82 FR 51345 - Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food: Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 213 (November 6, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 213 (November 6, 2017)
| Page Range | 51345-51347 | |
| FR Document | 2017-24098 |
[Federal Register Volume 82, Number 213 (Monday, November 6, 2017)] [Rules and Regulations] [Pages 51345-51347] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24098] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 117, and 507 [Docket No. FDA-2017-D-5996] Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food: Guidance for Industry; 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 ``Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food.'' The guidance announces that we do not intend to take enforcement action against a receiving facility that is a co-manufacturer and that is not in compliance with certain supply-chain program requirements in the ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food'' and ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals'' regulations (preventive controls regulations) for food manufactured for the brand owner, under certain circumstances, until November 6, 2019. Furthermore, we do not intend to take enforcement action under the Foreign Supplier Verification Programs (FSVP) regulation against an importer whose supply-chain program is subject to enforcement discretion under the preventive controls regulations until November 6, 2019. DATES: The announcement of the guidance is published in the Federal Register on November 6, 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 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-2017-D-5996 for ``Supply-Chain Program Requirements and Co- [[Page 51346]] Manufacturer Supplier Approval and Verification for Human Food and Animal Food.'' 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 21CFR 10.115(g)(5)). Submit written requests for single copies of the guidance to the 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 the guidance as it applies to 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 the guidance as it applies to animal food: Jeanette Murphy, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240- 402-6246. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a guidance for industry entitled ``Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food: Guidance for Industry.'' We are issuing this guidance consistent with our good guidance practices (GGP) regulation (Sec. 10.115 (21 CFR 10.115)). We are implementing this guidance without prior public comment because we have determined that prior public participation is not feasible or appropriate (Sec. 10.115(g)(2)). We made this determination because the guidance represents a less burdensome policy consistent with the public health. Although this guidance document is immediately in effect, it remains subject to comment in accordance with FDA's GGP regulation. This guidance is not subject to Executive Order 12866. The guidance is intended for persons who participate in certain ``co-manufacturing'' agreements in the production of human or animal food. By ``co-manufacturing,'' we mean a contractual arrangement whereby one party (the brand owner) arranges for a second party (the co-manufacturer) to manufacture/process human or animal food on behalf of the first party. The guidance concerns three regulations that we have established in Title 21 of the Code of Federal Regulations (21 CFR) as part of our implementation of the FDA Food Safety Modernization Act (FSMA; Pub. L. 111-353). (For more information on the Agency's implementation of FSMA, see https://www.fda.gov/fsma.) These three regulations are part 117 (21 CFR part 117) (published in the Federal Register on September 17, 2015, 80 FR 55908), part 507 (21 CFR part 507) (published in the Federal Register on September 17, 2015, 80 FR 56170), and the FSVP regulation (published in the Federal Register of November 27, 2015, 80 FR 74226). Subpart G of part 117 and subpart E of part 507 establish requirements for a supply-chain program for those raw materials and other ingredients for which a receiving facility has identified a hazard requiring a supply-chain-applied control. Under the FSVP regulation, importers are required to develop, maintain, and follow a foreign supplier verification program that, among other things, provides adequate assurance that foreign suppliers are producing food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350g) (which authorized the supply-chain programs in parts 117 and 507) (see Sec. 1.502(a) (21 CFR 1.502(a)). An importer that is a receiving facility subject to section 418 of the FD&C Act is deemed to be in compliance with the requirements of the FSVP regulation, except the importer identification requirements in 21 CFR 1.509, if the importer has established and implemented a risk-based supply-chain program in compliance with part 117, subpart G or part 507, subpart E (Sec. 1.502(c)(3)). Under the definition of ``receiving facility'' established in parts 117 and 507, co-manufacturers