81 FR 57816 - Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 164 (August 24, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 164 (August 24, 2016)
| Page Range | 57816-57818 | |
| FR Document | 2016-20177 |
[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)] [Proposed Rules] [Pages 57816-57818] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-20177] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 117 [Docket No. FDA-2016-D-2343] Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled ``Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry.'' This draft guidance document includes several chapters of a multi-chapter guidance intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under our rule entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.'' 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you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on this draft guidance before we issue the final version of the guidance, submit either electronic or written comments on the draft guidance by February 21, 2017. ADDRESSES: You may submit comments as follows: [[Page 57817]] 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-2016-D-2343 for ``Hazard Analysis and Risk-Based Preventive Controls for Human Food: 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 Office of Food Safety, Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS-300), 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: 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. SUPPLEMENTARY INFORMATION: I. Background The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables FDA to better protect public health by helping to ensure the safety and security of the food supply. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. FSMA recognizes the important role industry plays in ensuring the safety of the food supply, including the adoption of modern systems of preventive controls in food production. Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act), in section 418 of the FD&C Act (21 U.S.C. 350g), by adding requirements for hazard analysis and risk-based preventive controls for establishments that are required to register as food facilities under our regulations, in 21 CFR part 1, subpart H, in accordance with section 415 of the FD&C Act (21 U.S.C. 350d). We have established regulations to implement these requirements within part 117 (21 CFR part 117). We are announcing the availability of several chapters of a multi- chapter draft guidance for industry entitled ``Hazard Analysis and Risk-Based Preventive Controls for Human Food.'' 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 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. The multi-chapter draft guidance for industry is intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under part 117, principally in subparts C and G. The chapters that we are announcing in this document are as follows: Introduction Chapter One--The Food Safety Plan Chapter Two--Conducting a Hazard Analysis Chapter Three--Potential Hazards Associated with the Manufacturing, Processing, Packing, and Holding of Human Food Chapter Four--Preventive Controls Chapter Five--Application of Preventive Controls and Preventive Control Management Components We intend to announce the availability for public comment of additional chapters of the draft guidance as we complete them. 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 [[Page 57818]] the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 117 have been approved under OMB control number 0910-0751. 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. Dated: August 18, 2016. Jeremy Sharp, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2016-20177 Filed 8-23-16; 8:45 am] BILLING CODE 4164-01-P
![57816 Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Proposed Rules
IX. Paperwork Reduction Act including dietary supplements, that bear investigator has presented adequate
FDA tentatively concludes that this a nutrient content claim or a health assurances that the investigator will
proposed rule contains no collection of claim, infant formulas, food and color employ all test articles, and will
information. Therefore, clearance by additives, and tobacco products; and conduct any clinical investigation that
OMB under the Paperwork Reduction (ii) Any nonclinical laboratory study supports an application for a research or
Act of 1995 is not required. intended to support an application for a marketing permit for products regulated
research or marketing permit for a new by FDA and any nonclinical laboratory
X. Federalism animal drug. study intended to support an
We have analyzed this proposed rule * * * * * application for a research or marketing
in accordance with the principles set permit for a new animal drug, solely in
forth in Executive Order 13132. We PART 511—NEW ANIMAL DRUGS FOR compliance with the applicable
have determined that the proposed rule, INVESTIGATIONAL USE provisions of this chapter.
if finalized, would not contain policies ■ 3. The authority citation for part 511 * * * * *
that would have substantial direct continues to read as follows: Dated: August 16, 2016.
effects on the States, on the relationship Peter Lurie,
Authority: 21 U.S.C. 321, 351, 352, 353,
between the National Government and
360b, 371. Associate Commissioner for Public Health
the States, or on the distribution of Strategy and Analysis.
power and responsibilities among the ■ 4. In § 511.1, revise the section
heading, the last sentences in [FR Doc. 2016–19876 Filed 8–23–16; 8:45 am]
various levels of government.
Accordingly, the Agency tentatively paragraphs (c)(1) and (2), and revise BILLING CODE 4164–01–P
concludes that the proposed rule does paragraph (c)(6) to read as follows:
not contain policies that have § 511.1 New animal drugs for DEPARTMENT OF HEALTH AND
federalism implications as defined in investigational use exempt from section HUMAN SERVICES
the Executive order and, consequently, 512(a) of the Federal Food, Drug, and
a federalism summary impact statement Cosmetic Act. Food and Drug Administration
is not required. * * * * *
List of Subjects (c) * * * 21 CFR Part 117
(1) * * * If an explanation is offered
21 CFR Part 16 but not accepted by the Center for [Docket No. FDA–2016–D–2343]
Administrative practice and Veterinary Medicine, the investigator
procedure. will be given an opportunity for a Hazard Analysis and Risk-Based
regulatory hearing under part 16 of this Preventive Controls for Human Food;
21 CFR Part 511 chapter on the question of whether the Draft Guidance for Industry;
Animal drugs, Medical research, investigator is eligible to receive test Availability
Reporting and recordkeeping articles under this part and eligible to
requirements. conduct: AGENCY: Food and Drug Administration,
Therefore, under the Federal Food, (i) Any clinical investigation that HHS.
