Questions and Answers Regarding Food Facility Registration (Sixth Edition); Guidance for Industry; Availability, 68810-68812 [2014-27290]

Download as PDF 68810 Federal Register / Vol. 79, No. 223 / Wednesday, November 19, 2014 / Proposed Rules comments will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket. Availability of NPRM’s An electronic copy of this document may be downloaded through the Internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA’s Web page at http:// www.faa.gov/airports_airtraffic/air_ traffic/publications/airspace_ amendments/. You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined during normal business hours at the Northwest Mountain Regional Office of the Federal Aviation Administration, Air Traffic Organization, Western Service Center, Operations Support Group, 1601 Lind Avenue SW., Renton, WA 98057. Persons interested in being placed on a mailing list for future NPRM’s should contact the FAA’s Office of Rulemaking, (202) 267–9677, for a copy of Advisory Circular No. 11–2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure. rljohnson on DSK3VPTVN1PROD with PROPOSALS The Proposal The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by establishing Class E en route domestic airspace extending upward from 1,200 feet above the surface at Spokane, WA. This action would contain aircraft while in IFR conditions under control of Seattle ARTCC by vectoring aircraft from en route airspace to terminal areas, therefore enhancing the safety and management of IFR operations within the NAS. Class E airspace designations are published in paragraph 6006, of FAA Order 7400.9Y, dated August 6, 2014, and effective September 15, 2014, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in this Order. VerDate Sep<11>2014 14:17 Nov 18, 2014 Jkt 235001 The FAA has determined this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this proposed regulation; (1) Is not a ‘‘significant regulatory action’’ under Executive Order 12866; (2) is not a ‘‘significant rule’’ under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified this proposed rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. The FAA’s authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes the authority for the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency’s authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This proposed regulation is within the scope of that authority as it would establish controlled airspace at Spokane, WA. This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1E, ‘‘Environmental Impacts: Policies and Procedures’’ prior to any FAA final regulatory action. § 71.1 [Amended] 2. The incorporation by reference in 14 CFR 71.1 of the Federal Aviation Administration Order 7400.9Y, Airspace Designations and Reporting Points, dated August 6, 2014, and effective September 15, 2014, is amended as follows: ■ Paragraph 6006 Airspace Areas. En Route Domestic * * * * Issued in Seattle, Washington, on 11/06/ 2014. Christopher Ramirez, Acting Manager, Operations Support Group, Western Service Center. [FR Doc. 2014–27318 Filed 11–18–14; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 10 [Docket No. FDA–2012–D–1002] Questions and Answers Regarding Food Facility Registration (Sixth Edition); Guidance for Industry; Availability Food and Drug Administration, List of Subjects in 14 CFR Part 71 Airspace, Incorporation by reference, Navigation (air). AGENCY: The Proposed Amendment Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows: SUMMARY: PART 71—DESIGNATION OF CLASS A, B, C, D AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for 14 CFR part 71 continues to read as follows: ■ Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– 1963 Comp., p. 389. PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 * ANM WA E6 Spokane, WA [New] Spokane, WA That airspace extending upward from 1,200 feet above the surface within an area bounded by a line beginning at lat. 45°49′52″ N., long. 118°02′34″ W.; to lat. 44°50′06″ N., long. 117°05′33″ W.; to lat. 45°50′00″ N., long. 115°45′00″ W.; to lat. 46°02′00″ N., long. 115°45′00″ W.; to lat. 48°24′00″ N., long. 115°44′57″ W.; to lat. 49°00′00″ N., long. 115°30′00″ W.; to lat. 49°00′00″ N., long. 120°00′00″ W.; to lat. 46°23′19″ N., long. 121°07′50″ W.; to lat. 45°09′13″ N., long. 119°01′43″ W.; thence to the point of beginning. HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ‘‘Questions and Answers Regarding Food Facility Registration (Sixth Edition).’’ The guidance includes one additional question and answer regarding FDA’s policy regarding food facility registration for farms that also pack or hold raw agricultural commodities grown on a farm under different ownership in light of other ongoing FDA Food Safety Modernization Act (FSMA) rulemakings. E:\FR\FM\19NOP1.SGM 19NOP1 Federal Register / Vol. 79, No. 223 / Wednesday, November 19, 2014 / Proposed Rules Submit either electronic or written comments on FDA guidances at any time. ADDRESSES: Submit electronic comments on the guidance to http:// 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. 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 document. 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: DATES: rljohnson on DSK3VPTVN1PROD with PROPOSALS I. Background We are announcing the availability of a guidance for industry entitled ‘‘Questions and Answers Regarding Food Facility Registration (Sixth Edition) available on FDA’s Web site at http://www.fda.gov/Food/ GuidanceRegulation/ GuidanceDocumentsRegulatory Information/ucm331959.htm.’’ We are issuing this guidance consistent with our good guidance practices (GGP) regulation (§ 10.115 (21 CFR 10.115)). In accordance with § 10.115(g)(2), we are implementing this guidance without prior public comment because we have determined that prior public participation is not feasible or appropriate. The guidance represents a less burdensome policy consistent with the public health. Although this guidance document is immediately in effect, FDA will accept comments at any time. Section 102 of FSMA (Pub. L. 111– 353), signed into law on January 4, 2011, amends section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) (the FD&C Act) regarding requirements for food facility registration. Further, section 102(a)(3) of FSMA amends section 415 of the FD&C Act to provide that food facilities required to register with FDA must renew their registrations with FDA every 2 years, between October 1 and December 31 of each even-numbered VerDate Sep<11>2014 14:17 Nov 18, 2014 Jkt 235001 year, by submitting registrations renewals to FDA. In addition to amending section 415 of the FD&C Act, FSMA also amended the FD&C Act such that section 415 functions in connection with other food safety provisions. For instance, FSMA added section 418 of the FD&C Act (21 U.S.C. 350g), which establishes certain preventive control requirements for food facilities that are required to register under section 415 of the FD&C Act. In general, section 418(a) of the FD&C Act requires the owner, operator, or agent in charge of a ‘‘facility’’ to evaluate the hazards that could affect food manufactured, processed, packed, or held by such facility, identify and implement preventive controls, monitor the performance of those controls, and maintain records of the monitoring. The term ‘‘facility’’ is defined in section 418(o)(2) of the FD&C Act as ‘‘a domestic facility or a foreign facility that is required to register under section 415.’’ As part of the rulemaking to implement section 418 of the FD&C Act, on September 29, 2014 (79 FR 58524), we published a supplemental notice of proposed rulemaking in the Federal Register, ‘‘Current Good Manufacturing Practice and Hazard Analysis and RiskBased Preventive Controls for Human Food’’ (preventive controls for human food). In that supplemental proposed rule, we proposed, inter alia, certain changes to the definition of the term ‘‘farm’’ in 21 CFR 1.227 (§ 1.227). If implemented, these changes would impact food facility registration because the food facility registration requirements of section 415 of the FD&C Act do not apply to an establishment that meets the definition of ‘‘farm.’’ The current definition of a ‘‘farm’’ under § 1.227 describes a farm in relevant part as a facility devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. Although that definition of ‘‘farm’’ then provides that farms also pack or hold food, it limits facilities that fall within the definition of ‘‘farm’’ to those that pack or hold food grown, raised, or consumed on that farm or another farm under the same ownership. Thus, under the current definition, an establishment that is devoted to the growing and harvesting of crops, but also packs and holds food not grown or raised on that farm or on another farm under the same ownership, would fall outside the definition of ‘‘farm’’ and be required to register as a food facility. In the supplemental notice of proposed rulemaking for preventive controls for human food, FDA proposed to revise the ‘‘farm’’ definition in relevant part so PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 68811 that it would no longer limit establishments that fall within the ‘‘farm’’ definition to those that pack or hold food grown, raised, or consumed on that farm or another farm under the same ownership. Under the revised ‘‘farm’’ definition, an establishment devoted to the growing of crops, the raising of animals, or both, would remain within the ‘‘farm’’ definition (and, thus, not be subject to the FD&C Act section 415 registration regulations) even if it packs and holds raw agricultural commodities grown on another farm. In light of this ongoing rulemaking, we are announcing our policy regarding food facility registration for farms that also pack or hold raw agricultural commodities grown on a farm under different ownership and that would no longer be required to register if the proposed amendments to the ‘‘farm’’ definition are finalized as proposed. Under this policy, as discussed in the guidance, FDA does not intend to prioritize enforcing the registration requirement for such establishments. This policy is a less burdensome policy consistent with the public health. FDA intends to make further updates to this guidance once certain FSMA rulemakings are final in order to make sure questions and answers, key terms, and definitions are consistent and accurate with regard to the registration of food facility requirements. 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 alternative 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 §§ 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 electronic comments regarding this guidance to http://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 E:\FR\FM\19NOP1.SGM 19NOP1 68812 Federal Register / Vol. 79, No. 223 / Wednesday, November 19, 2014 / Proposed Rules 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 http:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Regulatory Information/Guidances/default.htm or http://www.regulations.gov. Always access an FDA guidance document by using FDA’s Web site listed in the previous sentence to find the most current version of the guidance. Dated: November 13, 2014. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2014–27290 Filed 11–18–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF EDUCATION 34 CFR Chapter II [Docket ID ED–2014–OII–0019; CFDA Number: 84.282A] Proposed Priorities, Requirements, Definitions, and Selection Criteria— Charter Schools Program Grants to State Educational Agencies Office of Innovation and Improvement, Department of Education. ACTION: Proposed priorities, requirements, definitions, and selection criteria. AGENCY: The Assistant Deputy Secretary for Innovation and Improvement proposes priorities, requirements, definitions, and selection criteria under the Charter Schools Program (CSP) Grants to State educational agencies (SEAs). The Assistant Deputy Secretary may use one or more of these priorities, requirements, definitions, and selection criteria for competitions in fiscal year (FY) 2015 and later years. We take this action in order to support the development of high-quality charter schools throughout the Nation by strengthening several components of this program, including grantee accountability; accountability and oversight for authorized public chartering agencies; and support to educationally disadvantaged students. DATES: We must receive your comments on or before January 5, 2015. ADDRESSES: Submit your comments through the Federal eRulemaking Portal or via postal mail, commercial delivery, or hand delivery. We will not accept rljohnson on DSK3VPTVN1PROD with PROPOSALS SUMMARY: VerDate Sep<11>2014 14:17 Nov 18, 2014 Jkt 235001 comments submitted by fax or by email or those submitted after the comment period. To ensure that we do not receive duplicate copies, please submit your comments only once. In addition, please include the Docket ID at the top of your comments. • Federal eRulemaking Portal: Go to www.regulations.gov to submit your comments electronically. Information on using Regulations.gov, including instructions for accessing agency documents, submitting comments, and viewing the docket, is available on the site under ‘‘Are you new to the site?’’ • Postal Mail, Commercial Delivery, or Hand Delivery: If you mail or deliver your comments, address them to Stefan Huh, U.S. Department of Education, 400 Maryland Avenue SW., Room 4W230, Washington, DC 20202–5970. Privacy Note: The Department’s policy is to make all comments received from members of the public available for public viewing in their entirety on the Federal eRulemaking Portal at www.regulations.gov. Therefore, commenters should be careful to include in their comments only information that they wish to make publicly available. FOR FURTHER INFORMATION CONTACT: Jonathan Bettis, U.S. Department of Education, 400 Maryland Avenue SW., Room 4W242, Washington, DC 20202– 5970. Telephone: (202) 453–6533 or by email: charter.schools@ed.gov. If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1–800–877– 8339. SUPPLEMENTARY INFORMATION: Executive Summary Purpose of This Regulatory Action: The Assistant Deputy Secretary for Innovation and Improvement proposes priorities, requirements, definitions, and selection criteria for CSP Grants to SEAs. The Assistant Deputy Secretary may use one or more of these priorities, requirements, definitions, and selection criteria for competitions in FY 2015 and later years. We take this action in order to support the development of highquality charter schools throughout the Nation by strengthening several components of the program, including grantee accountability, accountability and oversight for authorized public chartering agencies, and support to educationally disadvantaged students. Summary of the Major Provisions of This Regulatory Action: As noted above, the Assistant Deputy Secretary proposes this regulatory action to achieve three main goals. PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 The first goal is greater accountability for SEAs’ use of CSP funds; the proposed priorities, requirements, definitions, and selection criteria would increase the likelihood that CSP funds are directed toward the creation of highquality charter schools. Specifically, in order to address the proposed selection criteria, the SEA would be asked to explain how charter schools fit into the State’s broader education reform strategy. In addition, these proposed selection criteria would clarify how the SEA should manage and report on project performance. Proposed selection criteria (a) (‘‘State-Level Strategy’’) and (b) (‘‘Policy Context for Charter Schools’’) would address the SEA’s strategy for incorporating charter schools into the State’s broader effort to improve student outcomes and how the policy context supports this goal. Proposed selection criterion (c) (‘‘Past Performance’’) would assess the performance of charter schools in the applicant’s State over the past five years. Proposed selection criterion (e) (‘‘Vision for Growth and Accountability’’) would address the SEA’s vision for measuring and reporting on charter school performance, cultivating the growth of new high-quality charter schools, and promoting rigorous accountability for charter school performance. Proposed selection criterion (f) (‘‘Dissemination of Information and Best Practices’’) would help ensure that the SEA has a plan for disseminating information about charter schools and best practices in successful charter schools. Proposed selection criterion (h) (‘‘Management Plan and Theory of Action’’) and the proposed logic model application requirement would require the SEA to provide a logic model that describes how its CSP funds would be linked to the achievement of specific measurable outcomes and performance measures that allow the SEA to track and evaluate its project’s performance. Proposed selection criterion (i) (‘‘Project Design’’) would solicit information on the mechanics of the charter school subgrant program the SEA plans to implement with CSP funds. In addition to the selection criteria discussed above, proposed priority 4 (‘‘SEAs That Have Never Received A CSP Grant’’) would promote the first goal of greater accountability by supporting the growth of high-quality charter school sectors in States that have not received CSP funding in the past, thereby creating new systems of supports and increasing the funding available for high-quality charter schools in new regions. E:\FR\FM\19NOP1.SGM 19NOP1

