81 FR 75349 - Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety Modernization Act: Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 210 (October 31, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 210 (October 31, 2016)
| Page Range | 75349-75351 | |
| FR Document | 2016-26245 |
[Federal Register Volume 81, Number 210 (Monday, October 31, 2016)] [Proposed Rules] [Pages 75349-75351] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26245] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 112, 117, and 507 [Docket No. FDA-2016-D-2841] Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety Modernization Act: Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled ``Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety Modernization Act: Guidance for Industry.'' This draft guidance explains our current thinking on disclosure statements made by an entity, in documents accompanying food, that certain hazards have not been controlled by that entity as required by certain provisions in four final rules. This document describes our current thinking on how to describe the hazard under each of the four rules and which documents we consider to be ``documents of the trade'' for the purpose of disclosure statements. 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you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on this draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 1, 2017. Submit either electronic or written comments on the proposed collection of information by May 1, 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 [[Page 75350]] 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-2016-D-2841 for ``Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety Modernization Act: Guidance for Industry.'' 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/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 Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration (HFS-300), 5001 Campus Drive, 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: With regard to this draft guidance: For questions regarding this draft guidance as it relates to our regulation entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food,'' contact Jenny Scott, Center for Food Safety and Applied Nutrition, (HFS-300), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2166. For questions regarding this draft guidance as it relates to our regulation entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals,'' contact Jeanette Murphy, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240- 402-6246. For questions regarding this draft guidance as it relates to our regulation entitled ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,'' contact Samir Assar, Center for Food Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-401-1636. For questions regarding this draft guidance as it relates to our regulation entitled ``Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals,'' contact Rebecca Buckner, Office of Food and Veterinary Medicine, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4576. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a draft guidance for industry entitled ``Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety Modernization Act: Guidance for Industry.'' We are issuing the draft guidance consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA 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. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations. The draft guidance relates to four of the seven foundational rules that we have established in Title 21 of the Code of Federal Regulations (21 CFR) as part of our implementation of the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353). Table 1 lists these four rules. Each of these rules includes ``customer provisions'' as specified in table 1. Table 1--The Four Foundational FSMA Rules Relevant to the Draft Guidance ---------------------------------------------------------------------------------------------------------------- Title and abbreviations for the purpose of this document Regulatory codification ``Customer provisions'' Publication ---------------------------------------------------------------------------------------------------------------- Current Good Manufacturing Practice, 21 CFR part 117........ 21 CFR 117.136(a)(2), 80 FR 55908, September Hazard Analysis, and Risk-Based (3), and (4). 17, 2015. Preventive Controls for Human Food (part 117). [[Page 75351]] Current Good Manufacturing Practice, 21 CFR part 507........ 21 CFR 507.36(a)(2), 80 FR 56170, September Hazard Analysis, and Risk-Based (3), and (4). 17, 2015. Preventive Controls for Food for Animals (part 507). Standards for the Growing, 21 CFR part 112........ 21 CFR 112.2(b)........ 80 FR 74354, November Harvesting, Packing, and Holding of 27, 2015. Produce for Human Consumption (produce safety regulation). Foreign Supplier Verification 21 CFR part 1, subpart 21 CFR 1.507(a)(2)(i), 80 FR 74226, November Programs (FSVP) for Importers of L. (a)(3)(i), and 27, 2015. Food for Humans and Animals (FSVP (a)(4)(i). regulation). ---------------------------------------------------------------------------------------------------------------- The ``customer provisions'' of part 117 and part 507 each include a requirement for a ``disclosure statement'' in which a manufacturer/ processor must disclose, in documents accompanying the food, in accordance with the practice of the trade, that the food is ``not processed to control [identified hazard]'' in certain circumstances. Likewise, the ``customer provisions'' of the FSVP regulation include a requirement for a ``disclosure statement'' in which an importer must disclose, in documents accompanying the food, in accordance with the practice of the trade, that the food is ``not processed to control [identified hazard]'' in certain circumstances. The ``customer provisions'' of the produce safety regulation relate to an exemption from that regulation that includes a requirement for a ``disclosure statement'' in which a farm must disclose, in documents accompanying the food, in accordance with the practice of the trade, that the food is ``not processed to adequately reduce the presence of microorganisms of public health significance.'' The draft guidance responds to industry questions regarding these requirements for a disclosure statement. On March 23, 2016, FDA met with a food trade association at their request to listen to concerns regarding the customer provisions of part 117 (Ref. 1), including concerns regarding the disclosure statement in part 117. At the meeting, the trade