Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition), 74671-74672 [2012-30328]

Download as PDF Federal Register / Vol. 77, No. 242 / Monday, December 17, 2012 / Notices Congressional Record).1 This draft guidance addresses one of these goals with the creation of a guidance document that addresses enriched trial designs. The guidance defines and discusses three enrichment strategies: Decreasing heterogeneity, predictive enrichment, and prognostic enrichment. The guidance also discusses general clinical trial design considerations, provides examples of potential clinical trial designs, and discusses regulatory considerations when using enrichment strategies. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on clinical trial designs employing enrichment strategies to support approval of human drugs and biological products. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. 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. III. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https://www.fda. gov/BiologicsBloodVaccines/Guidance ComplianceRegulatoryInformation/ default.htm, https://www.fda.gov/ MedicalDevices/DeviceRegulationand Guidance/GuidanceDocuments/ default.htm, or https:// www.regulations.gov. Dated: November 20, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–30274 Filed 12–14–12; 8:45 am] srobinson on DSK4SPTVN1PROD with BILLING CODE 4160–01–P 1 See ‘‘Section A: PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2008 Through 2012’’ (https://www.fda.gov/For Industry/UserFees/PrescriptionDrugUserFee/ ucm119243.htm). VerDate Mar<15>2010 16:21 Dec 14, 2012 Jkt 229001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–D–1002] Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Questions and Answers Regarding Food Facility Registration (Fifth Edition).’’ The guidance provides updated information pertaining to registration of human and animal food facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA) on January 4, 2011. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit electronic comments on the guidance to https:// www.regulations.gov. Submit written comments on the guidance to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the guidance to the Office of Compliance, Division of Field Programs and Guidance, Center for Food Safety and Applied Nutrition (HFS– 615), 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. FOR FURTHER INFORMATION CONTACT: Amy Barringer, Center for Food Safety and Applied Nutrition (HFS–615), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–1988. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Questions and Answers Regarding Food Facility Registration (Fifth Edition),’’ which replaces the fourth edition of a guidance entitled ‘‘Questions and Answers Regarding Registration of Food Facilities (Edition PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 74671 4)’’ issued in August 2004. The guidance provides updated information pertaining to the registration of food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States. On October 10, 2003, FDA issued an interim final rule (68 FR 58894) to implement amendments to the FD&C Act made by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Public Law 107–188). Section 415 of the FD&C Act (21 U.S.C. 350d) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA by December 12, 2003. This guidance was developed to answer frequently asked questions relating to the registration requirements of section 415. Section 102 of FSMA (Pub. L. 111– 353), enacted on January 4, 2011, amended section 415 of the FD&C Act, in relevant part, to require facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States to submit additional registration information to FDA. This revised edition of the guidance includes new information relating to the FSMA amendments to section 415. The first edition of this document was issued as level 2 guidance under § 10.115 (21 CFR 10.115) and was made available on FDA’s Web site on December 4, 2003. The second, third, and fourth editions of this document were issued as level 1 guidance documents under § 10.115 and were made available on FDA’s Web site on January 12, 2004, February 17, 2004, and August 2004, respectively. This revision (fifth edition) is being issued as a level 1 guidance and includes questions and answers relating to the FSMA amendments to section 415 of the FD&C Act. In addition, the guidance provides non-substantive revisions to clarify, delete, and renumber the questions and answers in edition 4. This guidance is being issued consistent with FDA’s good guidance practices regulation § 10.115 as a level 1 guidance. The Agency will accept comments at any time, but it is implementing this guidance immediately, in accordance with § 10.115(g)(2) because the Agency has determined that prior public participation is not feasible or appropriate. E:\FR\FM\17DEN1.SGM 17DEN1 74672 Federal Register / Vol. 77, No. 242 / Monday, December 17, 2012 / Notices The guidance represents the Agency’s current thinking on food facility registration. 