SUPPORTING STATEMENT
Terms of Clearance: None.
1. Circumstances
Making the Collection of Information Necessary
Statutory
requirements for infant formula under the Federal Food, Drug, and
Cosmetic Act (the FD&C 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 FD&C Act (21
U.S.C. 350a) requires manufacturers of infant formula to establish
and adhere to quality control procedures, notify us when a batch of
infant formula that has left the manufacturers' control may be
adulterated or misbranded, and keep records of distribution. We have
issued regulations to implement the FD&C Act's requirements for
infant formula in parts 106 and 107 (21 CFR parts 106 and 107). We
also regulate the labeling of infant formula under the authority of
section 403 of the FD&C Act (21 U.S.C. 343). Under our 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), we proposed changes in our 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 Federal Register of April 28, 2003 (68 FR 22341) (the 2003 reopening), FDA reopened the comment period for the proposed rule. Interested persons were originally given until June 27, 2003, to comment on these issues and the 1996 proposal. However, in response to a request, the comment period was extended to August 26, 2003 (68 FR 38247, June 27, 2003). FDA again reopened the comment period on August 1, 2006 (71 FR 43392) (the 2006 reopening) for 45 days to accept comment on a limited set of issues. In a notice of proposed rulemaking published in the Federal Register of April 16, 2013 (78 FR 22442), we proposed to amend our regulations on nutrient specifications and labeling for infant formula to add the mineral selenium to the list of required nutrients and to establish minimum and maximum levels of selenium in infant formula. The document also included revised burden estimates for the proposed changes and solicited public comment. In the interim, FDA is seeking an extension of OMB approval for the current regulations so that we can continue to collect information while the proposals are 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 FD&C 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 - Recordkeeping
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) – Third Party Disclosure
Requirement for specific nutrient information to be displayed on infant formula labeling.
21 CFR 107.20 - Third Party Disclosure
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) - Recordkeeping
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 FD&C Act 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 complying with its requirements through the
agency’s Regional Small Business Representatives and through
the scientific and administrative staffs within the agency. FDA has
provided a Small Business Guide on the agency’s website at
http://www.fda.gov/oc/industry/.
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 Infant Formula Act of 1980 (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 16,
2013 (78 FR 28854), FDA published a 60-day notice requesting public
comment on the proposed extension of this collection of information
collection. 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:
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 FD&C Act, submit formulation information to FDA. |
5 |
13 |
65 |
10 |
650 |
21 CFR 106.120(b), notify FDA of adulteration or misbranding. |
1 |
1 |
1 |
4 |
4 |
21 CFR 107.50(b)(3) and (b)(4), Submit formulation information to FDA to maintain exempt status |
3 |
2 |
6 |
4 |
24 |
21 CFR 107.50(e)(2), notify FDA of adulteration or misbranding of exempt formula. |
1 |
1 |
1 |
4 |
4 |
Total |
|
|
|
|
682 |
Table 1.--Estimated Annual Reporting Burden1
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, recordkeeping associated with microbiological/nutrient testing, quality control procedures, audits and investigation of consumer complaints. |
5 |
10 |
50 |
400 |
20,000 |
107.50(c)(3), recordkeeping associated with quality control procedures. |
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, labeling requirements for specific nutrient information and directions for use. |
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, we consulted our records of the number of infant formula submissions received in the past. All infant formula submissions may be provided to us in electronic format. The hours per response reporting estimates are based on our experience with similar programs and information received from industry.
We estimate that we will receive 13 reports from 5 manufacturers annually under section 412(d) of the FD&C 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. We also estimate that we 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, we estimate that we 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. We also estimate that we will receive one notification annually under § 107.50(e) (2) and that the notification will take 4 hours to prepare.
We estimate that 5 firms will expend approximately 20,000 hours per year to fully satisfy the recordkeeping requirements in § 106.100 and that 3 firms will expend approximately 9,000 hours per year to fully satisfy the recordkeeping requirements in § 107.50(c)(3).
We estimate compliance with our labeling requirements in §§ 107.10(a) and 107.20 requires 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 2013, $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 2013 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 2013 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 | Bean, Domini |
| File Modified | 2013-10-28 |
| File Created | 2013-10-28 |