1260 Federal Register / Vol. 83, No. 7 / Wednesday, January 10, 2018 / Notices 

The decision to impose this freeze is 

procedural in nature, and therefore is 

not subject to the notice and comment 

and effective date requirements of the 

Administrative Procedure Act, 5 U.S.C. 

553(b)(A), (d). Moreover, the Media 

Bureau finds that there is good cause for 

not delaying the effect of these 

procedures until 30 days after 

publication in the Federal Register. 

Such a delay would be impractical, 

unnecessary, and contrary to the public 

interest because it would undercut the 

purposes of the freeze. 

This action is taken by the Chief, 

Media Bureau pursuant to authority 

delegated by 47 CFR 0.283 of the 

Commission’s rules. 

Federal Communications Commission. 

Barbara Kreisman, 

Chief, Video Division, Media Bureau. 

[FR Doc. 2018–00286 Filed 1–9–18; 8:45 am] 

BILLING CODE 6712–01–P 

FEDERAL MARITIME COMMISSION 

Notice of Agreement Filed 

The Commission hereby gives notice 

of the filing of the following agreement 

under the Shipping Act of 1984. 

Interested parties may submit comments 

on the agreement to the Secretary, 

Federal Maritime Commission, 

Washington, DC 20573, within twelve 

days of the date this notice appears in 

the Federal Register. A copy of the 

agreement is available through the 

Commission’s website (www.fmc.gov) or 

by contacting the Office of Agreements 

at (202)-523–5793 or tradeanalysis@

fmc.gov. 

Agreement No.: 201200–001. 

Title: Houston Marine Terminal 

Operators/Freight Handlers Agreement. 

Parties: Ceres Gulf Inc.; Cooper/Ports 

America LLC; and SSA Gulf, Inc. 

Filing Party: Shareen Larmond; West 

Gulf Maritime Association; 1717 

Turning Basin Drive, Suite 200; 

Houston, Texas 77029. 

Synopsis: The amendment updates 

the membership of the Agreement and 

makes other administrative changes. 

By Order of the Federal Maritime 

Commission. 

Dated: January 5, 2018. 

Rachel E. Dickon, 

Assistant Secretary. 

[FR Doc. 2018–00289 Filed 1–9–18; 8:45 am] 

BILLING CODE 6731–AA–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[CDC–2013–0015; Docket Number NIOSH 

237–A] 

National Framework for Personal 

Protective Equipment Conformity 

Assessment—Infrastructure 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH) of the Centers for Disease 

Control and Prevention (CDC), 

Department of Health and Human 

Services (HHS). 

ACTION: Notice of availability. 

SUMMARY: NIOSH announces the 

availability of the following publication: 

National Framework for Personal 

Protective Equipment Conformity 

Assessment—Infrastructure. 

DATES: The technical report was 

published on November 17, 2017. 

ADDRESSES: This document may be 

obtained at the following link: https://

www.cdc.gov/niosh/docs/2018-102/ 

default.html. 

FOR FURTHER INFORMATION CONTACT: 

Maryann M. D’Alessandro, NIOSH, 

National Personal Protective 

Technology Laboratory, 626 Cochrans 

Mill Road, Building 20, Pittsburgh, PA 

15236, email address: bpj5@cdc.gov, 

(412) 386–6111 (not a toll free number). 

SUPPLEMENTARY INFORMATION: In May 

2011, NIOSH published a notice in the 

Federal Register [76 FR 28791] 

requesting comments on the 

recommendations issued by the Institute 

of Medicine in a report they 

electronically published in November 

2010, titled, ‘‘Certifying Personal 

Protective Technologies.’’ In August 

2013, NIOSH published a notice in the 

Federal Register [78 FR 49524] 

requesting comments on the draft 

NIOSH response to the Institute of 

Medicine recommendations, and 

announcing a public meeting which was 

held on September 17, 2013. In response 

to a request, NIOSH extended the public 

comment period to December 2, 2013. 

All comments received were reviewed 

and addressed where appropriate. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health, Centers for Disease Control 

and Prevention. 