that are subject to the human food or the animal food preventive controls requirements and that manufacture/ process a raw material or other ingredient received from a supplier are receiving facilities. Co-manufacturers that are receiving facilities that have identified a hazard in a raw material or ingredient requiring a supply-chain-applied control are required to approve their suppliers for those raw materials or other ingredients. However, the supply-chain provisions permit an entity other than the receiving facility (e.g., permit the brand owner) to determine, conduct, or both determine and conduct, appropriate supplier verification activities, provided that the receiving facility documents its review and assessment of the other entity's applicable documentation. (See Sec. Sec. 117.415(a)(3) and 507.115(a)(3).) Specifically, the rules allow for a co-manufacturer to base its verification of suppliers on review of adequate documentation of the brand owner's supplier verification activities. Industry has expressed concerns that the requirements of the supply-chain program would require revisions to contracts between brand owners and their suppliers to allow brand owners to share certain information (e.g., audits of suppliers) with co-manufacturers, and that establishing new contracts would take a significant period of time, impeding their ability to meet [[Page 51347]] compliance dates (Ref. 1). If a contract prevents a co-manufacturer from being able to review a brand owner's documentation of supplier verification activities, the co-manufacturer would not be able to verify suppliers based on its review of that documentation. Consequently, the co-manufacturer would need to conduct supplier verification activities (e.g., on-site audits) that might otherwise not be required. To provide time for contracts to be revised to allow co- manufacturers to review all necessary documentation from the brand owner, FDA is announcing that, under certain circumstances and on a temporary basis, we do not intend to take enforcement action against a receiving facility that is a co-manufacturer, and that is not in compliance with certain supply-chain program requirements (Sec. Sec. 117.410(d) and 117.415(a)(3) or Sec. Sec. 507.110(d) and 507.115(a)(3)) for food manufactured for the brand owner until November 6, 2019. Furthermore, we do not intend to take enforcement action under the FSVP regulation against an importer who is relying on Sec. 1.502(c)(3) but whose supply-chain program is subject to enforcement discretion regarding Sec. Sec. 117.410(d) and 117.415(a)(3) or Sec. Sec. 507.110(d) and 507.115(a)(3). The guidance 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 statues and regulations. 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 117 have been approved under OMB control number 0910-0751. The collections of information in part 507 have been approved under OMB control number 0910-0789. III. Electronic Access Persons with access to the internet may obtain the document at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/default.htm, https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/default.htm, or https://www.regulations.gov. Use the FDA Web sites listed in the previous sentence to find the most current version of the guidance. IV. Reference The following reference is on display in the Dockets Management Staff (see ADDRESSES) and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at https://www.regulations.gov. 1. Letter from Grocery Manufacturers Association to Dr. Stephen Ostroff, Acting Commissioner of Food and Drugs, February 7, 2017. Dated: October 31, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-24098 Filed 11-3-17; 8:45 am] BILLING CODE 4164-01-P
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airspace action makes minor updates to Boundaries. Beginning at lat. 34°38′35″ N., circumstances, until November 6, 2019.
certain boundary coordinates of long. 120°31′24″ W.; Furthermore, we do not intend to take
restricted areas R–2516, R–2517, R– to lat. 34°35′45″ N., long. 120°28′14″ W.; enforcement action under the Foreign
2534A and R–2534B; Vandenberg AFB, to lat. 34°36′20″ N., long. 120°27′24″ W.; Supplier Verification Programs (FSVP)
to lat. 34°30′00″ N., long. 120°15′34″ W.;
CA, to match the digital shoreline data to lat. 34°25′00″ N., long. 120°15′34″ W.;
regulation against an importer whose
received from the NOAA thence 3 NM from and parallel to the supply-chain program is subject to
Administration. This ensures that the shoreline enforcement discretion under the
affected boundaries continue to match to lat. 34°24′39″ N., long. 120°19′13″ W.; preventive controls regulations until
the NOAA-defined position of the U.S. to the point of beginning. November 6, 2019.
shoreline. It does not alter the location, R–2534B Vandenberg AFB, CA [Amended] DATES: The announcement of the
altitudes, or activities conducted within guidance is published in the Federal
the airspace; therefore, it is not expected By removing the current boundaries and
inserting the following: Register on November 6, 2017.
