82 FR 55503 - Sanitary Transportation of Human and Animal Food: 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 82, Issue 224 (November 22, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 224 (November 22, 2017)
| Page Range | 55503-55504 | |
| FR Document | 2017-25204 |
[Federal Register Volume 82, Number 224 (Wednesday, November 22, 2017)] [Rules and Regulations] [Pages 55503-55504] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-25204] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1 [Docket No. FDA-2013-N-0013] Sanitary Transportation of Human and Animal Food: 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 ``Sanitary Transportation of Human and Animal Food: What You Need to Know About the FDA Regulation--Small Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled ``Sanitary Transportation of Human and Animal Food.'' DATES: The announcement of the guidance is published in the Federal Register on November 22, 2017. 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 [[Page 55504]] 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-2013-N-0013 for ``Sanitary Transportation of Human and Animal Food: What You Need to Know About the FDA 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 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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. See the SUPPLEMENTARY INFORMATION section for electronic access to the SECG. FOR FURTHER INFORMATION CONTACT: Carrol Burgundy, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2158. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of April 6, 2016 (81 FR 20091), we issued a final rule entitled ``Sanitary Transportation of Human and Animal Food'' (the final rule) that establishes requirements for shippers, loaders, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure the safety of the food they transport. The final rule, which is codified at 21 CFR part 1, subpart O, became effective June 6, 2016, and has compliance dates that started April 6, 2017. 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 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 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. 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 part 1, subpart O have been approved under OMB control number 0910-0773. 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 Web site listed in the previous sentence to find the most current version of the guidance. Dated: November 16, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-25204 Filed 11-21-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 224 / Wednesday, November 22, 2017 / Rules and Regulations 55503
CBNMS, NOAA learned from U.S. Coast sanctuaries. Potential environmental DEPARTMENT OF HEALTH AND
Guard (USCG) that the discharge impacts of the decision to postpone HUMAN SERVICES
regulations had the potential to impair effectiveness are sufficiently
the operations of USCG vessels and encompassed within the impacts Food and Drug Administration
aircraft conducting law enforcement and analysis of the environmental baseline
on-water training exercises in GFNMS and the no action alternative presented 21 CFR Part 1
and CBNMS expansion areas. The USCG in that analysis. Should NOAA decide [Docket No. FDA–2013–N–0013]
supports national marine sanctuary to amend the regulations governing
management by providing routine discharges for USGS activities in Sanitary Transportation of Human and
surveillance and dedicated law CBNMS and GFNMS, any additional Animal Food: What You Need to Know
enforcement of the National Marine environmental analysis required under About the Food and Drug
Sanctuaries Act (NMSA) and sanctuary NEPA would be prepared and released Administration Regulation; Small
regulations. To ensure that the March for public comment. Entity Compliance Guide; Availability
12, 2015, rule did not undermine
USCG’s ability to perform its duties, at B. Executive Order 12866: Regulatory AGENCY: Food and Drug Administration,
that time, NOAA postponed the Impact HHS.
effectiveness of the discharge This action has been determined to be ACTION: Notification of availability.
requirements in both sanctuaries’ not significant under Executive Order
regulations with regard to USCG SUMMARY: The Food and Drug
12866. Administration (FDA, the Agency, or
activities in the expansion areas for six
months. Four additional six-month C. Executive Order 13771: Regulatory we) is announcing the availability of a
postponements of the effectiveness of Reform guidance for industry entitled ‘‘Sanitary
the discharge requirements were Transportation of Human and Animal
published in the Federal Register on This action is not expected to be an Food: What You Need to Know About
December 1, 2015 (80 FR 74985), May Executive Order 13771 regulatory action the FDA Regulation—Small Entity
31, 2016 (81 FR 34268), December 6, because this action is not significant Compliance Guide.’’ The small entity
2016 (81 FR 87803), and June 7, 2017 under Executive Order 12866. compliance guide (SECG) is intended to
(82 FR 26339) to provide adequate time help small entities comply with the
D. Administrative Procedure Act final rule entitled ‘‘Sanitary
for completion of an environmental
assessment and to determine NOAA’s The Assistant Administrator of Transportation of Human and Animal
next steps. Without further NOAA National Ocean Service (NOS) finds Food.’’
action, the discharge regulations will good cause pursuant to 5 U.S.C. DATES: The announcement of the
become effective, with regard to USCG 553(b)(B) to waive the notice and guidance is published in the Federal
activities, on December 9, 2017. comment requirements of the Register on November 22, 2017.