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 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 either https:// www.fda.gov/FoodGuidances or https:// www.regulations.gov. Always access an FDA document using the FDA Web site listed previously to find the most current version of the guidance. This guidance refers to previously approved collections of information found in FDA regulations and section 415 of the FD&C Act. These collections of information 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 collections of information in §§ 1.230 through 1.235 and section 415 of the FD&C Act have been approved under OMB control number 0910–0502. Dated: December 12, 2012. Leslie Kux, Assistant Commissioner for Policy. III. Comments Ag-Mark, Incorporated, et al.; Proposal To Withdraw Approval of New Animal Drug Applications; Opportunity for a Hearing Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see ADDRESSES) or electronic comments to https:// www.regulations.gov. 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 [FR Doc. 2012–30328 Filed 12–14–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–1167] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an opportunity to request a hearing on the Agency’s proposal to withdraw approval of 19 new animal drug applications SUMMARY: (NADAs) and 1 abbreviated new animal drug application (ANADA) from multiple sponsors. The basis for the proposal is that the sponsors have repeatedly failed to file required periodic reports for these applications. DATES: Submit written requests for a hearing by January 16, 2013; submit data and information in support of the hearing request by February 15, 2013. ADDRESSES: Requests for a hearing, supporting data, and other comments are to be identified with Docket No. FDA–2012–N–1167 and submitted to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Vernon Toelle, Center for Veterinary Medicine (HFV–234), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276–9238, email: vernon.toelle@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The holders of approved applications to market new animal drugs are required to submit annual reports to FDA concerning each of their approved applications in accordance with § 514.80 (21 CFR 514.80). The holders of the approved applications listed in table 1 of this document have failed to submit the required annual reports and have not responded to the Agency’s repeated requests for submission of the reports including, in all cases, a request by certified mail. TABLE 1—APPROVED NADAS AND ANADAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN MADE Trade name (drug) Sponsor 009–252 .......... FUMIDIL B (bicyclohexylammonium fumagillin) .......... 034–601 .......... SYNCHRO–MATE (flurogestone acetate) .................. 039–284 .......... 040–920 .......... Swisher Super Broiler 300–108 (amprolium, ethopabate, bacitracin zinc, and roxarsone). Chick Grower-Developer Fortified (amprolium) ........... 094–223 .......... Canine Worm Caps (n-butyl chloride) ......................... 098–429 .......... Medic-Meal-T Premix (tylosin phosphate) ................... 098–639 .......... 106–507 .......... TYLAN Sulfa-G (tylosin phosphate and sulfamethazine). TYLAN 10 (tylosin phosphate) .................................... 110–044 .......... PRO–TONE Plus Pak GF T–1 (tylosin phosphate) .... 117–688 .......... srobinson on DSK4SPTVN1PROD with NADA/ANADA No. Dichlorophene & Toluene Capsules ............................ 120–614 .......... TYLAN Sulfa-G (tylosin phosphate and sulfamethazine). Pet-Worm-Caps (dichlorophene and toluene) ............. Mid-Continent Agrimarketing, Inc., 8833 Quivira Rd., Overland Park, KS 66214. G. D. Searle LLC, 4901 Searle Pkwy., Skokie, IL 60077. Swisher Feed Division, William Davies Co., Inc., P.O. Box 578, Danville, IL 61832. Honeggers and Co., Inc., 201 W. Locust St., Fairbury, IL 61739. K. C. Pharmacal, Inc., 8345 Melrose Dr., Lenexa, KS 66214. J. C. Feed Mills, 1050 Sheffield, P.O. Box 224, Waterloo, IA 50704. Bioproducts, Inc., 320 Springside Dr., Suite 300, Fairlawn, OH 44333–2435. Custom Feed Blenders Corp., 540 Hawkeye Ave., Fort Dodge, IA 50501. Peavey Co., 730 Second Ave. South, Minneapolis, MN 55402. Texas Vitamin Co., P.O. Box 18417, 10695 Aledo St., Dallas, TX 57218. Webel Feeds, Inc., R.R. 3, Pittsfield, IL 62363 ........... 120–671 .......... 121–147 .......... 122–522 .......... VerDate Mar<15>2010 Nutra-Mix TYLAN (tylosin phosphate) ......................... TYLAN Sulfa-G (tylosin phosphate and sulfamethazine). 16:21 Dec 14, 2012 Jkt 229001 PO 00000 Frm 00040 Fmt 4703 Citation in 21 CFR K. C. Pharmacal, Inc., 8345 Melrose Dr., Lenexa, KS 66214. Ag-Mark, Inc., P.O. Box 127, Teachey, NC 28464 ..... Custom Feed Blenders Corp., 540 Hawkeye Ave., Fort Dodge, IA 50501. Sfmt 4703 E:\FR\FM\17DEN1.SGM 17DEN1 520.182 529.1003 558.58 Not codified 520.260 558.625 558.630 558.625 558.625 520.580 558.630 520.580 558.625 558.630

