83 FR 22193 - The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 93 (May 14, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 93 (May 14, 2018)
| Page Range | 22193-22194 | |
| FR Document | 2018-10148 |
[Federal Register Volume 83, Number 93 (Monday, May 14, 2018)] [Rules and Regulations] [Pages 22193-22194] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-10148] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 11, 16, 106, 110, 111, 112, 114, 117, 120, 123, 129, 179, 211, and 507 [Docket No. FDA-2018-D-1378] The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules: What You Need To Know About the Food and Drug Administration Regulation; 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 entitled ``The FDA Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules: What You Need to Know About the Food and Drug Administration Regulation--Small Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled ``The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification for Certain Provisions of Four Implementing Rules.'' DATES: The announcement of the guidance is published in the Federal Register on May 14, 2018. ADDRESSES: You may submit either electronic or written comments on Agency guidances 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 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-1378 for ``The FDA Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules: What You Need to Know About the Food and Drug Administration Regulation--Small Entity Compliance Guide.'' 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 [[Page 22194]] 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 guidance to Office of Food Safety, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance. FOR FURTHER INFORMATION CONTACT: For questions relating to Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food: 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 relating to Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals: Jeanette Murphy, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6246. For questions relating to Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Rebecca Buckner, Office of Foods and Veterinary Medicine, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4576. For questions relating to Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Samir Assar, Center for Food Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1636. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of August 24, 2016 (81 FR 57784), we issued a final rule entitled ``The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification for Certain Provisions of Four Implementing Rules'' (the final rule) that extended compliance dates to address concerns about the practicality of compliance with certain provisions, consider changes to the regulatory text, and better align compliance dates across the rules. The final rule became effective August 24, 2016. 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 not 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 reduce the burden of determining how to comply by further explaining and clarifying the actions that a small entity must take to comply with the rule. We are issuing this SECG consistent with our good guidance practices regulation (21 CFR 10.115(c)(2)). This 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. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This 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 1, subpart L have been approved under OMB control number 0910-0752. The collections of information in 21 CFR part 112 have been approved under OMB control number 0910-0816. III. Electronic Access Persons with access to the internet may obtain the SECG at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance. Dated: May 8, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-10148 Filed 5-11-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 93 / Monday, May 14, 2018 / Rules and Regulations 22193
Note: The text of Form Funding Portal does number.’’ from Section 1 of the Specific Agency guidances at any time as
not, and the amendments will not, appear in Instructions for Certain Items in Form follows:
the Code of Federal Regulations. MA–I and replacing with ‘‘Until EDGAR
Electronic Submissions
■ 5. Amend Form MSD (referenced in has been updated to remove the field,
enter 000–00–0000 in the in the Social Submit electronic comments in the
§ 249.1100) by deleting the text, ‘‘(b)
Security Number Field when preparing following way:
Date of Birth (c) City of Birth: (d) State
for MA–I for transmission to EDGAR.’’ • Federal eRulemaking Portal:
or Province: (e) Country:’’ and the
■ d. Note: The text of Form MA Series https://www.regulations.gov. Follow the
surrounding text boxes from Item III of
does not, and the amendments will not, instructions for submitting comments.
Schedule A of Form MSD.
appear in the Code of Federal Comments submitted electronically,
Note: The text of Form MSD does not, and including attachments, to https://
Regulations.
