Guidance for Industry: Demonstration of the Quality Factor Requirements for “Eligible” Infant Formulas; Availability, 33056-33057 [2014-13386]

Download as PDF 33056 Federal Register / Vol. 79, No. 111 / Tuesday, June 10, 2014 / Rules and Regulations the FAA amends 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: ■ Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): ■ 2014–07–52 Airbus Helicopters (previously Eurocopter France): Amendment 39– 17858; Docket No. FAA–2014–0334; Directorate Identifier 2014–SW–021–AD. (a) Applicability This AD applies to Airbus Helicopters Model AS350B, AS350BA, AS350B1, AS350B2, AS350B3, AS350C, AS350D, AS350D1, AS355E, AS355F, AS355F1, AS355F2, AS355N, and AS355NP helicopters, certificated in any category, with: (1) Modification (MOD) 07 3215 installed; or (2) With a reinforcement angle, part number (P/N) 350A08.2493.21 or P/N 350A08.2493.23, installed. (b) Unsafe Condition This AD defines the unsafe condition as a crack in a rear structure to tailboom junction frame reinforcement angle (reinforcement angle), which if not detected could result in loss of the tailboom and subsequent loss of control of the helicopter. (c) Effective Date This AD becomes effective June 25, 2014 to all persons except those persons to whom it was made immediately effective by Emergency AD 2014–07–52, issued on March 28, 2014, which contained the requirements of this AD. emcdonald on DSK67QTVN1PROD with RULES (d) Compliance You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time. (e) Required Actions (1) For helicopters with 640 or more hours time-in-service (TIS) since installation of MOD 07 3215 or since installation of an applicable reinforcement angle, within 10 hours TIS, and thereafter, at intervals not exceeding 10 hours TIS, inspect each reinforcement angle for a crack as depicted in Figure 1 of Airbus Helicopters Emergency Alert Service Bulletin No. 05.00.70 for Model AS350B, AS350BA, AS350B1, AS350B2, AS350B3, AS350C, AS350D, AS350D1 helicopters and Airbus Helicopters Emergency Alert Service Bulletin No. 05.00.62 for AS355E, AS355F, AS355F1, AS355F2, AS355N, and AS355NP helicopters, both Revision 0 and dated March 24, 2014. (2) If there is a crack, before further flight, repair the reinforcement angle in a manner VerDate Mar<15>2010 16:04 Jun 09, 2014 Jkt 232001 approved by the manager listed in paragraph (f)(1) of this AD. (3) As an optional terminating action for the repetitive inspections required by paragraph (e)(1) of this AD, at intervals not exceeding 165 hours TIS, remove screw No. 5 from the reinforcement angle, thoroughly clean the area around the hole and inspect the reinforcement angle for a crack. If there is not a crack, reinstall the screw. Sequentially repeat the steps required by this paragraph for screws No. 6 through No. 12. If there is a crack, comply with paragraph (e)(2) of this AD. (f) Alternative Methods of Compliance (AMOCs) (1) The Manager, Safety Management Group, FAA, may approve AMOCs for this AD. Send your proposal to: Robert Grant, Aviation Safety Engineer, Safety Management Group, FAA, 2601 Meacham Blvd., Fort Worth, Texas 76137; telephone (817) 222– 5110; email robert.grant@faa.gov. (2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, we suggest that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office, before operating any aircraft complying with this AD through an AMOC. (g) Additional Information The subject of this AD is addressed in European Aviation Safety Agency (EASA) Emergency AD No. 2014–0076–E, dated March 25, 2014. You may view the EASA Emergency AD on the Internet at https:// www.regulations.gov in Docket No. FAA– 2014–0334. (h) Subject Joint Aircraft Service Component (JASC) Code: 5302: Rotorcraft Tailboom. (i) Material Incorporated by Reference (1) The Director of the Federal Register approved the incorporation by reference of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51. (2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise. (i) Airbus Helicopters Emergency Alert Service Bulletin No. 05.00.62, Revision 0, dated March 24, 2014. (ii) Airbus Helicopters Emergency Alert Service Bulletin No. 05.00.70, Revision 0, dated March 24, 2014. Note 1 to paragraph (i)(2): Airbus Helicopters Emergency Alert Service Bulletin (EASB) No. 05.00.62, Revision 0, dated March 24, 2014, and Airbus Helicopters EASB No. 05.00.70, Revision 0, dated March 24, 2014, are co-published as one document along with Airbus Helicopters EASB No. 05.00.45, Revision 0, dated March 24, 2014, and Airbus Helicopters EASB No. 05.00.41, Revision 0, dated March 24, 2014, which are not incorporated by reference in this AD. (3) For Airbus Helicopters service information identified in this AD, contact Airbus Helicopters, Inc., 2701 N. Forum PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 Drive, Grand Prairie, TX 75052; telephone (972) 641–0000 or (800) 232–0323; fax (972) 641–3775; or at https:// www.airbushelicopters.com/techpub. (4) You may view this service information at FAA, Office of the Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas 76137. For information on the availability of this material at the FAA, call (817) 222–5110. (5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741–6030, or go to: https:// www.archives.gov/federal-register/cfr/ibrlocations.html. Issued in Fort Worth, Texas, on May 21, 2014. Lance T. Gant, Acting Directorate Manager, Rotorcraft