Agencies

[Federal Register Volume 79, Number 223 (Wednesday, November 19, 2014)]
[Proposed Rules]
[Pages 68810-68812]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-27290]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 10

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


Questions and Answers Regarding Food Facility Registration (Sixth 
Edition); Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a guidance for industry entitled ``Questions and 
Answers Regarding Food Facility Registration (Sixth Edition).'' The 
guidance includes one additional question and answer regarding FDA's 
policy regarding food facility registration for farms that also pack or 
hold raw agricultural commodities grown on a farm under different 
ownership in light of other ongoing FDA Food Safety Modernization Act 
(FSMA) rulemakings.

[[Page 68811]]


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

ADDRESSES: Submit electronic comments on the guidance to http://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. 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 document.

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

    We are announcing the availability of a guidance for industry 
entitled ``Questions and Answers Regarding Food Facility Registration 
(Sixth Edition) available on FDA's Web site at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm331959.htm.'' We are issuing this guidance consistent with our good 
guidance practices (GGP) regulation (Sec.  10.115 (21 CFR 10.115)). In 
accordance with Sec.  10.115(g)(2), we are implementing this guidance 
without prior public comment because we have determined that prior 
public participation is not feasible or appropriate. The guidance 
represents a less burdensome policy consistent with the public health. 
Although this guidance document is immediately in effect, FDA will 
accept comments at any time.
    Section 102 of FSMA (Pub. L. 111-353), signed into law on January 
4, 2011, amends section 415 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 350d) (the FD&C Act) regarding requirements for food 
facility registration. Further, section 102(a)(3) of FSMA amends 
section 415 of the FD&C Act to provide that food facilities required to 
register with FDA must renew their registrations with FDA every 2 
years, between October 1 and December 31 of each even-numbered year, by 
submitting registrations renewals to FDA.
    In addition to amending section 415 of the FD&C Act, FSMA also 
amended the FD&C Act such that section 415 functions in connection with 
other food safety provisions. For instance, FSMA added section 418 of 
the FD&C Act (21 U.S.C. 350g), which establishes certain preventive 
control requirements for food facilities that are required to register 
under section 415 of the FD&C Act. In general, section 418(a) of the 
FD&C Act requires the owner, operator, or agent in charge of a 
``facility'' to evaluate the hazards that could affect food 
manufactured, processed, packed, or held by such facility, identify and 
implement preventive controls, monitor the performance of those 
controls, and maintain records of the monitoring. The term ``facility'' 
is defined in section 418(o)(2) of the FD&C Act as ``a domestic 
facility or a foreign facility that is required to register under 
section 415.''
    As part of the rulemaking to implement section 418 of the FD&C Act, 
on September 29, 2014 (79 FR 58524), we published a supplemental notice 
of proposed rulemaking in the Federal Register, ``Current Good 
Manufacturing Practice and Hazard Analysis and Risk-Based Preventive 
Controls for Human Food'' (preventive controls for human food). In that 
supplemental proposed rule, we proposed, inter alia, certain changes to 
the definition of the term ``farm'' in 21 CFR 1.227 (Sec.  1.227). If 
implemented, these changes would impact food facility registration 
because the food facility registration requirements of section 415 of 
the FD&C Act do not apply to an establishment that meets the definition 
of ``farm.'' The current definition of a ``farm'' under Sec.  1.227 
describes a farm in relevant part as a facility devoted to the growing 
and harvesting of crops, the raising of animals (including seafood), or 
both. Although that definition of ``farm'' then provides that farms 
also pack or hold food, it limits facilities that fall within the 
definition of ``farm'' to those that pack or hold food grown, raised, 
or consumed on that farm or another farm under the same ownership. 
Thus, under the current definition, an establishment that is devoted to 
the growing and harvesting of crops, but also packs and holds food not 
grown or raised on that farm or on another farm under the same 
ownership, would fall outside the definition of ``farm'' and be 
required to register as a food facility. In the supplemental notice of 
proposed rulemaking for preventive controls for human food, FDA 
proposed to revise the ``farm'' definition in relevant part so that it 
would no longer limit establishments that fall within the ``farm'' 
definition to those that pack or hold food grown, raised, or consumed 
on that farm or another farm under the same ownership. Under the 
revised ``farm'' definition, an establishment devoted to the growing of 
crops, the raising of animals, or both, would remain within the 
``farm'' definition (and, thus, not be subject to the FD&C Act section 
415 registration regulations) even if it packs and holds raw 
agricultural commodities grown on another farm.
    In light of this ongoing rulemaking, we are announcing our policy 
regarding food facility registration for farms that also pack or hold 
raw agricultural commodities grown on a farm under different ownership 
and that would no longer be required to register if the proposed 
amendments to the ``farm'' definition are finalized as proposed. Under 
this policy, as discussed in the guidance, FDA does not intend to 
prioritize enforcing the registration requirement for such 
establishments. This policy is a less burdensome policy consistent with 
the public health. FDA intends to make further updates to this guidance 
once certain FSMA rulemakings are final in order to make sure questions 
and answers, key terms, and definitions are consistent and accurate 
with regard to the registration of food facility requirements.
    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 alternative 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 electronic comments regarding 
this guidance to http://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

[[Page 68812]]

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 http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/RegulatoryInformation/Guidances/default.htm 
or http://www.regulations.gov. Always access an FDA guidance document 
by using FDA's Web site listed in the previous sentence to find the 
most current version of the guidance.

    Dated: November 13, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27290 Filed 11-18-14; 8:45 am]
BILLING CODE 4164-01-P