81 FR 78526 - Questions and Answers Regarding Food Facility Registration (Seventh Edition); Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 216 (November 8, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 216 (November 8, 2016)
| Page Range | 78526-78528 | |
| FR Document | 2016-26930 |
[Federal Register Volume 81, Number 216 (Tuesday, November 8, 2016)] [Proposed Rules] [Pages 78526-78528] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26930] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1 [Docket No. FDA-2012-D-1002] Questions and Answers Regarding Food Facility Registration (Seventh Edition); Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry.'' This draft guidance contains 15 sections of a multisection guidance intended to provide updated information relating to the food facility registration requirements in the Federal Food, Drug, and Cosmetic Act (the FD&C Act). DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 6, 2017. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2012-D-1002 for the draft guidance for industry entitled ``Questions and Answers Regarding Food Facility Registration (Seventh Edition).'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/ [[Page 78527]] regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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. Submit written requests for single copies of the draft guidance to the Office of Compliance, Division of Field Programs and Guidance, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self- addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance. FOR FURTHER INFORMATION CONTACT: Courtney Buchanan, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2487. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a draft guidance for industry entitled ``Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry.'' We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of the FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations. On October 10, 2003, FDA issued an interim final rule (68 FR 58893) 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) (Pub. L. 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. Section 102 of the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), enacted on January 4, 2011, amended section 415 of the FD&C Act to, among other things, require facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States to submit additional registration information to FDA. Section 102 of FSMA also directed FDA to amend the definition of ``retail food establishment'' in 21 CFR 1.227. On July 14, 2016, FDA issued a final rule (Registration Final Rule) to amend and update FDA's registration regulation and implement the FSMA revisions (81 FR 45912; July 14, 2016). This draft guidance was developed to answer frequently asked questions relating to the registration requirements of section 415 of the FD&C Act. The first edition of the guidance was issued as Level 2 guidance consistent with our good guidance practices regulation (21 CFR 10.115) and was made available on FDA's Web site on December 4, 2003. The second, third, fourth, and fifth editions of the guidance were issued as Level 1 guidance documents under 21 CFR 10.115 and were made available on FDA's Web site on January 12, 2004; February 17, 2004; August 6, 2004; and December 17, 2012, respectively. The sixth edition of the guidance was issued as Level 1 guidance and included one additional question and answer relating to a proposed amendment to the ``farm'' definition in 21 CFR 1.227 (see 79 FR 58523; September 29, 2014). Since publication of the sixth edition of the guidance, we have issued the Registration Final Rule. In addition, we have issued the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food final rule (Preventive Controls for Human Food Final Rule) (80 FR 55908; September 17, 2015) that, among other things, revised the definition of ``farm'' in 21 CFR 1.227. We have also issued the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals final rule (Preventive Controls for Animal Food Final Rule) (80 FR 56169; September 17, 2015). We are issuing a seventh edition of the guidance to add information relating to the Registration Final Rule and the revised ``farm'' definition, as well as to address questions received from stakeholders since publication of the sixth edition. We are reserving two sections in the draft guidance and will issue a revised draft guidance at a later date that includes those reserved sections. The sections that we are announcing are as follows: Section A. Who Must Register? Section D: When Must You Register or Renew Your Registration? Section E: How and Where Do You Register or Renew Your Registration? Section F: What Information is Required in the Registration? Section G: What Optional Items are Included in the Registration? Section H: How and When Do You Update Your Facility's Registration Information? Section I: How and When Do You Cancel Your Facility's Registration Information? Section J: What Other Registration Requirements Apply? Section K: What are the Consequences of Failing to Register, Renew, Update, or Cancel Your Registration? Section L: What Does Assignment of a Registration Number Mean? Section M: Is Food Registration Information Available to the Public? Section N: Waiver Request Section O: General Registration Questions Section P: Suspension of Registration Section Q: Compliance Dates We intend to announce the availability for public comment of the remaining sections of the draft guidance in a revised draft guidance. This edition of the draft guidance also revises information in existing questions and answers, removes some questions and answers, and makes editorial changes (e.g., we reorganized existing questions and answers) to improve clarity. For the revised questions and answers, we are not adding a date indicating when the questions and answers were revised. As in the previous editions, the following indicators are used to help users identify revisions: (1) The guidance is identified as a revision of a previously issued document; (2) the revision date appears on the cover of the guidance; (3) the edition number of the guidance is included in its title; and (4) questions and answers that have been added are identified as such in the body of the guidance. In addition, we indicated certain sections in the draft guidance as ``Reserved.'' II. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/default.htm or http://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance. III. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of [[Page 78528]] Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 1.230 through 1.235 and 21 CFR 1.245 have been approved under OMB control number 0910-0502. Dated: November 3, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-26930 Filed 11-7-16; 8:45 am] BILLING CODE 4164-01-P
![78526 Federal Register / Vol. 81, No. 216 / Tuesday, November 8, 2016 / Proposed Rules
§ 923.85 Procedural requirements of other DEPARTMENT OF HEALTH AND written/paper submission and in the
Federal law. HUMAN SERVICES manner detailed (see ‘‘Written/Paper
(a) NOAA shall determine on a case- Submissions’’ and ‘‘Instructions’’).