Directorate, Aircraft Certification Service. [FR Doc. 2014–12724 Filed 6–9–14; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 106 [Docket No. FDA–2014–D–0033] 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 final guidance which describes 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: Submit either electronic or written comments on FDA guidances at any time. ADDRESSES: Submit written requests for single copies of the 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 guidance. Submit electronic comments on the guidance to https://www.regulations.gov. SUMMARY: E:\FR\FM\10JNR1.SGM 10JNR1 Federal Register / Vol. 79, No. 111 / Tuesday, June 10, 2014 / Rules and Regulations 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, 240–402–1451. SUPPLEMENTARY INFORMATION: emcdonald on DSK67QTVN1PROD with RULES I. Background We are announcing the availability of a guidance for industry entitled ‘‘Guidance for Industry: Demonstration of the Quality Factor Requirements Under 21 CFR 106.96(i) for ‘Eligible’ Infant Formulas.’’ This guidance is being issued consistent with our good guidance practices regulation (21 CFR 10.115). The guidance represents 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 guidance is intended to address questions regarding new requirements for eligible infant formulas in 21 CFR 106.96(i). A final rule amending part 106, and establishing the requirements under § 106.96(i), is published elsewhere in this issue of the Federal Register. In the Federal Register of February 10, 2014 (79 FR 7609), we made available a draft guidance entitled ‘‘Draft Guidance for Industry: Demonstration of the Quality Factor Requirements for ‘Eligible’ Infant Formulas’’ and gave interested parties an opportunity to submit comments by March 27, 2014, for us to consider before beginning work on the final version of the guidance. We received no comments on the draft guidance but have modified the final guidance where appropriate to correspond to requirements set forth in the final rule, ‘‘Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula,’’ published elsewhere in this issue of the Federal Register. For example, because the final rule revised the definition of an ‘‘eligible infant formula’’ from what was originally published in an interim final rule on February 10, 2014 (79 FR 7934), we revised the guidance to reflect that change. In addition, we revised the guidance to provide more detailed recommendations if a manufacturer VerDate Mar<15>2010 16:04 Jun 09, 2014 Jkt 232001 includes proprietary information in its citizen petition submitted in accordance with § 106.96(i)(3). Furthermore, we made other edits so that the language in the guidance corresponds more closely to that used in the final rule. The guidance announced in this document finalizes the draft guidance dated February 2014. II. Paperwork Reduction Act of 1995 This guidance refers to existing regulations in part 10 (21 CFR part 10) as well as the final rule, ‘‘Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula,’’ published elsewhere in this issue of the Federal Register, which amends parts 106 and 107 (21 CFR parts 106 and 107). The collection of information in part 10 has been approved under OMB control number 0910–0183. The collections of information in parts 106 and 107 have been approved under OMB control number 0910–0256. These collections of information amended by the final rule are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The Information Collection Request for the final rule is currently under review. 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 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 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: June 4, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–13386 Filed 6–9–14; 8:45 am] BILLING CODE 4160–01–P PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 33057 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 106 and 107 [Docket No. FDA–1995–N–0063 (formerly 95N–0309)] RIN 0910–AF27 Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. The Food and Drug Administration (FDA or we) is issuing a final rule that adopts, with some modifications, the interim final rule (IFR) entitled ‘‘Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula’’ (February 10, 2014). This final rule affirms the IFR’s changes to FDA’s regulations and provides additional modifications and clarifications. The final rule also responds to certain comments submitted in response to the request for comments in the IFR. DATES: This final rule is effective July 10, 2014. The compliance date for manufacturers to meet the requirements of §§ 106.96(a), 106.96(e), 106.96(i)(5), 106.100(p)(2) and 106.100(q)(2) related to quality factors for eligible infant formulas is November 12, 2015. The compliance date for the remaining provisions of this final rule is September 8, 2014. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by July 10, 2014 (see section VII, the ‘‘Paperwork Reduction Act of 1995’’ section of this document). ADDRESSES: To ensure that comments on the information collection are received, the Office of Management and Budget (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 oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0256 and titled ‘‘Infant Formula Requirements.’’ Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Benson M. Silverman, Office of SUMMARY: E:\FR\FM\10JNR1.SGM 10JNR1

