83 FR 27999 - Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 116 (June 15, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 116 (June 15, 2018)
| Page Range | 27999-28001 | |
| FR Document | 2018-12894 |
[Federal Register Volume 83, Number 116 (Friday, June 15, 2018)] [Notices] [Pages 27999-28001] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12894] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-1861] Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry #246 entitled ``Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program.'' This draft guidance document, when finalized, will help animal food facilities comply with the requirements for the supply-chain program under our regulation ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.'' DATES: Submit either electronic or written comments on the draft guidance by December 12, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 28000]] 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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-2018-D-1861 for ``Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Jenny Murphy, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6246, jenny.murphy@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables FDA to better protect public (human and animal) health by helping to ensure the safety and security of the food supply. FSMA enables FDA to focus more on preventing animal food safety problems rather than relying primarily on reacting to problems after they occur. Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act), by adding section 418 (21 U.S.C. 350g) with 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 the hazard analysis and risk-based preventive controls requirements within part 507 (21 CFR part 507). We are announcing the availability of a draft guidance for industry #246 entitled ``Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program.'' This draft guidance for industry is intended to explain how to comply with the requirements for the supply-chain program of the hazard analysis and risk-based preventive controls for food for animals under part 507. In the Federal Register of January 23, 2018 (83 FR 3163), we announced the availability of a related multichapter draft guidance for industry, #245 entitled ``Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.'' In the Federal Register of February 5, 2018 (83 FR 5106), we announced a correction to the docket number for that draft guidance. II. Significance of Guidance This level 1 draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on how to comply with the supply-chain program requirements for the regulation ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.'' It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. 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 Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 507 have been approved under OMB control number 0910-0789. IV. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance. [[Page 28001]] Dated: June 8, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-12894 Filed 6-14-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Notices 27999
except in accordance with 21 CFR 10.20 When final, this guidance will replace the collections of information in the
and other applicable disclosure law. For ‘‘Coronary and Cerebrovascular guidance document ‘‘Requests for
more information about FDA’s posting Guidewire Guidance’’ (https:// Feedback on Medical Device
of comments to public dockets, see 80 www.fda.gov/downloads/Medical Submissions: The Pre-Submission
FR 56469, September 18, 2015, or access Devices/DeviceRegulationandGuidance/ Program and Meetings with Food and
the information at: https://www.gpo.gov/ GuidanceDocuments/UCM080789.pdf) Drug Administration Staff’’ have been
fdsys/pkg/FR-2015-09-18/pdf/2015- dated January 1995. approved under OMB control number
23389.pdf. II. Significance of Guidance 0910–0756.
Docket: For access to the docket to Dated: June 8, 2018.
read background documents or the This draft guidance is being issued
consistent with FDA’s good guidance Leslie Kux,
electronic and written/paper comments
practices regulation (21 CFR 10.115). Associate Commissioner for Policy.
received, go to https://
www.regulations.gov and insert the The draft guidance, when finalized, will [FR Doc. 2018–12825 Filed 6–14–18; 8:45 am]
docket number, found in brackets in the represent the current thinking of FDA BILLING CODE 4164–01–P
heading of this document, into the on ‘‘Coronary, Peripheral and
‘‘Search’’ box and follow the prompts Neurovascular Guidewires—
and/or go to the Dockets Management Performance Tests and Recommended DEPARTMENT OF HEALTH AND
Staff, 5630 Fishers Lane, Rm. 1061, Labeling.’’ It does not establish any HUMAN SERVICES
Rockville, MD 20852. rights for any person and is not binding
on FDA or the public. You can use an Food and Drug Administration
You may submit comments on any
guidance at any time (see 21 CFR alternative approach if it satisfies the [Docket No. FDA–2018–D–1861]
10.115(g)(5)). requirements of the applicable statutes
An electronic copy of the guidance and regulations. This guidance is not Hazard Analysis and Risk-Based
document is available for download subject to Executive Order 12866. Preventive Controls for Food for
from the internet. See the Animals: Supply-Chain Program; Draft
III. Electronic Access
SUPPLEMENTARY INFORMATION section for Guidance for Industry; Availability
Persons interested in obtaining a copy
information on electronic access to the AGENCY: Food and Drug Administration,
of the draft guidance may do so by
guidance. Submit written requests for a HHS.
