumers when purchasing, storing and
preparing infant formulas. The information is also used by firms
and FDA to confirm that the nutrient requirements of the IFA have
been met.
Description
of Respondents: Respondents
to this information collection are manufacturers of infant formula.
Respondents are from the private sector (for-profit businesses).
3. Use
of Improved Information Technology and Burden Reduction
Through
the use of improved information technology the agency is always
seeking ways to reduce the burden of maintaining quality control
procedures and labeling requirements for infant formulas.
Manufacturers of infant formula may submit infant formula
notifications in electronic format. FDA estimates that all of the
respondents (100%) will use electronic means to submit the required
information.
4. Efforts
to Identify Duplication and Use of Similar Information
There
is no duplicative information collection as a result of the infant
formula regulations. The data recorded are specific to the
individual processing facilities. No other regulation or
information collection duplicates this effort. There are no similar
data that can be used or modified for use.
5. Impact on Small
Businesses or Other Small Entities
None
of the manufacturers of infant formula (0%) fit the definition of
small business. The regulations provide flexibility to
manufacturers to verify nutrient levels by either testing during
production or after processing. This provides the necessary
flexibility to accommodate the various manufacturing methods and
capabilities of both large and small manufacturers. FDA aids small
businesses in dealing with the requirements through the Division of
Education and Communication in the Center for Food Safety and
Applied Nutrition (CFSAN) and through the scientific and
administrative staffs of the agency.
6. Consequences
of Collecting the Information Less Frequently
Respondents
will submit the required information on an occasional basis, as
required by the regulations. The need for confirming nutrient
levels of each batch of infant formula has been demonstrated each
time a nutrient deficiency or overage has occurred since the passage
of the IFA. These deficiencies or overages could have resulted in
infant illnesses if the problem had gone undetected. However, due
to the required testing by the manufacturers, discrepancies in
nutrient levels have been found quickly and no illnesses have been
reported to FDA resulting from inappropriate nutrient levels found
in infant formulas since passage of the IFA.
7. Special
Circumstances
Relating to the
Guidelines of 5 CFR 1320.5
There
are no special circumstances associated with this collection of
information.
8. Comments
in Response to the Federal Register Notice and Efforts to Consult
Outside the Agency
In
accordance with 5 CFR 1320.8(d), in the Federal Register of May 4,
2010 (75 FR 23777), FDA published a 60-day notice requesting public
comment on the information collection provisions. FDA received no
comments.
12. Estimates
of Annualized Burden Hours and Costs
12
a. Annualized Hour Burden Estimate
FDA estimates the burden of this collection of information as follows:
Table 1.--Estimated Annual Reporting Burden1 |
|||||||
Federal Food, Drug, and Cosmetic Act or 21 CFR Section |
No. of Respondents |
Annual Frequency per Response |
Total Annual Responses |
Hours per Response |
Total Hours |
|
|
Section 412(d) of the act |
5 |
13 |
65 |
10 |
650 |
|
|
21 CFR 106.120(b) |
1 |
1 |
1 |
4 |
4 |
|
|
21 CFR 107.50(b)(3) and (b)(4) |
3 |
2 |
6 |
4 |
24 |
|
|
21 CFR 107.50(e)(2) |
1 |
1 |
1 |
4 |
4 |
|
|
Total |
|
|
|
|
682 |
|
|
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden1 |
|||||||
21 CFR Section |
No. of Record-keepers |
Annual Frequency per Record-keeping |
Total Annual Records |
Hours per Record |
Total Hours |
|
|
106.100 |
5 |
10 |
50 |
400 |
20,000 |
|
|
107.50 (c)(3) |
3 |
10 |
30 |
300 |
9,000 |
|
|
Total |
|
|
|
|
29,000 |
|
|
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 3.--Estimated Annual Third Party Disclosure Burden1 |
|||||||
21 CFR Section |
No. of Respondents |
Annual Frequency of Disclosure |
Total Annual Disclosures |
Hours per Disclosure |
Total Hours |
|
|
21 CFR 107.10(a) and 107.20 |
5 |
13 |
65 |
8 |
520 |
|
|
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
In compiling these estimates, FDA consulted its records of the number of infant formula submissions received in the past. All infant formula submissions to FDA may be provided in electronic format. The hours per response reporting estimates are based on FDA’s experience with similar programs and information received from industry.
