Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals; Extension of Comment Period, 6111-6112 [2014-02111]

Download as PDF Federal Register / Vol. 79, No. 22 / Monday, February 3, 2014 / Proposed Rules certificated in any category, all serial numbers. (d) Subject Air Transport Association (ATA) of America Code 52, Doors. (e) Reason This AD was prompted by reports that the bracket of the rod in the carbon fiber reinforced plastic (CFRP) main landing gear (MLG) outboard door had detached. In addition, we received reports of broken recessed heads on titanium attachment bolts of the operating rod brackets on the modified CFRP MLG outboard doors. We are issuing this AD to detect and correct the affected MLG from moving to the down and locked position, which could result in MLG collapse during landing or roll-out, and consequent damage to the airplane and injury to passengers. (f) Compliance Comply with this AD within the compliance times specified, unless already done. (g) Inspection Within 9 months after the effective date of this AD, do a detailed inspection of the CFRP MLG outboard door for play and cracks in the recessed countersunk heads of the operating rod bracket attachment bolts, in accordance with Part 1 of the Accomplishment Instructions of Fokker Service Bulletin SBF100–52–090, dated November 17, 2011, including Fokker Manual Change Notification F100–147, dated October 28, 2011, and Fokker Service Bulletin Change Notification SBF100–52–090101, dated January 24, 2012. mstockstill on DSK4VPTVN1PROD with PROPOSALS (h) Corrective Action If, during the inspection required by paragraph (g) of this AD, any play or crack is found in any countersunk bolt head, and the configuration deviation list (CDL) item 52–07 cannot be applied: Before further flight, replace the bolt with a new bolt, in accordance with the Accomplishment Instructions of Fokker Service Bulletin SBF100–52–090, dated November 17, 2011, including Fokker Manual Change Notification F100–147, dated October 28, 2011, and Fokker Service Bulletin Change Notification SBF100–52–090101, dated January 24, 2012. (i) Modification Prior to CFRP Door Installation At the applicable time specified in paragraph (i)(1) or (i)(2) of this AD: Modify the CFRP MLG outboard doors and attachment to the MLG, in accordance with Part 2 of the Accomplishment Instructions of Fokker Service Bulletin SBF100–52–090, dated November 17, 2011, including Fokker Manual Change Notification F100–147, dated October 28, 2011, and Fokker Service Bulletin Change Notification SBF100–52– 090101, dated January 24, 2012. Accomplishing the modification in this paragraph terminates the inspection required by paragraph (g) of this AD. (1) For airplanes on which a CFRP MLG outboard door is installed as of the effective VerDate Mar<15>2010 16:26 Jan 31, 2014 Jkt 232001 date of this AD: Do the modification within 24 months after the effective date of this AD. (2) For airplanes on which an aluminum door is installed as of the effective date of this AD: Do the modification prior to the installation of the CFRP MLG outboard door. Note 1 to paragraph (i) of this AD: The aluminum MLG outboard doors and the CFRP MLG outboard doors are two-way interchangeable. (j) Parts Installation Prohibition As of the effective date of this AD, do not install on any airplane a MLG outboard door having part number (P/N) D13310–401 through –418 or any MLG outboard door assembly having P/N D13312–401 through –410. Note 2 to paragraph (j) of this AD: Civil Aviation Authority-Netherlands (CAA–NL) AD NL–2006–001 (European Aviation Safety Agency (EASA) approval 2006–002) contains the information on how to modify all spare MLG outboard door assemblies having P/N D13312–401 through –410, to P/N D13312– 7XX standard, as specified in the Accomplishment Instructions of Fokker Component Service Bulletin D13312–52–09, December 12, 2005. (k) Parts Installation Limitation As of the effective date of this AD, do not install on any airplane a P/N D13310–701 through–708 MLG outboard door or a P/N D13312–702 through–711 MLG outboard door assembly, unless the part has been inspected for cracks in the recessed bolt heads, all applicable corrective actions have been done, and the CFRP MLG outboard door has been modified, in accordance with the Accomplishment Instructions of Fokker Component Service Bulletin D13312–52–015, dated November 17, 2011. (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: Tom Rodriguez, Aerospace Engineer, International Branch, ANM–116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057–3356; telephone (425) 227–1137; 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 PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 6111 considered FAA-approved if they were approved by the State of Design Authority (or its delegated agent, or the DAH with a State of Design Authority’s design organization approval). 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. (m) Related Information (1) Refer to Mandatory Continuing Airworthiness Information EASA Airworthiness Directive 2012–0023, dated February 6, 2012, for related information. This MCAI 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–2014–0007. (2) For service information identified in this AD, contact Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130 EL Hoofddorp, the Netherlands; telephone +31 (0)88–6280–350; fax +31 (0)88–6280–111; email technicalservices@fokker.com; Internet https://www.myfokkerfleet.com. You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425–227–1221. Issued in Renton, Washington, on January 22, 2014. Jeffrey E. Duven, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. 