the amendments will not, appear in the Code www.regulations.gov will be posted to
of Federal Regulations. * * * * *
the docket unchanged. Because your
By the Commission. comment will be made public, you are
■ 6. Amend Form MA (referenced in
Section 249.1300) Dated: April 24, 2018. solely responsible for ensuring that your
by: Brent J. Fields, comment does not include any
■ a. Removing Item 1.(c)(2); Secretary. confidential information that you or a
■ b. Revising the second sentence in [FR Doc. 2018–10227 Filed 5–11–18; 8:45 am] third party may not wish to be posted,
Item 7.(b) of Schedule A and Item8.(b) BILLING CODE 8011–01–P such as medical information, your or
of Schedule B, ‘‘If not registered with anyone else’s Social Security number, or
the CRD, then enter the Social Security confidential business information, such
Number (‘‘SSN’’) or Foreign Identity DEPARTMENT OF HEALTH AND as a manufacturing process. Please note
Number; and enter the Date of Birth HUMAN SERVICES that if you include your name, contact
(‘‘DOB’’). Social security numbers, information, or other information that
foreign identity numbers, and dates of Food and Drug Administration identifies you in the body of your
birth will not be publicly comments, that information will be
disseminated.’’ to read, ‘‘If not 21 CFR Parts 1, 11, 16, 106, 110, 111, posted on https://www.regulations.gov.
registered with the CRD, enter 112, 114, 117, 120, 123, 129, 179, 211, • If you want to submit a comment
0000000.’’; and 507 with confidential information that you
■ c. Revising ‘‘(If None: SSN and DOB, do not wish to be made available to the
[Docket No. FDA–2018–D–1378] public, submit the comment as a
or Foreign ID No. and DOB)’’ in the
‘‘Individual CRD No.’’ column in written/paper submission and in the
The Food and Drug Administration manner detailed (see ‘‘Written/Paper
Schedule A–2, Schedule B–2, Schedule Food Safety Modernization Act;
A–2 of Item 4 in Schedule C, and Submissions’’ and ‘‘Instructions’’).
Extension and Clarification of
Schedule B–2 in Item 5 of Schedule C Compliance Dates for Certain Written/Paper Submissions
to read, ‘‘(If none: enter 0000000)’’; and Provisions of Four Implementing
■ d. Removing the second, third, and
Submit written/paper submissions as
Rules: What You Need To Know About follows:
fourth sub-columns entitled ‘‘SSN,’’ the Food and Drug Administration • Mail/Hand delivery/Courier (for
‘‘DOB,’’ and ‘‘Foreign ID No.,’’ Regulation; Small Entity Compliance written/paper submissions): Dockets
respectively, under the ‘‘Individual CRD Guide; Availability Management Staff (HFA–305), Food and
No.’’ column in Schedule A–2,
Drug Administration, 5630 Fishers
Schedule B–2, Schedule A–2 in Item 4 AGENCY: Food and Drug Administration,
Lane, Rm. 1061, Rockville, MD 20852.
of Schedule C, and Schedule B–2 in HHS.
• For written/paper comments
Item 5 of Schedule C. ACTION: Notification of availability. submitted to the Dockets Management
■ e. Note: The text of Form MA does
Staff, FDA will post your comment, as
not, and the amendments will not, SUMMARY: The Food and Drug
well as any attachments, except for
appear in the Code of Federal Administration (FDA, the Agency, or
information submitted, marked and
Regulations. we) is announcing the availability of a
identified, as confidential, if submitted
■ 7. Amend Form MA–I (referenced in guidance for industry entitled ‘‘The
as detailed in ‘‘Instructions.’’
Section 249.1310) FDA Food Safety Modernization Act;
Instructions: All submissions received
by: Extension and Clarification of
must include the Docket No. FDA–
■ a. Removing ‘‘Social Security No.: Compliance Dates for Certain Provisions
2018–D–1378 for ‘‘The FDA Food Safety
lllll The Social Security Number of Four Implementing Rules: What You
Modernization Act; Extension and
will not be included in publicly Need to Know About the Food and Drug
Clarification of Compliance Dates for
available versions of this form.’’ from Administration Regulation—Small
Certain Provisions of Four
Item 1.A . Entity Compliance Guide.’’ The small
Implementing Rules: What You Need to
■ b. Note: The text of Form MA–I does entity compliance guide (SECG) is
Know About the Food and Drug
not, and the amendments will not, intended to help small entities comply
Administration Regulation—Small
appear in the Code of Federal with the final rule entitled ‘‘The Food
Entity Compliance Guide.’’ Received
Regulations. and Drug Administration Food Safety
comments will be placed in the docket
■ 8. Amend the Instructions for the
Modernization Act; Extension and
and, except for those submitted as
Clarification for Certain Provisions of
nshattuck on DSK9F9SC42PROD with RULES
Form MA Series by: ‘‘Confidential Submissions,’’ publicly
■ c. Removing ‘‘Social Security Number.