Agencies

[Federal Register Volume 77, Number 242 (Monday, December 17, 2012)]
[Notices]
[Pages 74671-74672]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30328]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-1002]


Guidance for Industry: Questions and Answers Regarding Food 
Facility Registration (Fifth Edition)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Questions and 
Answers Regarding Food Facility Registration (Fifth Edition).'' The 
guidance provides updated information pertaining to registration of 
human and animal food facilities under the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act), as amended by the FDA Food Safety 
Modernization Act (FSMA) on January 4, 2011.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments on the guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit written 
requests for single copies of the guidance to the Office of Compliance, 
Division of Field Programs and Guidance, Center for Food Safety and 
Applied Nutrition (HFS-615), 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.

FOR FURTHER INFORMATION CONTACT: Amy Barringer, Center for Food Safety 
and Applied Nutrition (HFS-615), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-1988.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Questions and Answers Regarding Food Facility Registration 
(Fifth Edition),'' which replaces the fourth edition of a guidance 
entitled ``Questions and Answers Regarding Registration of Food 
Facilities (Edition 4)'' issued in August 2004. The guidance provides 
updated information pertaining to the registration of food facilities 
that manufacture, process, pack, or hold food for human or animal 
consumption in the United States.
    On October 10, 2003, FDA issued an interim final rule (68 FR 58894) 
to implement amendments to the FD&C Act made by the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002 (the 
Bioterrorism Act) (Public Law 107-188). Section 415 of the FD&C Act (21 
U.S.C. 350d) requires domestic and foreign facilities that manufacture, 
process, pack, or hold food for human or animal consumption in the 
United States to register with FDA by December 12, 2003. This guidance 
was developed to answer frequently asked questions relating to the 
registration requirements of section 415.
    Section 102 of FSMA (Pub. L. 111-353), enacted on January 4, 2011, 
amended section 415 of the FD&C Act, in relevant part, to require 
facilities engaged in manufacturing, processing, packing, or holding 
food for consumption in the United States to submit additional 
registration information to FDA. This revised edition of the guidance 
includes new information relating to the FSMA amendments to section 
415.
    The first edition of this document was issued as level 2 guidance 
under Sec.  10.115 (21 CFR 10.115) and was made available on FDA's Web 
site on December 4, 2003. The second, third, and fourth editions of 
this document were issued as level 1 guidance documents under Sec.  
10.115 and were made available on FDA's Web site on January 12, 2004, 
February 17, 2004, and August 2004, respectively. This revision (fifth 
edition) is being issued as a level 1 guidance and includes questions 
and answers relating to the FSMA amendments to section 415 of the FD&C 
Act. In addition, the guidance provides non-substantive revisions to 
clarify, delete, and renumber the questions and answers in edition 4.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation Sec.  10.115 as a level 1 guidance. The Agency 
will accept comments at any time, but it is implementing this guidance 
immediately, in accordance with Sec.  10.115(g)(2) because the Agency 
has determined that prior public participation is not feasible or 
appropriate.

[[Page 74672]]

    The guidance represents the Agency's current thinking on food 
facility registration. 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

    This guidance refers to previously approved collections of 
information found in FDA regulations and section 415 of the FD&C Act. 
These collections of information 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 collections of information in Sec. Sec.  
1.230 through 1.235 and section 415 of the FD&C Act have been approved 
under OMB control number 0910-0502.

III. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to https://www.regulations.gov. 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 
either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. 
Always access an FDA document using the FDA Web site listed previously 
to find the most current version of the guidance.

    Dated: December 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30328 Filed 12-14-12; 8:45 am]
BILLING CODE 4160-01-P
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