association expressed concern about providing a disclosure statement when multiple hazards may be present, including chemical hazards (such as mycotoxins) and physical hazards (such as stones in raw agricultural commodities), as well as for multiple biological hazards (such as microbial pathogens). The trade association also asked us to allow a variety of types of documents that accompany the food to have the disclosure statement (e.g., contractual agreements, Web sites referenced on labels and in contracts, labels, letters of guarantee, shipment-specific certificates of analysis, shipping documents, specifications, and terms and conditions). The trade association focused its discussion on the requirements of part 117, but noted that it had parallel concerns for the analogous provisions of part 507 and the FSVP regulation (Ref. 1). Although the trade association did not express concern with the disclosure statement in the produce safety regulation, we believe it will be helpful to businesses subject to the produce safety regulation, to include our current thinking on the disclosure statement in all four rules that have requirements for a disclosure statement, not just the three rules mentioned by the trade association. II. 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 Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 117 have been approved under OMB control number 0910-0751. The collections of information in 21 CFR part 507 have been approved under OMB control number 0910-0789. The collections of information in 21 CFR part 112 have been approved under OMB control number 0910-0816. The collections of information in 21 CFR part 1, subpart L have been approved under OMB control number 0910- 0752. III. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance. IV. References The following references are on display in the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http://www.regulations.gov. 1. Grocery Manufacturers Association, ``21 CFR 117.136. Industry Impacts from Disclosure and Written Assurance Requirements,'' 2016. Dated: October 26, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-26245 Filed 10-28-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 210 / Monday, October 31, 2016 / Proposed Rules 75349
some cases, the passengers may choose view the delayed baggage fee refund DEPARTMENT OF HEALTH AND
to receive notice when their bags arrive provision in the FAA Extension Act HUMAN SERVICES
and pick up the bags at the carrier’s differently from Regulation Z in that the
baggage office at the destination airport. Act only requires a passenger to notify Food and Drug Administration
How should we determine that the bags the carrier that a bag is delayed or lost,
have been ‘‘delivered’’ to the passenger and there is not a requirement for the 21 CFR Parts 1, 112, 117, and 507
and therefore stop the clock from passenger to request a refund for the [Docket No. FDA–2016–D–2841]
running in each of these situations? baggage fee. We emphasize that since
DOT seeks comment on the number of Describing a Hazard That Needs
the Act’s automated refund requirement
bags that are delayed annually based on Control in Documents Accompanying
covers all bags that are delayed for more
the 12 and 18 hour and 15 and 30 hour the Food, as Required by Four Rules
statutory timeframes, and lost bags. The than a set number of hours, it will also
cover ‘‘lost bags,’’ refunding fees Implementing the FDA Food Safety
Department receives information on the Modernization Act: Guidance for
number of mishandled-baggage reports charged for which is already required by
Industry; Availability
filed by passengers, but we do not have 14 CFR 259.5(b)(3).6 As such, both bags
data on how many of these are delayed delayed for more than the set number of AGENCY: Food and Drug Administration,
bags, and how many are lost. hours and bags that are considered HHS.
Information on the number of delayed ‘‘lost’’ would be eligible for an ACTION: Notification of availability.
and lost bags that would be affected by automated refund.
SUMMARY: The Food and Drug
this rulemaking would help the The Department seeks comment on Administration (FDA, we, or Agency) is
Department to better estimate the whether prescribing a specific announcing the availability of a draft
impact this rule would have on mechanism for the carriers to use to guidance for industry entitled
consumers and airlines. provide the statutorily required ‘‘Describing a Hazard That Needs
Method for Refunding Delayed Baggage automated refund would negatively or Control in Documents Accompanying
The Department is also seeking positively impact carriers and the Food, as Required by Four Rules
comment on the appropriate method for consumers. What procedures would be Implementing the FDA Food Safety
providing a refund for delayed baggage. necessary on interline itineraries, for Modernization Act: Guidance for
The Department’s credit card refund which the carrier to whom the Industry.’’ This draft guidance explains
regulation, 14 CFR part 374, implements passenger reports the delayed bag at his our current thinking on disclosure
the Consumer Credit Protection Act and or her destination or stopover is not the statements made by an entity, in
Regulation Z of the Board of Governors carrier to whom the passenger had paid documents accompanying food, that
of the Federal Reserve System, 15 U.S.C. the baggage fee? In addition to soliciting certain hazards have not been controlled
1601–1693r and 12 CFR part 226 comment on all of the issues and by that entity as required by certain
(Regulation Z) with respect to air concerns identified above, we also provisions in four final rules. This
carriers and foreign air carriers. It states welcome and any other information document describes our current
that when refunds are due on purchases relevant to this issue. This specifically thinking on how to describe the hazard
with a credit card, a carrier must under each of the four rules and which
includes comments and data on the cost
transmit a credit statement to the credit documents we consider to be
impact on new-entrant carriers (many of
card issuer within seven business days ‘‘documents of the trade’’ for the
whom do not have interline agreements)
of receipt of full documentation for the purpose of disclosure statements.
of the time standard developed in this
refund requested. In addition, the DATES: Although you can comment on
proceeding, and the cost impact on
Department requires that, with respect any guidance at any time (see 21 CFR
to purchases with forms of payment regional airlines.