downloading an electronic copy from
single hard copy of the draft guidance ACTION: Notice of availability.
the internet. A search capability for all
entitled ‘‘Coronary, Peripheral, and
Center for Devices and Radiological
Neurovascular Guidewires— SUMMARY: The Food and Drug
Health guidance documents is available
Performance Tests and Recommended Administration (FDA, we, or Agency) is
at https://www.fda.gov/MedicalDevices/
Labeling’’ to the Office of the Center announcing the availability of a draft
DeviceRegulationandGuidance/
Director, Guidance and Policy guidance for industry #246 entitled
GuidanceDocuments/default.htm. This
Development, Center for Devices and ‘‘Hazard Analysis and Risk-Based
draft guidance is also available at
Radiological Health, Food and Drug Preventive Controls for Food for
https://www.regulations.gov. Persons
Administration, 10903 New Hampshire Animals: Supply-Chain Program.’’ This
unable to download an electronic copy
Ave., Bldg. 66, Rm. 5431, Silver Spring, draft guidance document, when
of ‘‘Coronary, Peripheral, and
MD 20993–0002. Send one self- finalized, will help animal food
Neurovascular Guidewires—
addressed adhesive label to assist that facilities comply with the requirements
Performance Tests and Recommended
office in processing your request. for the supply-chain program under our
Labeling’’ may send an email request to
FOR FURTHER INFORMATION CONTACT: CDRH-Guidance@fda.hhs.gov to receive regulation ‘‘Current Good
Jismi Johnson, Center for Devices and an electronic copy of the document. Manufacturing Practice, Hazard
Radiological Health, Food and Drug Please use the document number 16007 Analysis, and Risk-Based Preventive
Administration, 10903 New Hampshire to identify the guidance you are Controls for Food for Animals.’’
Ave., Bldg. 66, Rm. 1524, Silver Spring, requesting. DATES: Submit either electronic or
MD 20993–0002, 301–796–6424. written comments on the draft guidance
SUPPLEMENTARY INFORMATION:
IV. Paperwork Reduction Act of 1995 by December 12, 2018 to ensure that the
This draft guidance refers to Agency considers your comment on this
I. Background previously approved collections of draft guidance before it begins work on
FDA is announcing the availability of information found in FDA regulations the final version of the guidance.
a draft guidance for industry and FDA and guidance. These collections of ADDRESSES: You may submit comments
staff entitled ‘‘Coronary, Peripheral, and information are subject to review by the on any guidance at any time as follows:
Neurovascular Guidewires— Office of Management and Budget
Performance Tests and Recommended (OMB) under the Paperwork Reduction Electronic Submissions
Labeling.’’ This draft guidance updates Act of 1995 (44 U.S.C. 3501–3520). The Submit electronic comments in the
and clarifies performance testing and collections of information in 21 CFR following way:
labeling recommendations to support a part 807, subpart E have been approved • Federal eRulemaking Portal:
premarket notification (510(k) under OMB control number 0910–0120; https://www.regulations.gov. Follow the
submission) for guidewires intended for the collections of information in 21 CFR instructions for submitting comments.
use in the coronary, peripheral, and part 820 have been approved under Comments submitted electronically,
sradovich on DSK3GMQ082PROD with NOTICES
neurovasculature. This draft guidance is OMB control number 0910–0073; the including attachments, to https://
intended to assist industry in designing collections of information in 21 CFR www.regulations.gov will be posted to
and executing appropriate performance part 812 have been approved under the docket unchanged. Because your
testing to support a premarket OMB control number 0910–0078; the comment will be made public, you are
notification and provides collections of information in 21 CFR solely responsible for ensuring that your
recommendations for content and part 801 have been approved under comment does not include any
labeling to include in the submission. OMB control number 0910–0485; and confidential information that you or a
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![Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Notices 28001
Dated: June 8, 2018. Place: National Institutes of Health, 6701 Place: Edgewater Hotel, 2411 Alaskan Way,
Leslie Kux, Rockledge Drive, Bethesda, MD 20892 Pier 67, Seattle, WA 98121.
(Telephone Conference Call). Contact Person: Liangbiao Zheng, Ph.D.,
Associate Commissioner for Policy.
Contact Person: Peter B. Guthrie, Ph.D., Scientific Review Officer, Center for
[FR Doc. 2018–12894 Filed 6–14–18; 8:45 am] Scientific Review Officer, Center for Scientific Review, National Institutes of
BILLING CODE 4164–01–P Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3202,
Health, 6701 Rockledge Drive, Room 4142, MSC 7808, Bethesda, MD 20892, 301–996–
MSC 7850, Bethesda, MD 20892, (301) 435– 5819, zhengli@csr.nih.gov.
DEPARTMENT OF HEALTH AND 1239, guthriep@csr.nih.gov. Name of Committee: Center for Scientific
HUMAN SERVICES (Catalogue of Federal Domestic Assistance Review Special Emphasis Panel; Member
Program Nos. 93.306, Comparative Medicine; Conflict: Psychopathology, Aging, and
National Institutes of Health 93.333, Clinical Research, 93.306, 93.333, Cognition.
93.337, 93.393–93.396, 93.837–93.844, Date: July 13, 2018.
Center for Scientific Review; Notice of 93.846–93.878, 93.892, 93.893, National Time: 1:30 p.m. to 4:00 p.m.
Closed Meetings Institutes of Health, HHS) Agenda: To review and evaluate grant
applications.
Dated: June 11, 2018.
Pursuant to section 10(d) of the Place: National Institutes of Health, 6705
Sylvia L. Neal, Rockledge Drive, Bethesda, MD 20817
Federal Advisory Committee Act, as
Program Analyst, Office of Federal Advisory (Telephone Conference Call).
amended, notice is hereby given of the Committee Policy. Contact Person: Maribeth Champoux,
following meetings. Ph.D., Scientific Review Officer, Center for
[FR Doc. 2018–12836 Filed 6–14–18; 8:45 am]
The meetings will be closed to the Scientific Review, National Institutes of
BILLING CODE 4140–01–P
public in accordance with the Health, 6701 Rockledge Drive, Room 3170,
provisions set forth in sections MSC 7848, Bethesda, MD 20892, 301–594–
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 3163, champoum@csr.nih.gov.
DEPARTMENT OF HEALTH AND
as amended. The grant applications and Name of Committee: Center for Scientific
HUMAN SERVICES
the discussions could disclose Review Special Emphasis Panel; Member
confidential trade secrets or commercial Conflict: Topics in Drug Resistance, Drug
National Institutes of Health Discovery and Clinical and Field Research.
property such as patentable material, Date: July 16–17, 2018.
and personal information concerning Center for Scientific Review; Notice of Time: 8:00 a.m. to 6:00 p.m.
individuals associated with the grant Closed Meetings Agenda: To review and evaluate grant
applications, the disclosure of which Pursuant to section 10(d) of the applications.
would constitute a clearly unwarranted Federal Advisory Committee Act, as
Place: National Institutes of Health, 6701
invasion of personal privacy. Rockledge Drive, Bethesda, MD 20892
amended (5 U.S.C. App.), notice is (Virtual Meeting).
Name of Committee: Center for Scientific hereby given of the following meetings. Contact Person: Tera Bounds, DVM, Ph.D.,
Review Special Emphasis Panel; The meetings will be closed to the Scientific Review Officer, Center for
Fellowships: Musculoskeletal and Oral public in accordance with the Scientific Review, National Institutes of
Sciences, Imaging, Surgery and Informatics. provisions set forth in sections Health, 6701 Rockledge Drive, Room 3214,
Date: July 10–11, 2018. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., MSC 7808, Bethesda, MD 20892, 301–435–
Time: 8:00 a.m. to 5:00 p.m. 2306, boundst@csr.nih.gov.
Agenda: To review and evaluate grant
as amended. The grant applications and
the discussions could disclose Name of Committee: Center for Scientific
applications. Review Special Emphasis Panel; Topics in
Place: Residence Inn Bethesda, 7335 confidential trade secrets or commercial
Bacterial Pathogenesis.
Wisconsin Avenue, Bethesda, MD 20814. property such as patentable material,
Date: July 16, 2018.
Contact Person: Anshumali Chaudhari, and personal information concerning Time: 8:00 a.m. to 6:00 p.m.
Ph.D., Scientific Review Officer, Center for individuals associated with the grant Agenda: To review and evaluate grant
Scientific Review, National Institutes of applications, the disclosure of which applications.
Health, 6701 Rockledge Drive, Room 4124, would constitute a clearly unwarranted Place: Hotel Zoe Fisherman’s Wharf, 425
MSC 7802, Bethesda, MD 20892, (301) 435– invasion of personal privacy. North Point, San Francisco, CA 94133.
1210, chaudhaa@csr.nih.gov. Contact Person: Richard G. Kostriken,
Name of Committee: Center for Scientific
Name of Committee: Center for Scientific Ph.D., Scientific Review Officer, Center for
Review Special Emphasis Panel; Member
Review Special Emphasis Panel; Platforms to Scientific Review, National Institutes of
Conflict: Neurodevelopment and Psychiatric
Evaluate Adverse Biological Consequences of Health, 6701 Rockledge Drive, Room 3192,
Disorders.
Cell Genome Editing. MSC 7808, Bethesda, MD 20892, 240–519–
Date: June 27–28, 2018.
Date: July 10, 2018. Time: 8:00 a.m. to 8:00 p.m. 7808, kostrikr@csr.nih.gov.
Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant Name of Committee: Center for Scientific
Agenda: To review and evaluate grant applications. Review Special Emphasis Panel; Member
applications. Place: National Institutes of Health, 6701 Conflict: Gastrointestinal and Pancreatic
Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 Physiopathology.
Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Date: July 16, 2018.
(Virtual Meeting). Contact Person: Samuel C. Edwards, Ph.D., Time: 1:00 p.m. to 4:00 p.m.
Contact Person: Methode Bacanamwo, Chief, Brain Disorders and Clinical Agenda: To review and evaluate grant
Ph.D., Scientific Review Officer, Center for Neuroscience, Center for Scientific Review, applications.
Scientific Review, National Institutes of National Institutes of Health, 6701 Rockledge Place: National Institutes of Health, 6701
Health, 6701 Rockledge Drive, Room 2200, Drive, Room 5210, MSC 7846, Bethesda, MD Rockledge Drive, Bethesda, MD 20892
Bethesda, MD 20892, 301–827–7088, 20892, (301) 435–1246, edwardss@ (Telephone Conference Call).
sradovich on DSK3GMQ082PROD with NOTICES
methode.bacanamwo@nih.gov. csr.nih.gov. Contact Person: Martha Garcia, Ph.D.,
Name of Committee: Center for Scientific Name of Committee: Center for Scientific Scientific Reviewer Officer, Center for
Review Special Emphasis Panel; Member Review Special Emphasis Panel; Infectious Scientific Review, National Institutes of
Conflict: Neuropharmacology. Diseases and Microbiology AREA Review. Health, 6701 Rockledge Drive, Room 2186,
Date:.July 11, 2018. Date: July 13, 2018. MSC 7818, Bethesda, MD 20892, 301–435–
Time: 1:00 p.m. to 5:00 p.m. Time: 8:00 a.m. to 5:00 p.m. 1243, garciamc@nih.gov.
Agenda: To review and evaluate grant Agenda: To review and evaluate grant Name of Committee: Center for Scientific
applications. applications. Review Special Emphasis Panel; Member
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Document Created: 2018-11-02 12:00:29
Document Modified: 2018-11-02 12:00:29
| 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 | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by December 12, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Jenny Murphy, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6246, [email protected] | |
| FR Citation | 83 FR 27999 |
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