Four Implementing Rules.’’
viewable at https://www.regulations.gov
A social security number is needed for DATES: The announcement of the or at the Dockets Management Staff
regulatory purposes. However, the guidance is published in the Federal between 9 a.m. and 4 p.m., Monday
version of completed Form MA–I that Register on May 14, 2018. through Friday.
will be available for viewing by the ADDRESSES: You may submit either • Confidential Submissions—To
public will not show a social security electronic or written comments on submit a comment with confidential
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![22194 Federal Register / Vol. 83, No. 93 / Monday, May 14, 2018 / Rules and Regulations
information that you do not wish to be Analysis, and Risk-Based Preventive II. Paperwork Reduction Act of 1995
made publicly available, submit your Controls for Food for Animals: Jeanette This guidance refers to previously
comments only as a written/paper Murphy, Center for Veterinary Medicine approved collections of information
submission. You should submit two (HFV–200), Food and Drug found in FDA regulations. These
copies total. One copy will include the Administration, 7519 Standish Pl., collections of information are subject to
information you claim to be confidential Rockville, MD 20855, 240–402–6246. review by the Office of Management and
with a heading or cover note that states For questions relating to Foreign Budget (OMB) under the Paperwork
‘‘THIS DOCUMENT CONTAINS Supplier Verification Programs for Reduction Act of 1995 (44 U.S.C. 3501–
CONFIDENTIAL INFORMATION.’’ The
Importers of Food for Humans and 3520). The collections of information in
Agency will review this copy, including
Animals: Rebecca Buckner, Office of 21 CFR part 117 have been approved
the claimed confidential information, in
Foods and Veterinary Medicine, Food under OMB control number 0910–0751.
its consideration of comments. The
and Drug Administration, 10903 New The collections of information in 21
second copy, which will have the
Hampshire Ave., Silver Spring, MD CFR part 507 have been approved under
claimed confidential information
20993–0002, 301–796–4576. OMB control number 0910–0789. The
redacted/blacked out, will be available
For questions relating to Standards collections of information in 21 CFR
for public viewing and posted on
https://www.regulations.gov. Submit for the Growing, Harvesting, Packing, part 1, subpart L have been approved
both copies to the Dockets Management and Holding of Produce for Human under OMB control number 0910–0752.
Staff. If you do not wish your name and Consumption: Samir Assar, Center for The collections of information in 21
contact information to be made publicly Food Safety and Applied Nutrition CFR part 112 have been approved under
available, you can provide this (HFS–317), Food and Drug OMB control number 0910–0816.
information on the cover sheet and not Administration, 5001 Campus Dr., III. Electronic Access
in the body of your comments and you College Park, MD 20740, 240–402–1636.
Persons with access to the internet
must identify this information as
SUPPLEMENTARY INFORMATION: may obtain the SECG at either https://
‘‘confidential.’’ Any information marked
www.fda.gov/FoodGuidances or https://
as ‘‘confidential’’ will not be disclosed I. Background
except in accordance with 21 CFR 10.20 www.regulations.gov. Use the FDA
and other applicable disclosure law. For In the Federal Register of August 24, website listed in the previous sentence
more information about FDA’s posting 2016 (81 FR 57784), we issued a final to find the most current version of the
of comments to public dockets, see 80 rule entitled ‘‘The Food and Drug guidance.
FR 56469, September 18, 2015, or access Administration Food Safety Dated: May 8, 2018.
the information at: https://www.gpo.gov/ Modernization Act; Extension and Leslie Kux,
fdsys/pkg/FR-2015-09-18/pdf/2015- Clarification for Certain Provisions of Associate Commissioner for Policy.