by-case basis whether each program Food and Drug Administration
Written/Paper Submissions
change requires NOAA to take
21 CFR Part 1 Submit written/paper submissions as
additional actions under any other follows:
federal requirement described below. [Docket No. FDA–2012–D–1002] • Mail/Hand delivery/Courier (for
(1) If a state’s program change will Questions and Answers Regarding written/paper submissions): Division of
affect the resources or interests of any Food Facility Registration (Seventh Dockets Management (HFA–305), Food
federally-recognized American Indian or Edition); Draft Guidance for Industry; and Drug Administration, 5630 Fishers
Alaska Native tribal government (tribe), Availability Lane, Rm. 1061, Rockville, MD 20852.
NOAA shall contact the affected tribe(s) • For written/paper comments
and determine if Government-to- AGENCY: Food and Drug Administration, submitted to the Division of Dockets
Government consultation is desired HHS. Management, FDA will post your
under Executive Order 13175 (Nov. 6, ACTION: Notification of availability. comment, as well as any attachments,
2000). except for information submitted,
SUMMARY: The Food and Drug marked and identified, as confidential,
(2) If, for the purposes of ESA, NHPA, Administration (FDA or we) is if submitted as detailed in
MSFCMA or MMPA compliance, NOAA announcing the availability of a draft ‘‘Instructions.’’
determines that a state’s program change guidance for industry entitled Instructions: All submissions received
will have effects on listed threatened or ‘‘Questions and Answers Regarding must include the Docket No. FDA–
endangered species, historic properties, Food Facility Registration (Seventh 2012–D–1002 for the draft guidance for
essential fish habitat or marine Edition): Guidance for Industry.’’ This industry entitled ‘‘Questions and
mammals, then NOAA shall determine draft guidance contains 15 sections of a Answers Regarding Food Facility
if consultation is needed with the multisection guidance intended to Registration (Seventh Edition).’’
applicable federal agency under the provide updated information relating to Received comments will be placed in
ESA, NHPA, MSFCMA and MMPA. the food facility registration the docket and, except for those
(3) When NOAA determines whether requirements in the Federal Food, Drug, submitted as ‘‘Confidential
to consult under other federal statutes or and Cosmetic Act (the FD&C Act). Submissions,’’ publicly viewable at
tribal executive orders, NOAA’s ability DATES: Although you can comment on http://www.regulations.gov or at the
to require changes to a state’s proposed any guidance at any time (see 21 CFR Division of Dockets Management
program change are limited by the 10.115(g)(5)), to ensure that we consider between 9 a.m. and 4 p.m., Monday
following: your comment on the draft guidance through Friday.