However, NOAA is currently Administrative Procedure Act (APA) ADDRESSES: You may submit either
considering whether, among other because this action is administrative in electronic or written comments on
things, to exempt certain USCG nature. This action postpones the Agency guidances at any time as
activities in sanctuary regulations and is effectiveness of the discharge follows:
concurrently publishing a proposed rule requirements in the regulations for
and draft environmental analysis to seek CBNMS and GFNMS in the areas added Electronic Submissions
comment on the potential exemption. to the sanctuaries’ boundaries in 2015, Submit electronic comments in the
NOAA is therefore postponing the that underwent notice and comment following way:
effectiveness of the discharge review, with regard to USCG activities • Federal eRulemaking Portal:
requirements in the expansion areas of for one year to provide adequate time https://www.regulations.gov. Follow the
both sanctuaries with regard to USCG for public scoping, completion of an instructions for submitting comments.
activities for one year until December 9, environmental assessment, and Comments submitted electronically,
2018, or 30 days after publication of a concurrent rulemaking on how to including attachments, to https://
final rule, whichever comes first, to address the USCG activities, as www.regulations.gov will be posted to
provide adequate time for completion of appropriate. The substance of the the docket unchanged. Because your
a final environmental assessment and underlying regulations currently comment will be made public, you are
final rule, as appropriate. The proposed remains unchanged. Therefore, solely responsible for ensuring that your
rule and related environmental analysis providing notice and opportunity for comment does not include any
associated with this action will give the public comment under the APA would confidential information that you or a
public, other federal agencies, and serve no useful purpose. For the reasons third party may not wish to be posted,
interested stakeholders an opportunity above, the Assistant Administrator also such as medical information, your or
to comment on various alternatives that finds good cause under 5 U.S.C. 553(d) anyone else’s Social Security number, or
are being considered. to waive the 30-day delay in confidential business information, such
II. Classification effectiveness and make this action as a manufacturing process. Please note
effective immediately upon publication. that if you include your name, contact
A. National Environmental Policy Act information, or other information that
Authority: 16 U.S.C. 1431 et seq.
NOAA previously conducted an identifies you in the body of your
Dated: November 14, 2017.
environmental analysis under the comments, that information will be
ethrower on DSK3G9T082PROD with RULES
National Environmental Policy Act Nicole R. LeBoeuf, posted on https://www.regulations.gov.
(NEPA) as part of the rulemaking Deputy Assistant Administrator for Ocean • If you want to submit a comment
process leading to the expansion of Services and Coastal Zone Management, with confidential information that you
CBNMS and GFNMS, which addressed National Ocean Service. do not wish to be made available to the
regulations regarding the discharge of [FR Doc. 2017–25104 Filed 11–21–17; 8:45 am] public, submit the comment as a
any matter or material in the BILLING CODE 3510–NK–P written/paper submission and in the
VerDate Sep<11>2014 16:22 Nov 21, 2017 Jkt 244001 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 E:\FR\FM\22NOR1.SGM 22NOR1](https://thefederalregister.org/doc/82_FR_55727/page/1.svg)
![55504 Federal Register / Vol. 82, No. 224 / Wednesday, November 22, 2017 / Rules and Regulations
manner detailed (see ‘‘Written/Paper You may submit comments on any II. Paperwork Reduction Act of 1995
Submissions’’ and ‘‘Instructions’’). guidance at any time (see 21 CFR This guidance refers to previously
10.115(g)(5)). approved collections of information
Written/Paper Submissions Docket: For access to the docket to
found in FDA regulations. These
Submit written/paper submissions as read background documents or the
collections of information are subject to
follows: electronic and written/paper comments
review by the Office of Management and
• Mail/Hand delivery/Courier (for received, go to https://
Budget (OMB) under the Paperwork
written/paper submissions): Dockets www.regulations.gov and insert the
Reduction Act of 1995 (44 U.S.C. 3501–
Management Staff (HFA–305), Food and docket number, found in brackets in the
3520). The collections of information in
Drug Administration, 5630 Fishers heading of this document, into the
part 1, subpart O have been approved
Lane, Rm. 1061, Rockville, MD 20852. ‘‘Search’’ box and follow the prompts
under OMB control number 0910–0773.
• For written/paper comments and/or go to the Dockets Management
submitted to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, III. Electronic Access
Staff, FDA will post your comment, as Rockville, MD 20852. Persons with access to the internet
well as any attachments, except for See the SUPPLEMENTARY INFORMATION may obtain the SECG at either https://
information submitted, marked and section for electronic access to the www.fda.gov/FoodGuidances or https://
identified, as confidential, if submitted SECG. www.regulations.gov. Use the FDA Web
as detailed in ‘‘Instructions.’’ FOR FURTHER INFORMATION CONTACT: site listed in the previous sentence to
Instructions: All submissions received Carrol Burgundy, Center for Food Safety find the most current version of the
must include the Docket No. FDA– and Applied Nutrition, Food and Drug guidance.
2013–N–0013 for ‘‘Sanitary Administration, 5001 Campus Dr., Dated: November 16, 2017.