23389.pdf. Four Implementing Rules’’ (the final [FR Doc. 2018–10148 Filed 5–11–18; 8:45 am]
Docket: For access to the docket to rule) that extended compliance dates to BILLING CODE 4164–01–P
read background documents or the address concerns about the practicality
electronic and written/paper comments of compliance with certain provisions,
received, go to https:// consider changes to the regulatory text,
www.regulations.gov and insert the and better align compliance dates across DEPARTMENT OF HOMELAND
docket number, found in brackets in the the rules. The final rule became SECURITY
heading of this document, into the effective August 24, 2016. Coast Guard
‘‘Search’’ box and follow the prompts We examined the economic
and/or go to the Dockets Management implications of the final rule as required 33 CFR Part 100
Staff, 5630 Fishers Lane, Rm. 1061, by the Regulatory Flexibility Act (5
Rockville, MD 20852. [Docket Number USCG–2018–0064]
U.S.C. 601–612) and determined that
You may submit comments on any
the final rule will not have a significant RIN 1625–AA08
guidance at any time (see 21 CFR
economic impact on a substantial
10.115(g)(5)). Special Local Regulations; Sector Ohio
Submit written requests for single number of small entities. In compliance
with section 212 of the Small Business Valley Annual and Recurring Special
copies of the guidance to Office of Food Local Regulations Update
Safety, Center for Food Safety and Regulatory Enforcement Fairness Act
Applied Nutrition (HFS–300), Food and (Pub. L. 104–121, as amended by Pub. AGENCY: Coast Guard, DHS.
Drug Administration, 5001 Campus Dr., L. 110–28), we are making available the
SECG to reduce the burden of ACTION: Final rule.
College Park, MD 20740. Send two self-
addressed adhesive labels to assist that determining how to comply by further SUMMARY: The Coast Guard amends its
office in processing your request. See explaining and clarifying the actions special local regulations for recurring
the SUPPLEMENTARY INFORMATION section that a small entity must take to comply marine parades, regattas, and other
for electronic access to the guidance. with the rule. events in the Coast Guard Sector Ohio
FOR FURTHER INFORMATION CONTACT: We are issuing this SECG consistent Valley area of responsibility. This rule
For questions relating to Current Good with our good guidance practices adds 17 new recurring special local
Manufacturing Practice, Hazard regulation (21 CFR 10.115(c)(2)). This regulations, removes 9 special local
Analysis, and Risk-Based Preventive SECG represents the current thinking of regulations, and amends the name of an
nshattuck on DSK9F9SC42PROD with RULES
Controls for Human Food: Jenny Scott, FDA on this topic. It does not establish events/sponsors, dates, and/or locations
Center for Food Safety and Applied any rights for any person and is not of regulated areas for 48 recurring
Nutrition (HFS–300), Food and Drug binding on FDA or the public. You can special local regulations already listed
Administration, 5001 Campus Dr., use an alternative approach if it satisfies in the current table. This action in
College Park, MD 20740, 240–402–2166. the requirements of the applicable necessary to protect spectators,
For questions relating to Current Good statutes and regulations. This guidance participants, and vessels from the
Manufacturing Practice, Hazard is not subject to Executive Order 12866. hazards associated with annual marine
VerDate Sep<11>2014 14:43 May 11, 2018 Jkt 244001 PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 E:\FR\FM\14MYR1.SGM 14MYR1](https://thefederalregister.org/doc/83_FR_22286/page/2.svg)
Document Created: 2018-05-12 01:11:26
Document Modified: 2018-05-12 01:11:26
| 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 | The announcement of the guidance is published in the Federal Register on May 14, 2018. | |
| Contact | For questions relating to Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food: 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 | 83 FR 22193 | |
| CFR Citation | 21
CFR
1 21 CFR 106 21 CFR 11 21 CFR 110 21 CFR 111 21 CFR 112 21 CFR 114 21 CFR 117 21 CFR 120 21 CFR 123 21 CFR 129 21 CFR 16 21 CFR 179 21 CFR 211 21 CFR 507 |
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