to cause any potentially significant Boundaries. Beginning at lat. 34°38′35″ N., ADDRESSES: You may submit either
environmental impacts, and no long. 120°31′24″ W.; electronic or written comments on
extraordinary circumstances exist that to lat. 34°24′39″ N., long. 120°19′13″ W.; Agency guidances at any time as
warrant preparation of an to lat. 34°25′00″ N., long. 120°27′04″ W.; follows:
environmental assessment. to lat. 34°35′00″ N., long. 120°32′04″ W.;
to the point of beginning. Electronic Submissions
List of Subjects in 14 CFR Part 73
* * * * * Submit electronic comments in the
Airspace, Prohibited areas, Restricted
Issued in Washington, DC, on October 31, following way:
areas.
2017. • Federal eRulemaking Portal:
Adoption of the Amendment Rodger A. Dean, Jr., https://www.regulations.gov. Follow the
In consideration of the foregoing, the Manager, Airspace Policy Group. instructions for submitting comments.
Federal Aviation Administration [FR Doc. 2017–24103 Filed 11–3–17; 8:45 am] Comments submitted electronically,
amends 14 CFR part 73, as follows: BILLING CODE 4910–13–P
including attachments, to https://
www.regulations.gov will be posted to
PART 73—SPECIAL USE AIRSPACE the docket unchanged. Because your
comment will be made public, you are
DEPARTMENT OF HEALTH AND
■ 1. The authority citation for part 73 solely responsible for ensuring that your
HUMAN SERVICES
continues to read as follows: comment does not include any
Authority: 49 U.S.C. 106(f), 106(g), 40103, Food and Drug Administration confidential information that you or a
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, third party may not wish to be posted,
1959–1963 Comp., p. 389. 21 CFR Parts 1, 117, and 507 such as medical information, your or
anyone else’s Social Security number, or
§ 73.25 [Amended] [Docket No. FDA–2017–D–5996] confidential business information, such
■ 2. Section 73.25 is amended as as a manufacturing process. Please note
Supply-Chain Program Requirements
follows: that if you include your name, contact
and Co-Manufacturer Supplier
* * * * * information, or other information that
Approval and Verification for Human
identifies you in the body of your
R–2516 Vandenberg AFB, CA [Amended] Food and Animal Food: Guidance for
comments, that information will be
By removing the current boundaries and Industry; Availability
posted on https://www.regulations.gov.
inserting the following: AGENCY: Food and Drug Administration, • If you want to submit a comment
Boundaries. Beginning at lat. 35°00′06″ N., with confidential information that you
long. 120°42′12″ W.;
HHS.
to lat. 34°54′00″ N., long. 120°33′04″ W.; ACTION: Notification of availability. do not wish to be made available to the
to lat. 34°50′00″ N., long. 120°32′04″ W.; public, submit the comment as a
to lat. 34°46′00″ N., long. 120°27′04″ W.; SUMMARY: The Food and Drug written/paper submission and in the
to lat. 34°42′00″ N., long. 120°30′04″ W.; Administration (FDA, the Agency, or manner detailed (see ‘‘Written/Paper
to lat. 34°38′35″ N., long. 120°31′24″ W.; we) is announcing the availability of a Submissions’’ and ‘‘Instructions’’).
to lat. 34°42′00″ N., long. 120°34′34″ W.; guidance for industry entitled ‘‘Supply-
to lat. 34°42′00″ N., long. 120°40′01″ W.; Chain Program Requirements and Co- Written/Paper Submissions
thence 3 NM from and parallel to the Manufacturer Supplier Approval and Submit written/paper submissions as
shoreline to the point of beginning. Verification for Human Food and follows:
R–2517 Vandenberg AFB, CA [Amended] Animal Food.’’ The guidance announces • Mail/Hand delivery/Courier (for
By removing the current boundaries and that we do not intend to take written/paper submissions): Dockets
inserting the following: enforcement action against a receiving Management Staff (HFA–305), Food and
Boundaries. Beginning at lat. 34°42′00″ N., facility that is a co-manufacturer and Drug Administration, 5630 Fishers
long. 120°40′01″ W.; that is not in compliance with certain Lane, Rm. 1061, Rockville, MD 20852.