2014–02161 Filed 1–31–14; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 16, 225, 500, 507, and 579 [Docket No. FDA–2011–N–0922] RIN 0910–AG10 Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. Proposed rule; extension of comment period. ACTION: The Food and Drug Administration (FDA or we) is extending the comment period for the notice of proposed rulemaking that appeared in the Federal Register of October 29, 2013 (78 FR 64736), entitled ‘‘Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals ’’ and its information collection SUMMARY: E:\FR\FM\03FEP1.SGM 03FEP1 6112 Federal Register / Vol. 79, No. 22 / Monday, February 3, 2014 / Proposed Rules provisions. We are taking this action in response to requests for an extension to allow interested persons more time to comment given that in addition to the proposed preventive control requirements, the proposed current good manufacturing practice (CGMP) requirements are also new to the animal food industry, unlike the human food industry. We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with the comment period for the proposed rule. DATES: FDA is extending the comment period on the proposed rule and its information collection provisions. Submit either electronic or written comments on the proposed rule and the information collection by March 31, 2014. You may submit comments, identified by Docket No. FDA–2011–N– 0922 and/or Regulatory Information Number (RIN) 0910–AG10, by any of the following methods, except that comments on information collection issues under the PRA must be submitted to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB) (see the ‘‘Paperwork Reduction Act of 1995’’ section of this document). ADDRESSES: Electronic Submissions Submit electronic comments in the following way: Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. mstockstill on DSK4VPTVN1PROD with PROPOSALS Written Submissions Submit written submissions in the following ways: Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the Agency name, Docket No. FDA–2011–N–0922, and RIN 0910– AG10 for this rulemaking. All comments received may be posted without change to https://www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the ‘‘Request for Comments’’ heading of the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read background documents or comments received, go to https:// www.regulations.gov, and insert the docket number, found in brackets in the heading of this document, into the VerDate Mar<15>2010 16:26 Jan 31, 2014 Jkt 232001 ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: With regard to the proposed rule: Kim Young, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240– 276–2207. With regard to the information collection: Domini Bean, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400T, Rockville, MD 20850, Domini.Bean@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of October 29, 2013, we published a proposed rule entitled ‘‘Current Good Manufacturing Practice and Hazard Analysis and RiskBased Preventive Controls for Food for Animals’’ with a 120-day comment period on the provisions of the proposed rule and on the information collection provisions that are subject to review by OMB under the PRA (44 U.S.C. 3501–3520). FDA has received requests for an extension of the comment period on the proposed rule. The requests conveyed concern that the current 120-day comment period does not allow time to develop a meaningful response to the proposed rule because, unlike the human food industry, in addition to the proposed preventive controls, the proposed CGMPs are new to the animal food industry. The requests also stated an extended comment period would allow interested persons an opportunity to consider the interrelationship between this proposed rule and the proposed rules entitled ‘‘Foreign Supplier Verification Programs for Importers of Food for Humans and Animals’’ (78 FR 45729, July 29, 2013) and ‘‘Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications’’ (78 FR 45782, July 29, 2013). FDA has considered the requests and is granting an extension of the comment period to March 31, 2014, for the ‘‘Current Good Manufacturing Practice and Hazard Analysis and RiskBased Preventive Controls for Food for Animals’’ proposed rule to allow interested persons additional time to submit comments. We also are extending the comment period for the information collection provisions to March 31, 2014, to make the comment period for the information collection provisions the same as the comment period for the provisions of the PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 proposed rule. To clarify, FDA is requesting comment on all issues raised by the proposed rule. II. Paperwork Reduction Act of 1995 Interested persons may either submit electronic comments regarding the information collection to oira_ submission@omb.eop.gov or fax written comments to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285. All comments should be identified with the title ‘‘Current Good Manufacturing Practice and Hazard Analysis and RiskBased Preventive Controls for Food for Animals.’’ III. Request for Comments Interested persons may submit either electronic comments regarding the proposed rule 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. Dated: January 28, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–02111 Filed 1–31–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 17 [Docket No. FDA–2014–N–0113] Maximum Civil Money Penalty Amounts; Civil Money Penalty Complaints AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. The Food and Drug Administration (FDA) is publishing this companion proposed rule to the direct final rule, issuing a new regulation to adjust for inflation the maximum civil money penalty (CMP) amounts for the various CMP authorities within our jurisdiction and to amend the process for initiating certain CMP administrative actions. We are taking these actions to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 SUMMARY: E:\FR\FM\03FEP1.SGM 03FEP1

