82 FR 52055 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Recall Regulations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 216 (November 9, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 216 (November 9, 2017)
| Page Range | 52055-52056 | |
| FR Document | 2017-24410 |
[Federal Register Volume 82, Number 216 (Thursday, November 9, 2017)] [Notices] [Pages 52055-52056] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24410] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-1027] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Recall Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by December 11, 2017. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0188. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Infant Formula Recall Regulations--21 CFR 107.230, 107.240, 107.250, 107.260, and 107.280, OMB Control Number 0910-0188--Extension Section 412(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350a(e)) provides that if the manufacturer of an infant formula has knowledge that reasonably supports the conclusion that an infant formula processed by that manufacturer has left its control and may not provide the nutrients required in section 412(i) of the FD&C Act or is otherwise adulterated or misbranded, the manufacturer must promptly notify the Secretary of Health and Human Services (the Secretary). If the Secretary determines that the infant formula presents a risk to human health, the manufacturer must immediately take all actions necessary to recall shipments of such infant formula from all wholesale and retail establishments, consistent with recall regulations and guidelines issued by the Secretary. Section 412(f)(2) of the FD&C Act states that the Secretary shall by regulation prescribe the scope and extent of recalls of infant formula necessary and appropriate for the degree of risk to human health presented by the formula subject to recall. FDA's infant formula recall regulations in part 107 (21 CFR part 107) implement these statutory provisions. Section 107.230 requires each recalling firm to conduct an infant formula recall with the following elements: (1) Evaluate the hazard to human health, (2) devise a written recall strategy, (3) promptly notify each affected direct account (customer) about the recall, and (4) furnish the appropriate FDA district office with copies of these documents. If the recalled formula presents a risk to human health, the recalling firm must also request that each establishment that sells the recalled formula post (at point of purchase) a notice of the recall and provide FDA with a copy of the notice. Section 107.240 requires the recalling firm to conduct an infant formula recall with the following elements: (1) Notify the appropriate FDA district office of the recall by telephone within 24 hours, (2) submit a written report to that office within 14 days, and (3) submit a written status report at least every 14 days until the recall is terminated. Before terminating a recall, the recalling firm is required to submit a recommendation for termination of the recall to the appropriate FDA district office and wait for FDA's written concurrence (Sec. 107.250). Where the recall strategy or implementation is determined to be deficient, FDA may require the firm to change the extent of the recall, carry out additional effectiveness checks, and issue additional notifications (Sec. 107.260). In addition, to facilitate location of the product being recalled, the recalling firm is required to maintain distribution records for at least 1 year after the expiration of the shelf life of the infant formula (Sec. 107.280). The reporting and recordkeeping requirements described previously are designed to enable FDA to monitor the effectiveness of infant formula recalls in order to protect babies from infant formula that may be unsafe because of contamination, nutritional inadequacy, or is otherwise adulterated or misbranded. FDA uses the information collected under these regulations to help ensure that such products are quickly and efficiently removed from the market. In the Federal Register of June 15, 2017 (82 FR 27509), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one comment that was unrelated to the information collection. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of 21 CFR section/activity Number of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- 107.230; Elements of an infant 2 1 2 4,450 8,900 formula recall................. 107.240; Notification 2 1 2 1,482 2,964 requirements................... 107.250; Termination of an 2 1 2 120 240 infant formula recall.......... 107.260; Revision of an infant 1 1 1 625 625 formula recall \2\............. ------------------------------------------------------------------------------- [[Page 52056]] Total \2\................... .............. .............. .............. .............. 