Agencies

[Federal Register Volume 79, Number 111 (Tuesday, June 10, 2014)]
[Rules and Regulations]
[Pages 33056-33057]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13386]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 106

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


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 final guidance which describes 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: Submit either electronic or written comments on FDA guidances at 
any time.

ADDRESSES: Submit written requests for single copies of the 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 guidance.
    Submit electronic comments on the guidance to https://www.regulations.gov.

[[Page 33057]]

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, 240-402-1451.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``Guidance for Industry: Demonstration of the Quality Factor 
Requirements Under 21 CFR 106.96(i) for `Eligible' Infant Formulas.'' 
This guidance is being issued consistent with our good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 guidance is intended to address questions regarding new 
requirements for eligible infant formulas in 21 CFR 106.96(i). A final 
rule amending part 106, and establishing the requirements under Sec.  
106.96(i), is published elsewhere in this issue of the Federal 
Register.
    In the Federal Register of February 10, 2014 (79 FR 7609), we made 
available a draft guidance entitled ``Draft Guidance for Industry: 
Demonstration of the Quality Factor Requirements for `Eligible' Infant 
Formulas'' and gave interested parties an opportunity to submit 
comments by March 27, 2014, for us to consider before beginning work on 
the final version of the guidance. We received no comments on the draft 
guidance but have modified the final guidance where appropriate to 
correspond to requirements set forth in the final rule, ``Current Good 
Manufacturing Practices, Quality Control Procedures, Quality Factors, 
Notification Requirements, and Records and Reports, for Infant 
Formula,'' published elsewhere in this issue of the Federal Register. 
For example, because the final rule revised the definition of an 
``eligible infant formula'' from what was originally published in an 
interim final rule on February 10, 2014 (79 FR 7934), we revised the 
guidance to reflect that change. In addition, we revised the guidance 
to provide more detailed recommendations if a manufacturer includes 
proprietary information in its citizen petition submitted in accordance 
with Sec.  106.96(i)(3). Furthermore, we made other edits so that the 
language in the guidance corresponds more closely to that used in the 
final rule. The guidance announced in this document finalizes the draft 
guidance dated February 2014.

II. Paperwork Reduction Act of 1995

    This guidance refers to existing regulations in part 10 (21 CFR 
part 10) as well as the final rule, ``Current Good Manufacturing 
Practices, Quality Control Procedures, Quality Factors, Notification 
Requirements, and Records and Reports, for Infant Formula,'' published 
elsewhere in this issue of the Federal Register, which amends parts 106 
and 107 (21 CFR parts 106 and 107). The collection of information in 
part 10 has been approved under OMB control number 0910-0183. The 
collections of information in parts 106 and 107 have been approved 
under OMB control number 0910-0256. These collections of information 
amended by the final rule are subject to review by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3520). The Information Collection Request for the final 
rule is currently under review.

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 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 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: June 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13386 Filed 6-9-14; 8:45 am]
BILLING CODE 4160-01-P
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