Agencies

[Federal Register Volume 79, Number 22 (Monday, February 3, 2014)]
[Proposed Rules]
[Pages 6111-6112]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02111]


=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16, 225, 500, 507, and 579

[Docket No. FDA-2011-N-0922]
RIN 0910-AG10


Current Good Manufacturing Practice and Hazard Analysis and Risk-
Based Preventive Controls for Food for Animals; Extension of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the notice of proposed rulemaking that appeared in 
the Federal Register of October 29, 2013 (78 FR 64736), entitled 
``Current Good Manufacturing Practice and Hazard Analysis and Risk-
Based Preventive Controls for Food for Animals '' and its information 
collection

[[Page 6112]]

provisions. We are taking this action in response to requests for an 
extension to allow interested persons more time to comment given that 
in addition to the proposed preventive control requirements, the 
proposed current good manufacturing practice (CGMP) requirements are 
also new to the animal food industry, unlike the human food industry.
    We also are taking this action to keep the comment period for the 
information collection provisions associated with the rule consistent 
with the comment period for the proposed rule.

DATES: FDA is extending the comment period on the proposed rule and its 
information collection provisions. Submit either electronic or written 
comments on the proposed rule and the information collection by March 
31, 2014.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0922 and/or Regulatory Information Number (RIN) 0910-AG10, by any of 
the following methods, except that comments on information collection 
issues under the PRA must be submitted to the Office of Information and 
Regulatory Affairs, Office of Management and Budget (OMB) (see the 
``Paperwork Reduction Act of 1995'' section of this document).

Electronic Submissions

    Submit electronic comments in the following way:
    Federal eRulemaking Portal: https://www.regulations.gov. Follow the 
instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
    Mail/Hand delivery/Courier (for paper submissions): Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency 
name, Docket No. FDA-2011-N-0922, and RIN 0910-AG10 for this 
rulemaking. All comments received may be posted without change to 
https://www.regulations.gov, including any personal information 
provided. For additional information on submitting comments, see the 
``Request for Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov, and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: With regard to the proposed rule: Kim 
Young, Center for Veterinary Medicine, Food and Drug Administration, 
7519 Standish Pl., Rockville, MD 20855, 240-276-2207.
    With regard to the information collection: Domini Bean, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400T, Rockville, MD 20850, Domini.Bean@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 29, 2013, we published a 
proposed rule entitled ``Current Good Manufacturing Practice and Hazard 
Analysis and Risk-Based Preventive Controls for Food for Animals'' with 
a 120-day comment period on the provisions of the proposed rule and on 
the information collection provisions that are subject to review by OMB 
under the PRA (44 U.S.C. 3501-3520).
    FDA has received requests for an extension of the comment period on 
the proposed rule. The requests conveyed concern that the current 120-
day comment period does not allow time to develop a meaningful response 
to the proposed rule because, unlike the human food industry, in 
addition to the proposed preventive controls, the proposed CGMPs are 
new to the animal food industry. The requests also stated an extended 
comment period would allow interested persons an opportunity to 
consider the interrelationship between this proposed rule and the 
proposed rules entitled ``Foreign Supplier Verification Programs for 
Importers of Food for Humans and Animals'' (78 FR 45729, July 29, 2013) 
and ``Accreditation of Third-Party Auditors/Certification Bodies to 
Conduct Food Safety Audits and to Issue Certifications'' (78 FR 45782, 
July 29, 2013). FDA has considered the requests and is granting an 
extension of the comment period to March 31, 2014, for the ``Current 
Good Manufacturing Practice and Hazard Analysis and Risk-Based 
Preventive Controls for Food for Animals'' proposed rule to allow 
interested persons additional time to submit comments. We also are 
extending the comment period for the information collection provisions 
to March 31, 2014, to make the comment period for the information 
collection provisions the same as the comment period for the provisions 
of the proposed rule. To clarify, FDA is requesting comment on all 
issues raised by the proposed rule.

II. Paperwork Reduction Act of 1995

    Interested persons may either submit electronic comments regarding 
the information collection to oira_submission@omb.eop.gov or fax 
written comments to the Office of Information and Regulatory Affairs, 
OMB, Attn: FDA Desk Officer, FAX: 202-395-7285. All comments should be 
identified with the title ``Current Good Manufacturing Practice and 
Hazard Analysis and Risk-Based Preventive Controls for Food for 
Animals.''

III. Request for Comments

    Interested persons may submit either electronic comments regarding 
the proposed rule 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.

    Dated: January 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02111 Filed 1-31-14; 8:45 am]
BILLING CODE 4160-01-P

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