to lat. 34°42′00″ N., long. 120°34′34″ W.; supply-chain program requirements in • For written/paper comments
to lat. 34°38′35″ N., long. 120°31′24″ W.; the ‘‘Current Good Manufacturing submitted to the Dockets Management
to lat. 34°35′00″ N., long. 120°32′04″ W.; Practice, Hazard Analysis, and Risk- Staff, FDA will post your comment, as
to lat. 34°25′00″ N., long. 120°27′04″ W.; Based Preventive Controls for Human well as any attachments, except for
Pmangrum on DSK3GDR082PROD with RULES
to lat. 34°24′04″ N., long. 120°29′51″ W.;
thence 3 NM from and parallel to the
Food’’ and ‘‘Current Good information submitted, marked and
shoreline to the point of beginning. Manufacturing Practice, Hazard identified, as confidential, if submitted
Analysis, and Risk-Based Preventive as detailed in ‘‘Instructions.’’
* * * * *
Controls for Food for Animals’’ Instructions: All submissions received
R–2534A Vandenberg AFB, CA [Amended] regulations (preventive controls must include the Docket No. FDA–
By removing the current boundaries and regulations) for food manufactured for 2017–D–5996 for ‘‘Supply-Chain
inserting the following: the brand owner, under certain Program Requirements and Co-
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compliance dates (Ref. 1). If a contract find the most current version of the Folder on the line associated with this
prevents a co-manufacturer from being guidance. rule.
able to review a brand owner’s
IV. Reference FOR FURTHER INFORMATION CONTACT: If
documentation of supplier verification
The following reference is on display you have questions on this rule, call or
activities, the co-manufacturer would
in the Dockets Management Staff (see email Petty Officer Edmund Ofalt,
not be able to verify suppliers based on
ADDRESSES) and is available for viewing
Waterways Management Branch, U.S.
its review of that documentation.
by interested persons between 9 a.m. Coast Guard Sector Delaware Bay;
Consequently, the co-manufacturer
and 4 p.m., Monday through Friday; it telephone (215) 271–4814, email
would need to conduct supplier
is also available electronically at https:// Edmund.J.Ofalt@uscg.mil.
verification activities (e.g., on-site
audits) that might otherwise not be www.regulations.gov. SUPPLEMENTARY INFORMATION:
required. 1. Letter from Grocery Manufacturers I. Table of Abbreviations
To provide time for contracts to be Association to Dr. Stephen Ostroff,
revised to allow co-manufacturers to Acting Commissioner of Food and Drugs, CFR Code of Federal Regulations
review all necessary documentation February 7, 2017. COTP Captain of the Port
from the brand owner, FDA is Dated: October 31, 2017. DHS Department of Homeland Security
announcing that, under certain FR Federal Register
Anna K. Abram,
circumstances and on a temporary basis, NPRM Notice of proposed rulemaking
Deputy Commissioner for Policy, Planning, § Section
we do not intend to take enforcement Legislation, and Analysis. U.S.C. United States Code
action against a receiving facility that is [FR Doc. 2017–24098 Filed 11–3–17; 8:45 am]
a co-manufacturer, and that is not in BILLING CODE 4164–01–P
II. Background Information and
compliance with certain supply-chain Regulatory History
program requirements (§§ 117.410(d)
and 117.415(a)(3) or §§ 507.110(d) and The Coast Guard is issuing this
507.115(a)(3)) for food manufactured for DEPARTMENT OF HOMELAND temporary rule without prior notice and
the brand owner until November 6, SECURITY opportunity to comment pursuant to
2019. Furthermore, we do not intend to authority under section 4(a) of the
Coast Guard Administrative Procedure Act (APA) (5
take enforcement action under the FSVP
regulation against an importer who is U.S.C. 553(b)). This provision
33 CFR Part 165 authorizes an agency to issue a rule
relying on § 1.502(c)(3) but whose
supply-chain program is subject to [Docket Number USCG–2017–1011] without prior notice and opportunity to
enforcement discretion regarding comment when the agency for good
RIN 1625–AA00
§§ 117.410(d) and 117.415(a)(3) or cause finds that those procedures are
§§ 507.110(d) and 507.115(a)(3). Safety Zone, Delaware River; Pipeline ‘‘impracticable, unnecessary, or contrary
The guidance represents the current Removal to the public interest.’’ Under 5 U.S.C.
