Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Rules and Regulations 51345 

airspace action makes minor updates to 

certain boundary coordinates of 

restricted areas R–2516, R–2517, R– 

2534A and R–2534B; Vandenberg AFB, 

CA, to match the digital shoreline data 

received from the NOAA 

Administration. This ensures that the 

affected boundaries continue to match 

the NOAA-defined position of the U.S. 

shoreline. It does not alter the location, 

altitudes, or activities conducted within 

the airspace; therefore, it is not expected 

to cause any potentially significant 

environmental impacts, and no 

extraordinary circumstances exist that 

warrant preparation of an 

environmental assessment. 

List of Subjects in 14 CFR Part 73 

Airspace, Prohibited areas, Restricted 

areas. 

Adoption of the Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

amends 14 CFR part 73, as follows: 

PART 73—SPECIAL USE AIRSPACE 

■ 1. The authority citation for part 73 

continues to read as follows: 

Authority: 49 U.S.C. 106(f), 106(g), 40103, 

40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 

1959–1963 Comp., p. 389. 

§ 73.25 [Amended] 

■ 2. Section 73.25 is amended as 

follows: 

* * * * * 

R–2516 Vandenberg AFB, CA [Amended] 

By removing the current boundaries and 

inserting the following: 

Boundaries. Beginning at lat. 35°00′06′′ N., 

long. 120°42′12′′ W.; 

to lat. 34°54′00′′ N., long. 120°33′04′′ W.; 

to lat. 34°50′00′′ N., long. 120°32′04′′ W.; 

to lat. 34°46′00′′ N., long. 120°27′04′′ W.; 

to lat. 34°42′00′′ N., long. 120°30′04′′ W.; 

to lat. 34°38′35′′ N., long. 120°31′24′′ W.; 

to lat. 34°42′00′′ N., long. 120°34′34′′ W.; 

to lat. 34°42′00′′ N., long. 120°40′01′′ W.; 

thence 3 NM from and parallel to the 

shoreline to the point of beginning. 

R–2517 Vandenberg AFB, CA [Amended] 

By removing the current boundaries and 

inserting the following: 

Boundaries. Beginning at lat. 34°42′00′′ N., 

long. 120°40′01′′ W.; 

to lat. 34°42′00′′ N., long. 120°34′34′′ W.; 

to lat. 34°38′35′′ N., long. 120°31′24′′ W.; 

to lat. 34°35′00′′ N., long. 120°32′04′′ W.; 

to lat. 34°25′00′′ N., long. 120°27′04′′ W.; 

to lat. 34°24′04′′ N., long. 120°29′51′′ W.; 

thence 3 NM from and parallel to the 

shoreline to the point of beginning. 

* * * * * 

R–2534A Vandenberg AFB, CA [Amended] 

By removing the current boundaries and 

inserting the following: 

Boundaries. Beginning at lat. 34°38′35′′ N., 

long. 120°31′24′′ W.; 

to lat. 34°35′45′′ N., long. 120°28′14′′ W.; 

to lat. 34°36′20′′ N., long. 120°27′24′′ W.; 

to lat. 34°30′00′′ N., long. 120°15′34′′ W.; 

to lat. 34°25′00′′ N., long. 120°15′34′′ W.; 

thence 3 NM from and parallel to the 

shoreline 

to lat. 34°24′39′′ N., long. 120°19′13′′ W.; 

to the point of beginning. 

R–2534B Vandenberg AFB, CA [Amended] 

By removing the current boundaries and 

inserting the following: 

Boundaries. Beginning at lat. 34°38′35′′ N., 

long. 120°31′24′′ W.; 

to lat. 34°24′39′′ N., long. 120°19′13′′ W.; 

to lat. 34°25′00′′ N., long. 120°27′04′′ W.; 

to lat. 34°35′00′′ N., long. 120°32′04′′ W.; 

to the point of beginning. 

* * * * * 

Issued in Washington, DC, on October 31, 

2017. 

Rodger A. Dean, Jr., 

Manager, Airspace Policy Group. 