12,729 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ No burden has been estimated for the recordkeeping requirement in Sec. 107.280 because these records are maintained as a usual and customary part of normal business activities. Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine business practice. The reporting and third-party disclosure burden estimates are based on FDA's records, which show that there are six manufacturers of infant formula and that there have been, on average, two infant formula recalls per year for the past 3 years. Based on this information, FDA estimates that there will be, on average, approximately two infant formula recalls per year over the next 3 years. Thus, FDA estimates that two respondents will conduct recalls annually under Sec. Sec. 107.230, 107.240, and 107.250. The estimated number of respondents for Sec. 107.260 is minimal because FDA seldom uses this section; therefore, FDA estimates that there will be one or fewer respondents annually for Sec. 107.260. The estimated number of hours per response is an average based on FDA's experience and information from firms that have conducted recalls. FDA estimates that two respondents will conduct infant formula recalls under Sec. 107.230 and that it will take a respondent 4,450 hours to comply with the requirements of that section, for a total of 8,900 hours. FDA estimates that two respondents will conduct infant formula recalls under Sec. 107.240 and that it will take a respondent 1,482 hours to comply with the requirements of that section, for a total of 2,964 hours. FDA estimates that two respondents will submit recommendations for termination of infant formula recalls under Sec. 107.250 and that it will take a respondent 120 hours to comply with the requirements of that section, for a total of 240 hours. Finally, FDA estimates that one respondent will need to carry out additional effectiveness checks and issue additional notifications, for a total of 625 hours. Under 5 CFR 1320.3(b)(2), the time, effort, and financial resources necessary to comply with a collection of information are excluded from the burden estimate if the reporting, recordkeeping, or disclosure activities needed to comply are usual and customary because they would occur in the normal course of activities. No burden has been estimated for the recordkeeping requirement in Sec. 107.280 because these records are maintained as a usual and customary part of normal business activities. Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine business practice. Table 2--Estimated Annual Third-Party Disclosure Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of 21 CFR section/activity Number of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- 107.230; Elements of an infant 2 1 2 50 100 formula recall................. 107.260; Revision of an infant 1 1 1 25 25 formula recall................. ------------------------------------------------------------------------------- Total \2\................... .............. .............. .............. .............. 125 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2 reports FDA's third-party disclosure burden estimates for Sec. Sec. 107.230 and 107.260. The estimated burden hours per disclosure is an average based on FDA's experience. The third-party disclosure burden in Sec. 107.230 is the requirement to promptly notify each affected direct account (customer) about the recall, and if the recalled formula presents a risk to human health, the recalling firm must also request that each establishment that sells the recalled formula post a notice of the recall at the point of purchase. FDA estimates that two respondents will conduct infant formula recalls under Sec. 107.230 and that it will take a respondent 50 hours to comply with the third-party disclosure requirements of that section, for a total of 100 hours. The third-party disclosure burden in Sec. 107.260 is the requirement to issue additional notifications where the recall strategy or implementation is determined to be deficient. FDA estimates that one respondent will issue additional notifications under Sec. 107.260 and that it will take a respondent 25 hours to comply with the third-party disclosure requirements of that section, for a total of 25 hours. Dated: November 6, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-24410 Filed 11-8-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices 52055
Agency identify and respond to Landsdown St., North Bethesda, MD recalled formula presents a risk to
emerging issues in a more timely 20852, 301–796–7726, PRAStaff@ human health, the recalling firm must
manner. fda.hhs.gov. also request that each establishment that
Dated: November 6, 2017. SUPPLEMENTARY INFORMATION: In sells the recalled formula post (at point
Anna K. Abram, compliance with 44 U.S.C. 3507, FDA of purchase) a notice of the recall and
has submitted the following proposed provide FDA with a copy of the notice.