(i) Once NOAA approves a state’s before we begin work on the final • Confidential Submissions—To
management program, NOAA cannot version of the guidance, submit either submit a comment with confidential
require a state to change its program. electronic or written comments on the information that you do not wish to be
NOAA can, through periodic draft guidance by February 6, 2017. made publicly available, submit your
evaluations of a state’s management ADDRESSES: You may submit comments comments only as a written/paper
program under section 312 of the Act, as follows: submission. You should submit two
establish necessary actions if NOAA copies total. One copy will include the
Electronic Submissions information you claim to be confidential
finds a state is not adhering to its
NOAA-approved program, but NOAA Submit electronic comments in the with a heading or cover note that states
can only recommend that a state change following way: ‘‘THIS DOCUMENT CONTAINS
its program to create a different state • Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION.’’ The
standard or to address emerging issues; www.regulations.gov. Follow the Agency will review this copy, including
and instructions for submitting comments. the claimed confidential information, in
Comments submitted electronically, its consideration of comments. The
(ii) NOAA can approve or disapprove including attachments, to http:// second copy, which will have the
a program change request. When NOAA www.regulations.gov will be posted to claimed confidential information
reviews a program change, NOAA has a the docket unchanged. Because your redacted/blacked out, will be available
limited ability to require a state to make comment will be made public, you are for public viewing and posted on http://
changes to state policies. If NOAA solely responsible for ensuring that your www.regulations.gov. Submit both
disapproves a program change request, comment does not include any copies to the Division of Dockets
this does not require a state to change confidential information that you or a Management. If you do not wish your
state law. Therefore, there is no effect third party may not wish to be posted, name and contact information to be
from NOAA’s denial on the such as medical information, your or made publicly available, you can
implementation of state law at the state anyone else’s Social Security number, or provide this information on the cover
(or local government) level. NOAA’s confidential business information, such sheet and not in the body of your
denial means the disapproved state as a manufacturing process. Please note comments and you must identify this
policy is not part of the state’s NOAA- that if you include your name, contact information as ‘‘confidential.’’ Any
approved management program and information, or other information that information marked as ‘‘confidential’’
Lhorne on DSK30JT082PROD with PROPOSALS
cannot be used for CZMA federal identifies you in the body of your will not be disclosed except in
consistency purposes. NOAA cannot comments, that information will be accordance with 21 CFR 10.20 and other
use a program change to require changes posted on http://www.regulations.gov. applicable disclosure law. For more
to other parts of a state’s management • If you want to submit a comment information about FDA’s posting of
program. with confidential information that you comments to public dockets, see 80 FR
[FR Doc. 2016–26680 Filed 11–7–16; 8:45 am] do not wish to be made available to the 56469, September 18, 2015, or access
BILLING CODE 3510–08–P public, submit the comment as a the information at: http://www.fda.gov/
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![78528 Federal Register / Vol. 81, No. 216 / Tuesday, November 8, 2016 / Proposed Rules
Management and Budget (OMB) under anyone else’s Social Security number, or sheet and not in the body of your
the Paperwork Reduction Act of 1995 confidential business information, such comments and you must identify this
(44 U.S.C. 3501–3520). The collections as a manufacturing process. Please note information as ‘‘confidential.’’ Any
of information in 21 CFR 1.230 through that if you include your name, contact information marked as ‘‘confidential’’
1.235 and 21 CFR 1.245 have been information, or other information that will not be disclosed except in
approved under OMB control number identifies you in the body of your accordance with 21 CFR 10.20 and other
0910–0502. comment, that information will be applicable disclosure law. For more
Dated: November 3, 2016. posted on http://www.regulations.gov. information about FDA’s posting of
• If you want to submit a comment comments to public dockets, see 80 FR
Leslie Kux,
with confidential information that you 56469, September 18, 2015, or access
Associate Commissioner for Policy. do not wish to be made available to the the information at: http://www.fda.gov/
[FR Doc. 2016–26930 Filed 11–7–16; 8:45 am] public, submit the comment as a regulatoryinformation/dockets/
BILLING CODE 4164–01–P written/paper submission and in the default.htm.
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Submissions’’ and ‘‘Instructions’’). read background documents or the
DEPARTMENT OF HEALTH AND electronic and written/paper comments
HUMAN SERVICES Written/Paper Submissions
received, go to http://
Submit written/paper submissions as www.regulations.gov and insert the
Food and Drug Administration follows: docket number, found in brackets in the
• Mail/Hand delivery/Courier (for heading of this document, into the
21 CFR Part 573 written/paper submissions): Division of
‘‘Search’’ box and follow the prompts
[Docket No. FDA–2014–F–0452] Dockets Management (HFA–305), Food
and/or go to the Division of Dockets
and Drug Administration, 5630 Fishers
Management, 5630 Fishers Lane, Rm.
Novus International, Inc.; Filing of Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments 1061, Rockville, MD 20852.