Transportation of Human and Animal College Park, MD 20740, 240–402–2158. Anna K. Abram,
Food: What You Need to Know About SUPPLEMENTARY INFORMATION:
the FDA Regulation—Small Entity Deputy Commissioner for Policy, Planning,
I. Background Legislation, and Analysis.
Compliance Guide.’’ Received
comments will be placed in the docket [FR Doc. 2017–25204 Filed 11–21–17; 8:45 am]
In the Federal Register of April 6,
and, except for those submitted as 2016 (81 FR 20091), we issued a final BILLING CODE 4164–01–P
‘‘Confidential Submissions,’’ publicly rule entitled ‘‘Sanitary Transportation of
viewable at https://www.regulations.gov Human and Animal Food’’ (the final
or at the Dockets Management Staff rule) that establishes requirements for DEPARTMENT OF JUSTICE
between 9 a.m. and 4 p.m., Monday shippers, loaders, carriers by motor
through Friday. vehicle and rail vehicle, and receivers Drug Enforcement Administration
• Confidential Submissions—To engaged in the transportation of food,
submit a comment with confidential including food for animals, to use 21 CFR Part 1308
information that you do not wish to be sanitary transportation practices to [Docket No. DEA–344]
made publicly available, submit your ensure the safety of the food they
comments only as a written/paper transport. The final rule, which is Schedules of Controlled Substances:
submission. You should submit two codified at 21 CFR part 1, subpart O, Placement of FDA-Approved Products
copies total. One copy will include the became effective June 6, 2016, and has of Oral Solutions Containing
information you claim to be confidential compliance dates that started April 6, Dronabinol [(-)-delta-9-trans-
with a heading or cover note that states 2017. tetrahydrocannabinol (delta-9-THC)] in
‘‘THIS DOCUMENT CONTAINS We examined the economic Schedule II
CONFIDENTIAL INFORMATION.’’ The implications of the final rule as required
Agency will review this copy, including by the Regulatory Flexibility Act (5 AGENCY: Drug Enforcement
the claimed confidential information, in U.S.C. 601–612) and determined that Administration, Department of Justice.
its consideration of comments. The the final rule will have a significant ACTION: Final rule.
second copy, which will have the economic impact on a substantial
claimed confidential information number of small entities. In compliance SUMMARY: This final rule adopts without
redacted/blacked out, will be available with section 212 of the Small Business changes an interim final rule with
for public viewing and posted on Regulatory Enforcement Fairness Act request for comments published in the
https://www.regulations.gov. Submit (Pub. L. 104–121, as amended by Pub. Federal Register on March 23, 2017. On
both copies to the Dockets Management L. 110–28), we are making available the July 1, 2016, the U.S. Food and Drug
Staff. If you do not wish your name and SECG to reduce the burden of Administration (FDA) approved a new
contact information to be made publicly determining how to comply by further drug application for Syndros, a drug
available, you can provide this explaining and clarifying the actions product consisting of dronabinol [(-)-
information on the cover sheet and not that a small entity must take to comply delta-9-trans-tetrahydrocannabinol
in the body of your comments and you with the rule. (delta-9-THC)] oral solution. The Drug
must identify this information as We are issuing the SECG consistent Enforcement Administration (DEA)
‘‘confidential.’’ Any information marked with our good guidance practices maintains FDA-approved products of
as ‘‘confidential’’ will not be disclosed regulation (21 CFR 10.115(c)(2)). The oral solutions containing dronabinol in
except in accordance with 21 CFR 10.20 SECG represents the current thinking of schedule II of the Controlled Substances
and other applicable disclosure law. For FDA on this topic. It does not establish Act.
ethrower on DSK3G9T082PROD with RULES
more information about FDA’s posting any rights for any person and is not DATES: The effective date of this final
of comments to public dockets, see 80 binding on FDA or the public. You can rulemaking is November 22, 2017.
FR 56469, September 18, 2015, or access use an alternative approach if it satisfies FOR FURTHER INFORMATION CONTACT:
the information at: https://www.gpo.gov/ the requirements of the applicable Michael J. Lewis, Diversion Control
fdsys/pkg/FR-2015-09-18/pdf/2015- statutes and regulations. This guidance Division, Drug Enforcement
23389.pdf. is not subject to Executive Order 12866. Administration; Mailing Address: 8701
VerDate Sep<11>2014 16:22 Nov 21, 2017 Jkt 244001 PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 E:\FR\FM\22NOR1.SGM 22NOR1](https://thefederalregister.org/doc/82_FR_55727/page/2.svg)
Document Created: 2017-11-22 00:48:33
Document Modified: 2017-11-22 00:48:33
| 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 November 22, 2017. | |
| Contact | Carrol Burgundy, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2158. | |
| FR Citation | 82 FR 55503 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR