81 FR 75693 - What You Need To Know About the Food and Drug Administration Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Small Entity Compliance Guide; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 211 (November 1, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 211 (November 1, 2016)
| Page Range | 75693-75694 | |
| FR Document | 2016-26314 |
[Federal Register Volume 81, Number 211 (Tuesday, November 1, 2016)] [Rules and Regulations] [Pages 75693-75694] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26314] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 507 [Docket No. FDA-2011-N-0922] What You Need To Know About the Food and Drug Administration Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Small Entity Compliance Guide; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry #241 entitled ``What You Need To Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals''--Small Entity Compliance Guide. The small entity compliance guide (SECG) is intended to help small entities comply with the final rule titled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.'' DATES: Submit either electronic or written comments on FDA guidances at any time. 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 [[Page 75694]] 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-2011-N-0922 for ``What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.'' 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 SECG to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the SECG. FOR FURTHER INFORMATION CONTACT: Jeanette Murphy, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20800, 240-402-6246. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of September 17, 2015 (80 FR 56170), we issued a final rule entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals'' (the final rule) in which we established requirements for facilities subject to food registration to implement current good manufacturing practices and establish and implement hazard analysis and risk-based preventive controls for food for animals. The final rule, which is codified at part 507 (21 CFR part 507), became effective November 16, 2015 (except for paragraph (2) of the definition of ``qualified auditor'' in Sec. 507.3, and Sec. Sec. 507.12(a)(1)(ii), 507.105(a)(2), 507.105(c), 507.110(d)(2)(ii), 507.130(d), 507.135(d), 507.175(c)(2), and 507.175(c)(13)) but has compliance dates staggered over several years after publication of the final rule. We examined the economic implications of the final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612) and determined that the final rule will have a significant economic impact on a substantial number of small entities. In compliance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104- 121, as amended by Pub. L. 110-28), we are making available the SECG to explain the actions that a small entity must take to comply with the rule. We are issuing the SECG consistent with our good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG represents 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 alternative approach if it satisfies the requirements of the applicable statutes and regulations. 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 part 507 have been approved under 0910- 0789. III. Electronic Access Persons with access to the Internet may obtain the SECG at http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm253380.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. Dated: October 26, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-26314 Filed 10-31-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 211 / Tuesday, November 1, 2016 / Rules and Regulations 75693
sheet and not in the body of your dates staggered over several years after DEPARTMENT OF HEALTH AND
comments and you must identify this publication of the final rule. HUMAN SERVICES
information as ‘‘confidential.’’ Any We examined the economic
information marked as ‘‘confidential’’ Food and Drug Administration
implications of the final rule as required
will not be disclosed except in by the Regulatory Flexibility Act (5
accordance with 21 CFR 10.20 and other 21 CFR Part 507
U.S.C. 601–612) and determined that
applicable disclosure law. For more [Docket No. FDA–2011–N–0922]
the final rule will have a significant
information about FDA’s posting of
comments to public dockets, see 80 FR economic impact on a substantial
What You Need To Know About the
56469, September 18, 2015, or access number of small entities. In compliance
Food and Drug Administration
the information at: http://www.fda.gov/ with section 212 of the Small Business Regulation: Current Good
regulatoryinformation/dockets/ Regulatory Enforcement Fairness Act Manufacturing Practice, Hazard
default.htm. (Pub. L. 104–121, as amended by Pub. Analysis, and Risk-Based Preventive
Docket: For access to the docket to L. 110–28), we are making available the Controls for Food for Animals; Small
read background documents or the SECG to explain the actions that a small Entity Compliance Guide; Availability
electronic and written/paper comments entity must take to comply with the
rule. AGENCY: Food and Drug Administration,
received, go to http:// HHS.
www.regulations.gov and insert the We are issuing the SECG consistent
ACTION: Notification of availability.
docket number, found in brackets in the with our good guidance practices
heading of this document, into the regulation (21 CFR 10.115(c)(2)). The SUMMARY: The Food and Drug
‘‘Search’’ box and follow the prompts SECG represents the current thinking of Administration (FDA, the Agency, or
and/or go to the Division of Dockets FDA on this topic. It does not establish we) is announcing the availability of a
Management, 5630 Fishers Lane, Rm. any rights for any person and is not guidance for industry #241 entitled
1061, Rockville, MD 20852. binding on FDA or the public. You can ‘‘What You Need To Know About the
Submit written requests for single use an alternative approach if it satisfies FDA Regulation: Current Good
copies of the SECG to the Office of Food the requirements of the applicable Manufacturing Practice, Hazard
Safety, Center for Food Safety and statutes and regulations. Analysis, and Risk-Based Preventive
Applied Nutrition, Food and Drug Controls for Food for Animals’’—Small
Administration, 5001 Campus Dr., II. Paperwork Reduction Act of 1995 Entity Compliance Guide. The small
College Park, MD 20740. Send two self- entity compliance guide (SECG) is
This guidance refers to previously
addressed adhesive labels to assist that intended to help small entities comply
approved collections of information with the final rule titled ‘‘Current Good
office in processing your request. See
the SUPPLEMENTARY INFORMATION section found in FDA regulations. These Manufacturing Practice, Hazard
for electronic access to the SECG. collections of information are subject to Analysis, and Risk-Based Preventive
review by the Office of Management and Controls for Food for Animals.’’
FOR FURTHER INFORMATION CONTACT: Budget (OMB) under the Paperwork
Jenny Scott, Center for Food Safety and DATES: Submit either electronic or
Reduction Act of 1995 (44 U.S.C. 3501– written comments on FDA guidances at
Applied Nutrition, Food and Drug 3520). The collections of information in
Administration, 5001 Campus Dr., any time.
21 CFR part 117 have been approved ADDRESSES: You may submit comments
College Park, MD 20740, 240–402–1700.
under OMB control number 0910–0751. as follows:
SUPPLEMENTARY INFORMATION:
III. Electronic Access Electronic Submissions
I. Background
Persons with access to the Internet Submit electronic comments in the
In the Federal Register of September may obtain the SECG at either http:// following way:
17, 2015 (80 FR 55908), we issued a www.fda.gov/FoodGuidances, or http:// • Federal eRulemaking Portal: http://
final rule titled ‘‘Current Good www.regulations.gov. Use the FDA Web www.regulations.gov. Follow the
Manufacturing Practice, Hazard instructions for submitting comments.
site listed in the previous sentence to
Analysis, and Risk-Based Preventive Comments submitted electronically,
find the most current version of the
Controls for Human Food’’ (the final including attachments, to http://
rule) in which we modernized the guidance.
www.regulations.gov will be posted to
longstanding current good Dated: October 26, 2016. the docket unchanged. Because your
manufacturing practice requirements in Leslie Kux, comment will be made public, you are
21 CFR part 110 and added the Associate Commissioner for Policy. solely responsible for ensuring that your
requirements for facilities subject to [FR Doc. 2016–26315 Filed 10–31–16; 8:45 am] comment does not include any
registration to establish and implement confidential information that you or a
BILLING CODE 4164–01–P
hazard analysis and risk-based third party may not wish to be posted,
preventive controls for human food. The such as medical information, your or
final rule, which is codified at part 117 anyone else’s Social Security number, or
(21 CFR part 117), became effective confidential business information, such
November 16, 2015 (except for the as a manufacturing process. Please note
amendment to part 110 in instruction that if you include your name, contact
jstallworth on DSK7TPTVN1PROD with RULES
13, which is effective September 17, information, or other information that
2018, and paragraph (2) of the definition identifies you in the body of your
of ‘‘qualified auditor’’ in § 117.3, and comments, that information will be
§§ 117.5(k)(2), 117.8, 117.405(a)(2), posted on http://www.regulations.gov.
117.405(c), 117.410(d)(2)(ii), 117.430(d), • If you want to submit a comment
117.435(d), 117.475(c)(2), and with confidential information that you
117.475(c)(13)) but has compliance do not wish to be made available to the
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![75694 Federal Register / Vol. 81, No. 211 / Tuesday, November 1, 2016 / Rules and Regulations
public, submit the comment as a 56469, September 18, 2015, or access SECG to explain the actions that a small
written/paper submission and in the the information at: http://www.fda.gov/ entity must take to comply with the
manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/ rule.
Submissions’’ and ‘‘Instructions’’). default.htm. We are issuing the SECG consistent
Docket: For access to the docket to with our good guidance practices
Written/Paper Submissions
read background documents or the regulation (21 CFR 10.115(c)(2)). The
Submit written/paper submissions as electronic and written/paper comments SECG represents the current thinking of
follows: received, go to http:// FDA on this topic. It does not establish
• Mail/Hand delivery/Courier (for www.regulations.gov and insert the any rights for any person and is not
written/paper submissions): Division of docket number, found in brackets in the binding on FDA or the public. You can
Dockets Management (HFA–305), Food heading of this document, into the use an alternative approach if it satisfies
and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts the requirements of the applicable
Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets statutes and regulations.
• For written/paper comments Management, 5630 Fishers Lane, Rm.
submitted to the Division of Dockets II. Paperwork Reduction Act of 1995
1061, Rockville, MD 20852.
Management, FDA will post your Submit written requests for single This draft guidance refers to
comment, as well as any attachments, copies of the SECG to the Policy and previously approved collections of
except for information submitted, Regulations Staff (HFV–6), Center for information found in FDA regulations.
marked and identified, as confidential, Veterinary Medicine, Food and Drug These collections of information are
if submitted as detailed in subject to review by the Office of
Administration, 7519 Standish Pl.,
‘‘Instructions.’’ Management and Budget (OMB) under
Rockville, MD 20855. Send two self-
Instructions: All submissions received
addressed adhesive labels to assist that the Paperwork Reduction Act of 1995
must include the Docket No. FDA–
office in processing your request. See (44 U.S.C. 3501–3520). The collections
2011–N–0922 for ‘‘What You Need to
the SUPPLEMENTARY INFORMATION section of information in part 507 have been
Know About the FDA Regulation:
for electronic access to the SECG. approved under 0910–0789.
Current Good Manufacturing Practice,
Hazard Analysis, and Risk-Based FOR FURTHER INFORMATION CONTACT: III. Electronic Access
Preventive Controls for Food for Jeanette Murphy, Center for Veterinary
Medicine (HFV–200), Food and Drug Persons with access to the Internet
Animals.’’ Received comments will be
Administration, 7519 Standish Pl., may obtain the SECG at http://
placed in the docket and, except for
Rockville, MD 20800, 240–402–6246. www.fda.gov/AnimalVeterinary/
those submitted as ‘‘Confidential
GuidanceComplianceEnforcement/
Submissions,’’ publicly viewable at SUPPLEMENTARY INFORMATION:
GuidanceforIndustry/default.htm,
http://www.regulations.gov or at the
I. Background http://www.fda.gov/Food/
Division of Dockets Management
In the Federal Register of September GuidanceRegulation/FSMA/
between 9 a.m. and 4 p.m., Monday
17, 2015 (80 FR 56170), we issued a ucm253380.htm, or http://
through Friday.
• Confidential Submissions—To final rule entitled ‘‘Current Good www.regulations.gov. Use the FDA Web
submit a comment with confidential Manufacturing Practice, Hazard site listed in the previous sentence to
information that you do not wish to be Analysis, and Risk-Based Preventive find the most current version of the
made publicly available, submit your Controls for Food for Animals’’ (the guidance.
comments only as a written/paper final rule) in which we established Dated: October 26, 2016.
submission. You should submit two requirements for facilities subject to Leslie Kux,
copies total. One copy will include the food registration to implement current Associate Commissioner for Policy.
information you claim to be confidential good manufacturing practices and [FR Doc. 2016–26314 Filed 10–31–16; 8:45 am]
with a heading or cover note that states establish and implement hazard BILLING CODE 4164–01–P
‘‘THIS DOCUMENT CONTAINS analysis and risk-based preventive
CONFIDENTIAL INFORMATION’’. The controls for food for animals. The final
Agency will review this copy, including rule, which is codified at part 507 (21 DEPARTMENT OF HOMELAND
the claimed confidential information, in CFR part 507), became effective SECURITY
its consideration of comments. The November 16, 2015 (except for
second copy, which will have the paragraph (2) of the definition of Coast Guard
claimed confidential information ‘‘qualified auditor’’ in § 507.3, and
redacted/blacked out, will be available §§ 507.12(a)(1)(ii), 507.105(a)(2), 33 CFR Part 165
for public viewing and posted on http:// 507.105(c), 507.110(d)(2)(ii), 507.130(d),
www.regulations.gov. Submit both 507.135(d), 507.175(c)(2), and [Docket No. USCG–2016–0936]
copies to the Division of Dockets 507.175(c)(13)) but has compliance
Safety Zone; Delaware River,
Management. If you do not wish your dates staggered over several years after
Philadelphia, PA
name and contact information to be publication of the final rule.
made publicly available, you can We examined the economic AGENCY: Coast Guard, DHS.
provide this information on the cover implications of the final rule as required ACTION: Notice of enforcement of
sheet and not in the body of your by the Regulatory Flexibility Act (5 regulation.
comments and you must identify this U.S.C. 601–612) and determined that
jstallworth on DSK7TPTVN1PROD with RULES
information as ‘‘confidential.’’ Any the final rule will have a significant SUMMARY: The Coast Guard will enforce
information marked as ‘‘confidential’’ economic impact on a substantial regulations for a safety zone for an
will not be disclosed except in number of small entities. In compliance annual fireworks event in the Captain of
accordance with 21 CFR 10.20 and other with section 212 of the Small Business the Port Delaware Bay zone from 6 p.m.
applicable disclosure law. For more Regulatory Enforcement Fairness Act to 8 p.m. on November 19, 2016.
information about FDA’s posting of (Pub. L. 104–121, as amended by Pub. Enforcement of this zone is necessary
comments to public dockets, see 80 FR L. 110–28), we are making available the and intended to ensure safety of life on
VerDate Sep<11>2014 15:21 Oct 31, 2016 Jkt 241001 PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 E:\FR\FM\01NOR1.SGM 01NOR1](https://thefederalregister.org/doc/81_FR_75904/page/2.svg)
Document Created: 2016-11-01 02:36:11
Document Modified: 2016-11-01 02:36:11
| 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 | Rules and Regulations | |
| Action | Notification of availability. | |
| Dates | Submit either electronic or written comments on FDA guidances at any time. | |
| Contact | Jeanette Murphy, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20800, 240-402-6246. | |
| FR Citation | 81 FR 75693 |
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