thinking of FDA on this topic. It does 553(b)(B), the Coast Guard finds that
not establish any rights for any person AGENCY: Coast Guard, DHS. good cause exists for not publishing a
and is not binding on FDA or the public. ACTION: Temporary final rule. notice of proposed rulemaking (NPRM)
You can use an alternative approach if with respect to this rule due to the short
it satisfies the requirements of the SUMMARY: The Coast Guard is time period between when Sector
applicable statues and regulations. establishing temporary safety zones in Delaware Bay received complete details
the Mifflin Range on the Delaware River of this project, October 20, 2017, and the
II. Paperwork Reduction Act of 1995 to facilitate pipeline removal in date when these safety zones needed to
This guidance refers to previously preparation for the deepening of the go into effect by. It is impracticable and
approved collections of information Delaware River. The safety zones will be contrary to the public interest to publish
found in FDA regulations. These established for the waters in the vicinity an NPRM to provide a notice and
collections of information are subject to of the dredge, dredge equipment, dive opportunity for comment period
review by the Office of Management and operations, and pipe removal because the safety zones must be
Budget (OMB) under the Paperwork operations. This regulation is necessary established by November 6, 2017 to
Reduction Act of 1995 (44 U.S.C. 3501– to provide for the safety of life on ensure safety of life on navigable waters
3520). The collections of information in navigable waters of the Delaware River in the vicinity of dredging operations,
part 117 have been approved under in the vicinity of pipeline removal underwater cutting operations, and
OMB control number 0910–0751. The operations and to protect mariners from pipeline removal operations and to
collections of information in part 507 the hazards associated with dredging protect mariners from hazards
have been approved under OMB control and pipeline removal operations. Entry associated with the same.
number 0910–0789. of vessels or persons into these zones is Under 5 U.S.C. 553(d)(3), the Coast
prohibited unless specifically Guard finds that good cause exists for
III. Electronic Access authorized by the Captain of the Port making this rule effective less than 30
Persons with access to the internet Delaware Bay. days after publication in the Federal
may obtain the document at https:// DATES: This rule is effective from Register. Delaying the effective date of
www.fda.gov/Food/Guidance November 6, 2017, through December 4, this rule would be impracticable and
Pmangrum on DSK3GDR082PROD with RULES
Regulation/GuidanceDocuments 2017. contrary to the public interest because
RegulatoryInformation/default.htm, ADDRESSES: To view documents immediate action is needed to mitigate
https://www.fda.gov/AnimalVeterinary/ mentioned in this preamble as being the hazards presented to safety of life on
GuidanceComplianceEnforcement/ available in the docket, go to http:// the Delaware River by the presence of
default.htm, or https:// www.regulations.gov, type USCG–2017– dredge equipment, dredging operations,
www.regulations.gov. Use the FDA Web 1011 in the ‘‘SEARCH’’ box and click dive operations, and pipeline removal
sites listed in the previous sentence to ‘‘SEARCH.’’ Click on Open Docket operations.
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Document Created: 2017-11-07 10:30:37
Document Modified: 2017-11-07 10:30:37
| 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 6, 2017. | |
| Contact | For questions relating to the guidance as it applies to 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 | 82 FR 51345 | |
| CFR Citation | 21
CFR
1 21 CFR 117 21 CFR 507 |
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