Food Additive Petition (Animal Use)
submitted to the Division of Dockets FOR FURTHER INFORMATION CONTACT:
AGENCY: Food and Drug Administration, Management, FDA will post your Carissa Doody, Center for Veterinary
HHS. comment, as well as any attachments, Medicine (HFV–228), Food and Drug
ACTION: Notice of petition. except for information submitted, Administration, 7519 Standish Pl.,
marked and identified, as confidential, Rockville, MD 20855, 240–402–6283,
SUMMARY: The Food and Drug if submitted as detailed in carissa.doody@fda.hhs.gov.
Administration (FDA) is announcing ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION: Under the
that Novus International, Inc., has filed Instructions: All submissions received Federal Food, Drug, and Cosmetic Act
a petition proposing that the food must include the Docket No. FDA– (section 409(b)(5) (21 U.S.C. 348(b)(5)),
additive regulations be amended to 2014–F–0452 for ‘‘Food Additives notice is given that a food additive
provide for the safe use of poly (2- Permitted in Feed and Drinking Water petition (FAP 2295) has been filed by
vinylpyridine-co-styrene) as a nutrient of Animals; 2-Vinylpyridine-Co- Novus International, Inc., 20 Research
protectant for methionine hydroxy Styrene.’’ Received comments will be Park Dr., Saint Charles, MO 63304. The
analog in animal food for beef cattle, placed in the docket and, except for petition proposes to amend part 573 (21
dairy cattle, and replacement dairy those submitted as ‘‘Confidential CFR part 573) Food Additives Permitted
heifers. Additionally, the petition Submissions,’’ publicly viewable at in Feed and Drinking Water of Animals
proposes that the food additive http://www.regulations.gov or at the to provide for the safe use of poly (2-
regulations be amended to provide for Division of Dockets Management vinylpyridine-co-styrene) as a nutrient
the safe use of ethyl cellulose as a between 9 a.m. and 4 p.m., Monday protectant for methionine hydroxy
binder for methionine hydroxy analog to through Friday. analog in animal food for beef cattle,
be incorporated into animal food. • Confidential Submissions—To dairy cattle, and replacement dairy
DATES: Submit either electronic or submit a comment with confidential heifers, and to provide for the safe use
written comments on the petitioner’s information that you do not wish to be of ethyl cellulose as a binder for
environmental assessment by December made publicly available, submit your methionine hydroxy analog to be
8, 2016. comment only as a written/paper incorporated into animal food.
ADDRESSES: You may submit comments submission. You should submit two The potential environmental impact
as follows: copies total. One copy will include the of this action is being reviewed. To
information you claim to be confidential encourage public participation
Electronic Submissions with a heading or cover note that states consistent with regulations issued under
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS the National Environmental Policy Act
following way: CONFIDENTIAL INFORMATION.’’ The (40 CFR 1501.4(b)), the Agency is
• Federal eRulemaking Portal: http:// Agency will review this copy, including placing the environmental assessment
www.regulations.gov. Follow the the claimed confidential information, in submitted with the petition that is the
instructions for submitting comments. its consideration of comments. The subject of this notice on public display
Comments submitted electronically, second copy, which will have the at the Division of Dockets Management
including attachments, to http:// claimed confidential information (see ADDRESSES) for public review and
www.regulations.gov will be posted to redacted/blacked out, will be available comment. Interested persons may
Lhorne on DSK30JT082PROD with PROPOSALS
the docket unchanged. Because your for public viewing and posted on http:// submit to the Division of Dockets
comment will be made public, you are www.regulations.gov. Submit both Management (see DATES and ADDRESSES)
solely responsible for ensuring that your copies to the Division of Dockets either electronic or written comments
comment does not include any Management. If you do not wish your regarding this document. It is only
confidential information that you or a name and contact information to be necessary to send one set of comments.
third party may not wish to be posted, made publicly available, you can Identify comments with the docket
such as medical information, your or provide this information on the cover number found in brackets in the
VerDate Sep<11>2014 14:20 Nov 07, 2016 Jkt 241001 PO 00000 Frm 00015 Fmt 4702 Sfmt 4702 E:\FR\FM\08NOP1.SGM 08NOP1](https://thefederalregister.org/doc/81_FR_78742/page/3.svg)
Document Created: 2018-02-14 08:23:41
Document Modified: 2018-02-14 08:23:41
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Notification of availability. | |
| Dates | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 6, 2017. | |
| Contact | Courtney Buchanan, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2487. | |
| FR Citation | 81 FR 78526 |
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