[FR Doc. 2017–24103 Filed 11–3–17; 8:45 am] 

BILLING CODE 4910–13–P 

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 ‘‘SupplyChain Program Requirements and CoManufacturer 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 RiskBased 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 CoVerDate Sep<11>2014 14:44 Nov 03, 2017 Jkt 244001 PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 E:\FR\FM\06NOR1.SGM 06NOR1

Pmangrum on DSK3GDR082PROD with RULES
51346 Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Rules and Regulations 

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.gpo.gov/ 

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 selfaddressed 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 (§ 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 (§ 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 ‘‘comanufacturing’’ 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 § 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 supplychain program in compliance with part 

117, subpart G or part 507, subpart E 

(§ 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. Comanufacturers 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 

§§ 117.415(a)(3) and 507.115(a)(3).) 

Specifically, the rules allow for a comanufacturer 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 


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Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Rules and Regulations 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 (§§ 117.410(d) 

and 117.415(a)(3) or §§ 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 § 1.502(c)(3) but whose 

supply-chain program is subject to 

enforcement discretion regarding 

§§ 117.410(d) and 117.415(a)(3) or 

§§ 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/Guidance

Regulation/GuidanceDocuments

RegulatoryInformation/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 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2017–1011] 

RIN 1625–AA00 

Safety Zone, Delaware River; Pipeline 

Removal 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing temporary safety zones in 

the Mifflin Range on the Delaware River 

to facilitate pipeline removal in 

preparation for the deepening of the 

Delaware River. The safety zones will be 

established for the waters in the vicinity 

of the dredge, dredge equipment, dive 

operations, and pipe removal 

operations. This regulation is necessary 

to provide for the safety of life on 

navigable waters of the Delaware River 

in the vicinity of pipeline removal 

operations and to protect mariners from 

the hazards associated with dredging 

and pipeline removal operations. Entry 

of vessels or persons into these zones is 

prohibited unless specifically 

authorized by the Captain of the Port 

Delaware Bay. 

DATES: This rule is effective from 

November 6, 2017, through December 4, 

2017. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to http://

www.regulations.gov, type USCG–2017– 

1011 in the ‘‘SEARCH’’ box and click 

‘‘SEARCH.’’ Click on Open Docket 

Folder on the line associated with this 

rule. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email Petty Officer Edmund Ofalt, 

Waterways Management Branch, U.S. 

Coast Guard Sector Delaware Bay; 

telephone (215) 271–4814, email 

Edmund.J.Ofalt@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

COTP Captain of the Port 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of proposed rulemaking 

§ Section 

U.S.C. United States Code 

II. Background Information and 

Regulatory History 

The Coast Guard is issuing this 

temporary rule without prior notice and 

opportunity to comment pursuant to 

authority under section 4(a) of the 

Administrative Procedure Act (APA) (5 

U.S.C. 553(b)). This provision 

authorizes an agency to issue a rule 

without prior notice and opportunity to 

comment when the agency for good 

cause finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ Under 5 U.S.C. 

553(b)(B), the Coast Guard finds that 

good cause exists for not publishing a 

notice of proposed rulemaking (NPRM) 

with respect to this rule due to the short 

time period between when Sector 

Delaware Bay received complete details 

of this project, October 20, 2017, and the 

date when these safety zones needed to 

go into effect by. It is impracticable and 

contrary to the public interest to publish 

an NPRM to provide a notice and 

opportunity for comment period 

because the safety zones must be 

established by November 6, 2017 to 

ensure safety of life on navigable waters 

in the vicinity of dredging operations, 

underwater cutting operations, and 

pipeline removal operations and to 

protect mariners from hazards 

associated with the same. 

Under 5 U.S.C. 553(d)(3), the Coast 

Guard finds that good cause exists for 

making this rule effective less than 30 

days after publication in the Federal 

Register. Delaying the effective date of 

this rule would be impracticable and 

contrary to the public interest because 

immediate action is needed to mitigate 

the hazards presented to safety of life on 

the Delaware River by the presence of 

dredge equipment, dredging operations, 

dive operations, and pipeline removal 

operations. 


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