10.115(g)(5)), to ensure that we consider
other than credit cards, an airline must Issued this 18th day of October, 2016, in your comment on this draft guidance
provide a refund within 20 days of Washington, DC. before we begin work on the final
receipt of full documentation of such a Anthony R. Foxx, version of the guidance, submit either
request. See 14 CFR 259.5(b)(5). The Secretary of Transportation. electronic or written comments on the
Department applies these refund [FR Doc. 2016–26199 Filed 10–28–16; 8:45 am] draft guidance by May 1, 2017. Submit
standards to all refunds that are due to either electronic or written comments
BILLING CODE 4910–9X–P
consumers, including airfare refunds on the proposed collection of
and ancillary fee refunds. In order to information by May 1, 2017.
receive a refund under Regulation Z, a ADDRESSES: You may submit comments
consumer must request the refund from as follows:
the carrier and provide all necessary
supporting documents. In contrast, the 6 We have not defined ‘‘lost’’ for purposes of 14 Electronic Submissions
Act states that carriers should CFR 259.5(b)(3) mandating a refund of the baggage
Submit electronic comments in the
fee for lost bags. Instead, in a Frequently Asked
‘‘promptly provide an automated Questions document issued by the Department’s
following way:
refund’’ to an eligible passenger when Office of Aviation Enforcement and Proceedings, • Federal eRulemaking Portal: http://
the carriers fail to meet the applicable that office states that if a carrier unreasonably www.regulations.gov. Follow the
time limit in delivering the checked bag, refuses to consider a bag to be lost after it has been instructions for submitting comments.
and the passenger has notified the missing for a considerable period of time, it could Comments submitted electronically,
Lhorne on DSK30JT082PROD with PROPOSALS
carrier of the lost or delayed checked be subject to enforcement action for violating the including attachments, to http://
baggage. Under the Act, an ‘‘automated statutory prohibition against unfair and deceptive www.regulations.gov will be posted to
practices. See, Answers to Frequently Asked
refund’’ should be issued to passengers the docket unchanged. Because your
Questions Concerning the Enforcement of the
as long as the delay has met the Second Final Rule on Enhancing Airline Passenger
comment will be made public, you are
threshold timeframe and the passenger Protections (EAPP #2), last updated May 8, 2015, solely responsible for ensuring that your
has notified the carrier about the https://www.transportation.gov/sites/dot.gov/files/ comment does not include any
delayed or lost bag. In that regard, we docs/EAPP_2_FAQ_2_0.pdf. confidential information that you or a
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![Federal Register / Vol. 81, No. 210 / Monday, October 31, 2016 / Proposed Rules 75351
TABLE 1—THE FOUR FOUNDATIONAL FSMA RULES RELEVANT TO THE DRAFT GUIDANCE—Continued
Title and abbreviations for the purpose of this document Regulatory codification ‘‘Customer provisions’’ Publication
Current Good Manufacturing Practice, Hazard Analysis, 21 CFR part 507 ............... 21 CFR 507.36(a)(2), (3), 80 FR 56170, September
and Risk-Based Preventive Controls for Food for Ani- and (4). 17, 2015.
mals (part 507).
Standards for the Growing, Harvesting, Packing, and 21 CFR part 112 ............... 21 CFR 112.2(b) ............... 80 FR 74354, November
Holding of Produce for Human Consumption (produce 27, 2015.
safety regulation).
Foreign Supplier Verification Programs (FSVP) for Im- 21 CFR part 1, subpart L .. 21 CFR 1.507(a)(2)(i), 80 FR 74226, November
porters of Food for Humans and Animals (FSVP reg- (a)(3)(i), and (a)(4)(i). 27, 2015.
ulation).
