Draft Guidance for Industry: Demonstration of the Quality Factor Requirements for “Eligible” Infant Formulas; Availability, 7609-7610 [2014-02731]

Download as PDF Federal Register / Vol. 79, No. 27 / Monday, February 10, 2014 / Proposed Rules Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425–227–1221. (l) Other FAA AD Provisions The following provisions also apply to this AD: (1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM–116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Branch, send it to ATTN: Sanjay Ralhan, Aerospace Engineer, International Branch, ANM–116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, Washington 98057– 3356; telephone (425) 227–1405; fax (425) 227–1149. Information may be emailed to: 9ANM-116-AMOC-REQUESTS@faa.gov. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/ certificate holding district office. The AMOC approval letter must specifically reference this AD. (2) Airworthy Product: For any requirement in this AD to obtain corrective actions from a manufacturer, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they were approved by the State of Design Authority (or its delegated agent, or the Design Approval Holder with a State of Design Authority’s design organization approval, as applicable). For a repair method to be approved, the repair approval must specifically refer to this AD. You are required to ensure the product is airworthy before it is returned to service. emcdonald on DSK67QTVN1PROD with PROPOSALS (k) Credit for Previous Actions This paragraph provides credit for the actions required by paragraph (h) of this AD, if those actions were performed before the effective date of this AD using the service information specified in paragraph (k)(1) or (k)(2) of this AD. (1) B/E AEROSPACE Service Bulletin 1XCXX–0100–35–005, dated March 14, 2011. (2) B/E AEROSPACE Service Bulletin 22CXX–0100–35–003, dated March 17, 2011. BILLING CODE 4910–13–C (m) Related Information (1) Refer to Mandatory Continuing Airworthiness Information European Aviation Safety Agency Airworthiness Directive 2012–0083, dated May 16, 2012, for related information. This may be found in the AD docket on the Internet at https:// www.regulations.gov by searching for and locating it in Docket No. FAA–2012–0807. (2) For service information identified in this AD, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email account.airworth-eas@ airbus.com; Internet https://www.airbus.com. For B/E service information identified in this proposed AD, contact B/E Aerospace Systems GmbH, Revalstrasse 1, 23560 Lubeck, Germany; telephone (49) 451 4093–2976; fax (49) 451 4093–4488. You may view this referenced service information at the FAA, VerDate Mar<15>2010 17:14 Feb 07, 2014 Jkt 232001 Issued in Renton, Washington, on January 21, 2014. Jeffrey E. Duven, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. 2014–02722 Filed 2–7–14; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 106 [Docket No. FDA–2014–D–0033] Draft Guidance for Industry: Demonstration of the Quality Factor Requirements for ‘‘Eligible’’ Infant Formulas; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance entitled ‘‘Guidance for Industry: Demonstration of the Quality Factor Requirements for ‘Eligible’ Infant Formulas.’’ The draft guidance, when finalized, will describe our current thinking on the quality factor requirements for eligible infant formulas, the record requirements for eligible infant formulas, and the submission of citizen petitions for eligible infant formulas. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on this draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 27, 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 to the Division of Dockets SUMMARY: PO 00000 Frm 00018 Fmt 4702 Sfmt 4702 7609 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 a draft guidance for industry entitled ‘‘Guidance for Industry: Demonstration of the Quality Factor Requirements Under 21 CFR 106.96(i) for ‘Eligible’ Infant Formulas.’’ This draft guidance is being issued consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent our current thinking on this topic. 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. The draft guidance is intended to address questions regarding new requirements for eligible infant formulas in § 106.96(i). An interim final rule amending part 106, and establishing the requirements under § 106.96(i), is published elsewhere in this issue of the Federal Register. II. Paperwork Reduction Act of 1995 This draft guidance refers to proposed collections of information described in FDA’s interim final rule on current good manufacturing practices for infant formula published elsewhere in this issue of the Federal Register, which this draft guidance is intended to interpret. The proposed collections of information in the interim final rule are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501–3520). As required by the PRA, FDA has provided a description of these provisions with estimates of the annual reporting, recordkeeping, and third-party disclosure burden in section IV of the Regulatory Impact Analysis for the interim final rule, entitled ‘‘Paperwork Reduction Act of 1995’’ (Ref. 92 to the interim final rule) and has submitted them for OMB approval. III. Comments Interested persons may submit either electronic comments regarding the guidance 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 E:\FR\FM\10FEP1.SGM 10FEP1 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]
[Pages 7609-7610]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02731]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 106

[Docket No. FDA-2014-D-0033]


Draft Guidance for Industry: Demonstration of the Quality Factor 
Requirements for ``Eligible'' Infant Formulas; 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 a draft guidance entitled ``Guidance for Industry: 
Demonstration of the Quality Factor Requirements for `Eligible' Infant 
Formulas.'' The draft guidance, when finalized, will describe our 
current thinking on the quality factor requirements for eligible infant 
formulas, the record requirements for eligible infant formulas, and the 
submission of citizen petitions for eligible infant formulas.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that we consider your comment on this draft 
guidance before we begin work on the final version of the guidance, 
submit either electronic or written comments on the draft guidance by 
March 27, 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 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 a draft guidance for industry 
entitled ``Guidance for Industry: Demonstration of the Quality Factor 
Requirements Under 21 CFR 106.96(i) for `Eligible' Infant Formulas.'' 
This draft guidance is being issued consistent with our good guidance 
practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent our current thinking on this topic. 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.
    The draft guidance is intended to address questions regarding new 
requirements for eligible infant formulas in Sec.  106.96(i). An 
interim final rule amending part 106, and establishing the requirements 
under Sec.  106.96(i), is published elsewhere in this issue of the 
Federal Register.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to proposed collections of information 
described in FDA's interim final rule on current good manufacturing 
practices for infant formula published elsewhere in this issue of the 
Federal Register, which this draft guidance is intended to interpret. 
The proposed collections of information in the interim final rule are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). As 
required by the PRA, FDA has provided a description of these provisions 
with estimates of the annual reporting, recordkeeping, and third-party 
disclosure burden in section IV of the Regulatory Impact Analysis for 
the interim final rule, entitled ``Paperwork Reduction Act of 1995'' 
(Ref. 92 to the interim final rule) and has submitted them for OMB 
approval.

III. Comments

    Interested persons may submit either electronic comments regarding 
the guidance 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

[[Page 7610]]

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

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