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis. collection of information to OMB for Section 107.240 requires the recalling
review and clearance. firm to conduct an infant formula recall
[FR Doc. 2017–24409 Filed 11–8–17; 8:45 am]
with the following elements: (1) Notify
BILLING CODE 4164–01–P Infant Formula Recall Regulations—21 the appropriate FDA district office of
CFR 107.230, 107.240, 107.250, 107.260, the recall by telephone within 24 hours,
and 107.280, OMB Control Number (2) submit a written report to that office
DEPARTMENT OF HEALTH AND 0910–0188—Extension
HUMAN SERVICES within 14 days, and (3) submit a written
Section 412(e) of the Federal Food, status report at least every 14 days until
Food and Drug Administration Drug, and Cosmetic Act (the FD&C Act) the recall is terminated. Before
(21 U.S.C. 350a(e)) provides that if the terminating a recall, the recalling firm is
[Docket No. FDA–2014–N–1027] manufacturer of an infant formula has required to submit a recommendation
knowledge that reasonably supports the for termination of the recall to the
Agency Information Collection
conclusion that an infant formula appropriate FDA district office and wait
Activities; Submission for Office of
processed by that manufacturer has left for FDA’s written concurrence
Management and Budget Review;
its control and may not provide the (§ 107.250). Where the recall strategy or
Comment Request; Infant Formula
nutrients required in section 412(i) of implementation is determined to be
Recall Regulations
the FD&C Act or is otherwise deficient, FDA may require the firm to
AGENCY: Food and Drug Administration, adulterated or misbranded, the change the extent of the recall, carry out
HHS. manufacturer must promptly notify the additional effectiveness checks, and
ACTION: Notice. Secretary of Health and Human Services issue additional notifications
(the Secretary). If the Secretary (§ 107.260). In addition, to facilitate
SUMMARY: The Food and Drug determines that the infant formula location of the product being recalled,
Administration (FDA or we) is presents a risk to human health, the the recalling firm is required to
announcing that a proposed collection manufacturer must immediately take all maintain distribution records for at least
of information has been submitted to the actions necessary to recall shipments of 1 year after the expiration of the shelf
Office of Management and Budget such infant formula from all wholesale life of the infant formula (§ 107.280).
(OMB) for review and clearance under and retail establishments, consistent The reporting and recordkeeping
the Paperwork Reduction Act of 1995. with recall regulations and guidelines requirements described previously are
DATES: Fax written comments on the issued by the Secretary. Section designed to enable FDA to monitor the
collection of information by December 412(f)(2) of the FD&C Act states that the effectiveness of infant formula recalls in
11, 2017. Secretary shall by regulation prescribe order to protect babies from infant
ADDRESSES: To ensure that comments on
the scope and extent of recalls of infant formula that may be unsafe because of
the information collection are received, formula necessary and appropriate for contamination, nutritional inadequacy,
OMB recommends that written the degree of risk to human health or is otherwise adulterated or
comments be faxed to the Office of presented by the formula subject to misbranded. FDA uses the information
recall. FDA’s infant formula recall collected under these regulations to
Information and Regulatory Affairs,
regulations in part 107 (21 CFR part
OMB, Attn: FDA Desk Officer, Fax: 202– help ensure that such products are
107) implement these statutory
395–7285, or emailed to oira_ quickly and efficiently removed from
provisions.
submission@omb.eop.gov. All Section 107.230 requires each the market.
comments should be identified with the recalling firm to conduct an infant In the Federal Register of June 15,
OMB control number 0910–0188. Also formula recall with the following 2017 (82 FR 27509), FDA published a
include the FDA docket number found elements: (1) Evaluate the hazard to 60-day notice requesting public
in brackets in the heading of this human health, (2) devise a written recall comment on the proposed collection of
document. strategy, (3) promptly notify each information. FDA received one
FOR FURTHER INFORMATION CONTACT: Ila affected direct account (customer) about comment that was unrelated to the
S. Mizrachi, Office of Operations, Food the recall, and (4) furnish the information collection.
and Drug Administration, Three White appropriate FDA district office with FDA estimates the burden of this
Flint North, 10A–12M, 11601 copies of these documents. If the collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of responses Total annual
21 CFR section/activity burden per Total hours
respondents per responses response
respondent
sradovich on DSK3GMQ082PROD with NOTICES
107.230; Elements of an infant formula recall ..................... 2 1 2 4,450 8,900
107.240; Notification requirements ...................................... 2 1 2 1,482 2,964
107.250; Termination of an infant formula recall ................. 2 1 2 120 240
107.260; Revision of an infant formula recall 2 .................... 1 1 1 625 625
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![52056 Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of Average
Number of responses Total annual
21 CFR section/activity burden per Total hours
respondents per responses response
respondent
Total 2 ............................................................................ ........................ ........................ ........................ ........................ 12,729
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 No burden has been estimated for the recordkeeping requirement in § 107.280 because these records are maintained as a usual and cus-
tomary part of normal business activities. Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine
business practice.
