Draft Guidance for Industry; Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records and Reports; Availability, 7610 [2014-02732]

Download as PDF 7610 Federal Register / Vol. 79, No. 27 / Monday, February 10, 2014 / Proposed Rules comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the draft guidance at https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance. Dated: February 4, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–02731 Filed 2–6–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration I. Background 21 CFR Part 106 [Docket No. FDA–2014–D–0044] Draft Guidance for Industry; Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records and Reports; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. The Food and Drug Administration (FDA or we) is announcing the availability of the draft guidance entitled ‘‘Guidance for Industry; Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports.’’ The draft guidance, when finalized, will describe our current thinking on the manufacturing of exempt infant formula in relation to the requirements for CGMPs, quality control procedures, conduct of audits, and records and reports that apply to nonexempt infant formulas. DATES: Although you may comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on the draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 12, 2014. emcdonald on DSK67QTVN1PROD with PROPOSALS SUMMARY: VerDate Mar<15>2010 17:14 Feb 07, 2014 Jkt 232001 Submit written requests for single copies of the draft guidance to the Office of Nutrition, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition (HFS– 850), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments on the draft guidance to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Benson M. Silverman, Center for Food Safety and Applied Nutrition (HFS– 850), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–1459. SUPPLEMENTARY INFORMATION: ADDRESSES: We are announcing the availability of the draft guidance entitled ‘‘Guidance for Industry; Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Audit Procedures, and Records and Reports.’’ Section 412(h)(1) (21 U.S.C. 350a(h)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) exempts an infant formula which is represented and labeled for use by an infant with an inborn error of metabolism, low birth weight, or who otherwise has an unusual medical or dietary problem from sections 412(a), (b), and (c) of the FD&C Act. These formulas are customarily referred to as ‘‘exempt infant formulas.’’ The draft guidance is intended to describe the significance of the regulations in 21 CFR part 106 for production of exempt infant formulas. Amendments to part 106, in the form of an interim final rule, are published elsewhere in this issue of the Federal Register. We are issuing this draft guidance as Level 1 draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent our current thinking on the manufacturing of exempt infant formulas in relation to the requirements for CGMPs, quality control procedures, conduct of audits, and records and reports for nonexempt infant formulas in part 106. It does not create or confer any rights for or on any person and does not operate to bind PO 00000 Frm 00019 Fmt 4702 Sfmt 9990 FDA or the public. An alternate approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501– 3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to publish notice in the Federal Register soliciting public comment on each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA will publish a 60-day notice on the proposed collection of information in a future issue of the Federal Register. III. Comments Interested persons may submit either electronic comments regarding the draft guidance and proposed collection of information to https:// www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the draft guidance at https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance. Dated: February 4, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–02732 Filed 2–6–14; 8:45 am] BILLING CODE 4160–01–P E:\FR\FM\10FEP1.SGM 10FEP1

Agencies

[Federal Register Volume 79, Number 27 (Monday, February 10, 2014)]
[Proposed Rules]
[Page 7610]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02732]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 106

[Docket No. FDA-2014-D-0044]

Draft Guidance for Industry; Exempt Infant Formula Production:
Current Good Manufacturing Practices, Quality Control Procedures,
Conduct of Audits, and Records and Reports; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of the draft guidance entitled ``Guidance for Industry;
Exempt Infant Formula Production: Current Good Manufacturing Practices
(CGMPs), Quality Control Procedures, Conduct of Audits, and Records and
Reports.'' The draft guidance, when finalized, will describe our
current thinking on the manufacturing of exempt infant formula in
relation to the requirements for CGMPs, quality control procedures,
conduct of audits, and records and reports that apply to nonexempt
infant formulas.

DATES: Although you may comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on the
draft guidance before we begin work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 12, 2014.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Nutrition, Labeling, and Dietary Supplements,
Center for Food Safety and Applied Nutrition (HFS-850), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send
two self-addressed adhesive labels to assist that office in processing
your request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance.
Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments on the draft guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Benson M. Silverman, Center for Food
Safety and Applied Nutrition (HFS-850), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1459.

SUPPLEMENTARY INFORMATION:

I. Background

We are announcing the availability of the draft guidance entitled
``Guidance for Industry; Exempt Infant Formula Production: Current Good
Manufacturing Practices (CGMPs), Quality Control Procedures, Audit
Procedures, and Records and Reports.'' Section 412(h)(1) (21 U.S.C.
350a(h)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
exempts an infant formula which is represented and labeled for use by
an infant with an inborn error of metabolism, low birth weight, or who
otherwise has an unusual medical or dietary problem from sections
412(a), (b), and (c) of the FD&C Act. These formulas are customarily
referred to as ``exempt infant formulas.'' The draft guidance is
intended to describe the significance of the regulations in 21 CFR part
106 for production of exempt infant formulas. Amendments to part 106,
in the form of an interim final rule, are published elsewhere in this
issue of the Federal Register.
We are issuing this draft guidance as Level 1 draft guidance
consistent with our good guidance practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will represent our current thinking
on the manufacturing of exempt infant formulas in relation to the
requirements for CGMPs, quality control procedures, conduct of audits,
and records and reports for nonexempt infant formulas in part 106. It
does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternate approach may be used if
such approach satisfies the requirements of the applicable statutes and
regulations.

II. Paperwork Reduction Act of 1995

Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to publish
notice in the Federal Register soliciting public comment on each
proposed collection of information before submitting the collection to
OMB for approval. To comply with this requirement, FDA will publish a
60-day notice on the proposed collection of information in a future
issue of the Federal Register.

III. Comments

Interested persons may submit either electronic comments regarding
the draft guidance and proposed collection of information to https://www.regulations.gov or written comments to the Division of Dockets
Management (see ADDRESSES). It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at https://www.regulations.gov.

IV. Electronic Access

Persons with access to the Internet may obtain the draft guidance
at https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use
the FDA Web site listed in the previous sentence to find the most
current version of the guidance.

Dated: February 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02732 Filed 2-6-14; 8:45 am]
BILLING CODE 4160-01-P

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