Drug, and Cosmetic Act and under supports an application for a research or
marketing permit for products regulated ACTION: Notification of availability.
authority delegated to the Commissioner
of Food and Drugs, it is proposed that by FDA; and
(ii) Any nonclinical laboratory study SUMMARY: The Food and Drug
parts 16 and 511 be amended as follows: Administration (FDA, we, or Agency) is
intended to support an application for a
PART 16—REGULATORY HEARING research or marketing permit for a new announcing the availability of a draft
BEFORE THE FOOD AND DRUG animal drug. guidance for industry entitled ‘‘Hazard
ADMINISTRATION (2) * * * The notification also will Analysis and Risk-Based Preventive
explain that an investigator determined Controls for Human Food: Guidance for
■ 1. The authority citation for part 16 to be ineligible to receive a test article Industry.’’ This draft guidance
continues to read as follows: under this part will be ineligible to document includes several chapters of a
conduct multi-chapter guidance intended to
Authority: 15 U.S.C. 1451–1461; 21 U.S.C.
141–149, 321–394, 467f, 679, 821, 1034; 28 (i) Any clinical investigation that explain our current thinking on how to
U.S.C. 2112; 42 U.S.C. 201–262, 263b, 364. supports an application for a research or comply with the requirements for
marketing permit for products regulated hazard analysis and risk-based
■ 2. In § 16.1, in paragraph (b)(2), revise preventive controls under our rule
by FDA, including drugs, biologics,
the numerically sequenced entry for entitled ‘‘Current Good Manufacturing
devices, new animal drugs, foods,
§ 511.1(c)(1) to read as follows: Practice, Hazard Analysis, and Risk-
including dietary supplements, that bear
§ 16.1 Scope. a nutrient content claim or a health Based Preventive Controls for Human
* * * * * claim, infant formulas, food and color Food.’’
(b) * * * additives, and tobacco products, and
(ii) Any nonclinical laboratory study DATES: Although you can comment on
(2) * * * any guidance at any time (see 21 CFR
§ 511.1(c)(1), relating to whether an intended to support an application for a
mstockstill on DSK3G9T082PROD with PROPOSALS
research or marketing permit for a new 10.115(g)(5)), to ensure that we consider
investigator is eligible to receive test your comment on this draft guidance
articles under part 511 and eligible to animal drug.
before we issue the final version of the
conduct: * * * * * guidance, submit either electronic or
(i) Any clinical investigation that (6) An investigator who has been
written comments on the draft guidance
supports an application for a research or determined to be ineligible under
by February 21, 2017.
marketing permit for products regulated paragraph (c)(2) of this section may be
by FDA including drugs, biologics, reinstated as eligible when the ADDRESSES: You may submit comments
devices, new animal drugs, foods, Commissioner determines that the as follows:
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![57818 Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Proposed Rules
the Paperwork Reduction Act of 1995 comment does not include any made publicly available, you can
(44 U.S.C. 3501–3520). The collections confidential information that you or a provide this information on the cover
of information in part 117 have been third party may not wish to be posted, sheet and not in the body of your
approved under OMB control number such as medical information, your or comments and you must identify this
0910–0751. anyone else’s Social Security number, or information as ‘‘confidential.’’ Any
confidential business information, such information marked as ‘‘confidential’’
III. Electronic Access as a manufacturing process. Please note will not be disclosed except in
Persons with access to the Internet that if you include your name, contact accordance with 21 CFR 10.20 and other
may obtain the draft guidance at either information, or other information that applicable disclosure law. For more
http://www.fda.gov/FoodGuidances or identifies you in the body of your information about FDA’s posting of
http://www.regulations.gov. Use the comments, that information will be comments to public dockets, see 80 FR
FDA Web site listed in the previous posted on http://www.regulations.gov. 56469, September 18, 2015, or access
sentence to find the most current • If you want to submit a comment the information at: http://www.fda.gov/
version of the guidance. with confidential information that you regulatoryinformation/dockets/
Dated: August 18, 2016.
do not wish to be made available to the default.htm.
public, submit the comment as a Docket: For access to the docket to
Jeremy Sharp,
written/paper submission and in the read background documents or the
Deputy Commissioner for Policy, Planning, manner detailed (see ‘‘Written/Paper
Legislation, and Analysis. electronic and written/paper comments
Submissions’’ and ‘‘Instructions’’). received, go to http://
[FR Doc. 2016–20177 Filed 8–23–16; 8:45 am]
Written/Paper Submissions www.regulations.gov and insert the
BILLING CODE 4164–01–P
docket number, found in brackets in the
Submit written/paper submissions as heading of this document, into the
follows:
‘‘Search’’ box and follow the prompts
DEPARTMENT OF HEALTH AND • Mail/Hand delivery/Courier (for
HUMAN SERVICES and/or go to the Division of Dockets
written/paper submissions): Division of
Dockets Management (HFA–305), Food Management, 5630 Fishers Lane, rm.
Food and Drug Administration and Drug Administration, 5630 Fishers 1061, Rockville, MD 20852.
Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT:
21 CFR Part 558 • For written/paper comments David Edwards, Center for Veterinary
[Docket No. FDA–2016–N–1896] submitted to the Division of Dockets Medicine (HFV–220), Food and Drug
Management, FDA will post your Administration, 7519 Standish Pl.,
New Animal Drugs for Use in Animal comment, as well as any attachments, Rockville, MD 20855, 240–402–6205,
Feed; Category Definitions except for information submitted, email: david.edwards@fda.hhs.gov.
marked and identified, as confidential, SUPPLEMENTARY INFORMATION:
AGENCY: Food and Drug Administration, if submitted as detailed in
HHS. Table of Contents
‘‘Instructions.’’
ACTION: Proposed rule. Instructions: All submissions received I. Executive Summary
must include the Docket No. FDA– A. Purpose of the Proposed Rule
SUMMARY: The Food and Drug 2016–N–1896 for ‘‘Category Definitions B. Summary of the Major Provisions of the
Administration (FDA, the Agency, we) for Minor Species.’’ Received comments Proposed Rule
proposes to amend the animal drug will be placed in the docket and, except C. Legal Authority
regulations by revising the definitions of D. Costs and Benefits
for those submitted as ‘‘Confidential II. Background
the two categories of new animal drugs Submissions,’’ publicly viewable at
used in medicated feeds to base category III. Proposed Regulation
http://www.regulations.gov or at the IV. Companion Document to Direct Final
assignment only on approved uses in Division of Dockets Management Rulemaking
major animal species. The proposed between 9 a.m. and 4 p.m., Monday V. Legal Authority
revision will preserve the availability of through Friday. VI. Economic Analysis of Impacts
medicated feeds intended for • Confidential Submissions—To VII. Analysis of Environmental Impact
therapeutic use in minor animal species submit a comment with confidential VIII. Paperwork Reduction Act of 1995
and prevent a significant disincentive information that you do not wish to be IX. Federalism
for future development of additional made publicly available, submit your X. References
minor species therapies. comments only as a written/paper I. Executive Summary
DATES: Submit either electronic or submission. You should submit two
written comments by November 7, 2016. copies total. One copy will include the A. Purpose of the Proposed Rule
ADDRESSES: You may submit comments information you claim to be confidential FDA proposes to revise the definitions
as follows: with a heading or cover note that states of the two categories of new animal
‘‘THIS DOCUMENT CONTAINS drugs used in medicated feeds to base
Electronic Submissions CONFIDENTIAL INFORMATION.’’ The category assignment only on approved
Submit electronic comments in the Agency will review this copy, including uses in major animal species. This
following way: the claimed confidential information, in revision is being proposed to address a
• Federal eRulemaking Portal: http:// its consideration of comments. The potential consequence of animal drug
mstockstill on DSK3G9T082PROD with PROPOSALS
www.regulations.gov. Follow the second copy, which will have the sponsor cooperation in implementing a
instructions for submitting comments. claimed confidential information strategy initiated by the FDA Center for
Comments submitted electronically, redacted/blacked out, will be available Veterinary Medicine (CVM) to address
including attachments, to http:// for public viewing and posted on http:// antimicrobial resistance by taking
www.regulations.gov will be posted to www.regulations.gov. Submit both measures to ensure the judicious use of
the docket unchanged. Because your copies to the Division of Dockets antimicrobial drugs in animal
comment will be made public, you are Management. If you do not wish your agriculture. Under this program,
solely responsible for ensuring that your name and contact information to be sponsors of antimicrobial new animal
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Document Created: 2016-08-24 03:02:41
Document Modified: 2016-08-24 03:02:41
| 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 this draft guidance before we issue the final version of the guidance, submit either electronic or written comments on the draft guidance by February 21, 2017. | |
| 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 57816 |
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