The reporting and third-party on FDA’s experience and information to carry out additional effectiveness
disclosure burden estimates are based from firms that have conducted recalls. checks and issue additional
on FDA’s records, which show that FDA estimates that two respondents notifications, for a total of 625 hours.
there are six manufacturers of infant will conduct infant formula recalls Under 5 CFR 1320.3(b)(2), the time,
formula and that there have been, on under § 107.230 and that it will take a effort, and financial resources necessary
average, two infant formula recalls per respondent 4,450 hours to comply with
to comply with a collection of
year for the past 3 years. Based on this the requirements of that section, for a
information are excluded from the
information, FDA estimates that there total of 8,900 hours. FDA estimates that
will be, on average, approximately two two respondents will conduct infant burden estimate if the reporting,
infant formula recalls per year over the formula recalls under § 107.240 and that recordkeeping, or disclosure activities
next 3 years. it will take a respondent 1,482 hours to needed to comply are usual and
Thus, FDA estimates that two comply with the requirements of that customary because they would occur in
respondents will conduct recalls section, for a total of 2,964 hours. FDA the normal course of activities. No
annually under §§ 107.230, 107.240, and estimates that two respondents will burden has been estimated for the
107.250. The estimated number of submit recommendations for recordkeeping requirement in § 107.280
respondents for § 107.260 is minimal termination of infant formula recalls because these records are maintained as
because FDA seldom uses this section; under § 107.250 and that it will take a a usual and customary part of normal
therefore, FDA estimates that there will respondent 120 hours to comply with business activities. Manufacturers keep
be one or fewer respondents annually the requirements of that section, for a infant formula distribution records for
for § 107.260. The estimated number of total of 240 hours. Finally, FDA the prescribed period as a matter of
hours per response is an average based estimates that one respondent will need routine business practice.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of responses Total annual
21 CFR section/activity burden per Total hours
respondents per responses response
respondent
107.230; Elements of an infant formula recall ..................... 2 1 2 50 100
107.260; Revision of an infant formula recall ...................... 1 1 1 25 25
Total 2 ............................................................................ ........................ ........................ ........................ ........................ 125
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2 reports FDA’s third-party § 107.260 is the requirement to issue DEPARTMENT OF HEALTH AND
disclosure burden estimates for additional notifications where the recall HUMAN SERVICES
§§ 107.230 and 107.260. The estimated strategy or implementation is
burden hours per disclosure is an determined to be deficient. FDA Food and Drug Administration
average based on FDA’s experience. The estimates that one respondent will issue
third-party disclosure burden in [Docket No. FDA–2014–N–1414]
additional notifications under § 107.260
§ 107.230 is the requirement to and that it will take a respondent 25 Agency Information Collection
promptly notify each affected direct hours to comply with the third-party Activities; Proposed Collection;
account (customer) about the recall, and disclosure requirements of that section, Comment Request; Class II Special
if the recalled formula presents a risk to for a total of 25 hours. Controls Guidance Document:
human health, the recalling firm must
Dated: November 6, 2017. Labeling Natural Rubber Latex
also request that each establishment that
Condoms
sells the recalled formula post a notice Anna K. Abram,
of the recall at the point of purchase.
sradovich on DSK3GMQ082PROD with NOTICES
Deputy Commissioner for Policy, Planning, AGENCY: Food and Drug Administration,
FDA estimates that two respondents Legislation, and Analysis. HHS.
will conduct infant formula recalls [FR Doc. 2017–24410 Filed 11–8–17; 8:45 am] ACTION: Notice.
under § 107.230 and that it will take a BILLING CODE 4164–01–P
respondent 50 hours to comply with the SUMMARY: The Food and Drug
third-party disclosure requirements of Administration (FDA or Agency) is
that section, for a total of 100 hours. The announcing an opportunity for public
third-party disclosure burden in comment on the proposed collection of
VerDate Sep<11>2014 17:32 Nov 08, 2017 Jkt 244001 PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 E:\FR\FM\09NON1.SGM 09NON1](https://thefederalregister.org/doc/82_FR_52271/page/2.svg)
Document Created: 2018-10-25 10:29:39
Document Modified: 2018-10-25 10:29:39
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by December 11, 2017. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 82 FR 52055 |
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