The ‘‘customer provisions’’ of part of analysis, shipping documents, 1061, Rockville, MD 20852, and are
117 and part 507 each include a specifications, and terms and available for viewing by interested
requirement for a ‘‘disclosure conditions). persons between 9 a.m. and 4 p.m.,
statement’’ in which a manufacturer/ The trade association focused its Monday through Friday; they are also
processor must disclose, in documents discussion on the requirements of part available electronically at http://
accompanying the food, in accordance 117, but noted that it had parallel www.regulations.gov.
with the practice of the trade, that the concerns for the analogous provisions of 1. Grocery Manufacturers Association, ‘‘21
food is ‘‘not processed to control part 507 and the FSVP regulation (Ref. CFR 117.136. Industry Impacts from
[identified hazard]’’ in certain 1). Although the trade association did Disclosure and Written Assurance
circumstances. Likewise, the ‘‘customer not express concern with the disclosure Requirements,’’ 2016.
provisions’’ of the FSVP regulation statement in the produce safety
Dated: October 26, 2016.
include a requirement for a ‘‘disclosure regulation, we believe it will be helpful
Leslie Kux,
statement’’ in which an importer must to businesses subject to the produce
safety regulation, to include our current Associate Commissioner for Policy.
disclose, in documents accompanying
thinking on the disclosure statement in [FR Doc. 2016–26245 Filed 10–28–16; 8:45 am]
the food, in accordance with the
practice of the trade, that the food is all four rules that have requirements for BILLING CODE 4164–01–P
‘‘not processed to control [identified a disclosure statement, not just the three
hazard]’’ in certain circumstances. The rules mentioned by the trade
association. DEPARTMENT OF HEALTH AND
‘‘customer provisions’’ of the produce
HUMAN SERVICES
safety regulation relate to an exemption II. Paperwork Reduction Act of 1995
from that regulation that includes a Food and Drug Administration
This draft guidance refers to
requirement for a ‘‘disclosure
previously approved collections of
statement’’ in which a farm must 21 CFR Parts 16 and 58
information found in FDA regulations.
disclose, in documents accompanying
These collections of information are
the food, in accordance with the [Docket No. FDA–2010–N–0548]
subject to review by the Office of
practice of the trade, that the food is
Management and Budget (OMB) under
‘‘not processed to adequately reduce the Good Laboratory Practice for
the Paperwork Reduction Act of 1995
presence of microorganisms of public Nonclinical Laboratory Studies;
(44 U.S.C. 3501–3520). The collections
health significance.’’ Extension of Comment Period
of information in 21 CFR part 117 have
The draft guidance responds to
been approved under OMB control AGENCY: Food and Drug Administration,
industry questions regarding these
number 0910–0751. The collections of HHS.
requirements for a disclosure statement.
information in 21 CFR part 507 have Proposed rule; extension of
ACTION:
On March 23, 2016, FDA met with a been approved under OMB control
food trade association at their request to comment period.
number 0910–0789. The collections of
listen to concerns regarding the information in 21 CFR part 112 have
customer provisions of part 117 (Ref. 1), SUMMARY: The Food and Drug
been approved under OMB control Administration (FDA) is extending the
including concerns regarding the number 0910–0816. The collections of
disclosure statement in part 117. At the comment period for the proposed rule
information in 21 CFR part 1, subpart L that appeared in the Federal Register of
meeting, the trade association expressed have been approved under OMB control
concern about providing a disclosure August 24, 2016. In the proposed rule,
number 0910–0752. FDA requested comments on its
statement when multiple hazards may
be present, including chemical hazards III. Electronic Access proposal to amend the regulations for
(such as mycotoxins) and physical good laboratory practice for nonclinical
Persons with access to the Internet studies. The Agency is taking this action
hazards (such as stones in raw may obtain the draft guidance at either
agricultural commodities), as well as for in response to requests for an extension
http://www.fda.gov/FoodGuidances or to allow interested persons additional
multiple biological hazards (such as http://www.regulations.gov. Use the
microbial pathogens). The trade time to submit comments.
Lhorne on DSK30JT082PROD with PROPOSALS
FDA Web site listed in the previous
association also asked us to allow a DATES: FDA is extending the comment
sentence to find the most current
variety of types of documents that version of the guidance. period on the proposed rule published
accompany the food to have the August 24, 2016 (81 FR 58342). Submit
disclosure statement (e.g., contractual IV. References either electronic or written comments
agreements, Web sites referenced on The following references are on by January 21, 2017.
labels and in contracts, labels, letters of display in the Division of Dockets ADDRESSES: You may submit comments
guarantee, shipment-specific certificates Management, 5630 Fishers Lane, Rm. as follows:
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Document Created: 2018-02-02 12:13:32
Document Modified: 2018-02-02 12:13:32
| 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 this draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 1, 2017. Submit either electronic or written comments on the proposed collection of information by May 1, 2017. | |
| Contact | With regard to this draft guidance: For questions regarding this draft guidance as it relates to our regulation entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food,'' contact Jenny Scott, Center for Food Safety and Applied Nutrition, (HFS-300), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2166. | |
| FR Citation | 81 FR 75349 | |
| CFR Citation | 21
CFR
1 21 CFR 112 21 CFR 117 21 CFR 507 |
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