FDA estimates that it will receive 13 reports from 5 manufacturers annually under section 412(d) of the act, for a total annual response of 65 reports. Each report is estimated to take 10 hours per response for a total of 650 hours. FDA also estimates that it will receive one notification under § 106.120(b). The notification is expected to take four hours per response, for a total of four hours.
For exempt infant formula, FDA estimates that it will receive 2 reports from 3 manufacturers annually under §§ 107.50(b)(3) and (b)(4), for a total annual response of 6 reports. Each report is estimated to take 4 hours per response for a total of 24 hours. FDA also estimates that it will receive one notification under § 107.50(e)(2). The notification is expected to take four hours per response, for a total of four hours.
FDA estimates that 5 firms will expend approximately 20,000 hours per year to fully satisfy the record keeping requirements in § 106.100. It is estimated that 3 firms will expend approximately 9,000 hours per year to fully satisfy the record keeping requirements in § 107.50(c)(3).
FDA estimates that compliance with the labeling requirements of §§ 107.10(a) and 107.20 will require 520 hours annually by 5 manufacturers.
12 b. Annualized Cost Burden Estimate
There are 5 firms marketing infant formula and exempt infant formula in the United States. FDA estimates that the average hourly wage for respondents is equivalent to a GS-9-5 level in the locality pay area of Washington-Baltimore in 2010, $28.04/hour. Doubling this wage to account for overhead costs, FDA estimates the average hourly cost to respondents to be $56.08/hour. The overall estimated cost incurred by the respondents is $$1,693,728.10 (30,202 burden hours X $56.08/hr = $1,693,728.10).
13. Estimates of Other
Total Annual Costs to Respondents and/or Recordkeepers/Capital
Costs
There are no capital,
start-up, operating, or maintenance costs associated
with this collection.
14. Annualized
Cost to the
Federal Government
FDA
consumer safety officers review submitted notifications with input
from technical reviewers. The dollar estimate for FDA consumer
safety officer wages corresponds roughly to GS level 13, step 6,
which is $95,459 annually per the 2010 GS Salary Table. These costs
are estimated at 3.3 person years (PY) or an approximate total of
$315,014.70 ($95,459 X 3.3 PY = $315,014.70).
FDA
investigators currently inspect each manufacturing site annually and
collect product labels for review. The dollar estimate for FDA
investigator wages corresponds roughly to GS level 12, step 3, which
is $73,396 annually per the 2010 GS Salary Table. It is estimated
that the agency expends approximately 1.3 PY on each firm for a
total of 5.2 PY (1.3 PY X 4 = 5.2 PY) on enforcement activities
associated with violations of these regulations. The costs are
estimated at a total of $381,592 ($73,396 X 5.2 PY = $381,592).
Thus, the total cost to the Federal Government is $696,673.90.
15. Explanation
for Program Changes or Adjustments
There
is no change in burden from that previously approved.
16. Plans for Tabulation and Publication and Project Time Schedule
The
agency has no plans for publication of information from this
information collection.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
There
are no reasons why display of the expiration date for OMB approval
of the information collection would be inappropriate.
18. Exceptions
to Certification for Paperwork Reduction Act Submissions
There
are no exceptions to the certification.
| File Type | application/msword |
| File Title | Supporting Statement for |
| Author | Joanna Capezzuto |
| Last Modified By | DPresley |
| File Modified | 2010-06-30 |
| File Created | 2010-06-30 |