[FR Doc. 2018–00252 Filed 1–9–18; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0085] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Guidance for Industry: Cooperative 

Manufacturing Arrangements for 

Licensed Biologics 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or Agency) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by February 9, 

2018. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0629. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Guidance for Industry: Cooperative 

Manufacturing Arrangements for 

Licensed Biologics 

OMB Control Number 0910–0629— 

Extension 

This information collection supports 

the Agency guidance document entitled, 

‘‘Guidance for Industry: Cooperative 

Manufacturing for Licensed Biologics’’ 

(available at: https://www.fda.gov/ 

downloads/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/General/ 

ucm069908.pdf). The guidance 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 7 / Wednesday, January 10, 2018 / Notices 1261 

document provides information 

concerning cooperative manufacturing 

arrangements applicable to biological 

products subject to licensure under 

section 351 of the Public Health Service 

Act (42 U.S.C. 262). The guidance 

addresses several types of 

manufacturing arrangements (i.e., short 

supply arrangements, divided 

manufacturing arrangements, shared 

manufacturing arrangements, and 

contract manufacturing arrangements) 

and describes certain reporting and 

recordkeeping responsibilities 

associated with these arrangements, 

including the following: (1) Notification 

of all important proposed changes to 

production and facilities; (2) 

notification of results of tests and 

investigations regarding or possibly 

impacting the product; (3) notification 

of products manufactured in a contract 

facility; and (4) standard operating 

procedures. 

1. Notification of All Important 

Proposed Changes to Production and 

Facilities 

Each licensed manufacturer in a 

divided manufacturing arrangement or 

shared manufacturing arrangement must 

notify the appropriate FDA Center 

regarding proposed changes in the 

manufacture, testing, or specifications of 

its product, in accordance with § 601.12 

(21 CFR 601.12). In the guidance, we 

recommend that each licensed 

manufacturer that proposes such a 

change should also inform other 

participating licensed manufacturer(s) 

of the proposed change. 

For contract manufacturing 

arrangements, we recommend that the 

contract manufacturer should share 

with the license manufacturer all 

important proposed changes to 

production and facilities (including 

introduction of new products or at 

inspection). The license holder is 

responsible for reporting these changes 

to FDA (§ 601.12). 

2. Notification of Results of Tests and 

Investigations Regarding or Possibly 

Impacting the Product 

In the guidance, we recommend the 

following for contract manufacturing 

arrangements: 

• The contract manufacturer should 

fully inform the license manufacturer of 

the results of all tests and investigations 

regarding or possibly having an impact 

on the product; and 

• The license manufacturer should 

obtain assurance from the contractor 

that any FDA list of inspectional 

observations will be shared with the 

license manufacturer to allow 

evaluation of its impact on the purity, 

potency, and safety of the license 

manufacturer’s product. 

3. Notification of Products 

Manufactured in a Contract Facility 

In the guidance, we recommend for 

contract manufacturing arrangements 

that a license manufacturer cross 

reference a contract manufacturing 

facility’s master files only in 

circumstances involving certain 

proprietary information of the contract 

manufacturer, such as a list of all 

products manufactured in a contract 

facility. In this situation, the license 

manufacturer should be kept informed 

of the types or categories of all products 

manufactured in the contract facility. 

4. Standard Operating Procedures 

In the guidance, we remind the 

license manufacturer that the license 

manufacturer assumes responsibility for 

compliance with the applicable product 

and establishment standards (21 CFR 

600.3(t)). Therefore, if the license 

manufacturer enters into an agreement 

with a contract manufacturing facility, 

the license manufacturer must ensure 

that the facility complies with the 

applicable standards. An agreement 

between a license manufacturer and a 

contract manufacturing facility normally 

includes procedures to regularly assess 

the contract manufacturing facility’s 

compliance. These procedures may 

include, but are not limited to, review 

of records and manufacturing deviations 

and defects, and periodic audits. 

For shared manufacturing 

arrangements, each manufacturer must 

submit a separate biologics license 

application describing the 

manufacturing facilities and operations 

applicable to the preparation of that 

manufacturer’s biological substance or 

product (§ 601.2(a)). In the guidance, we 

state that we expect the manufacturer 

that prepares, or is responsible for the 

preparation of, the product in final form 

for commercial distribution to assume 

primary responsibility for providing 

data demonstrating the safety, purity, 

and potency of the final product. We 

also state that we expect the licensed 

finished product manufacturer to be 

primarily responsible for any 

postapproval obligations, such as 

postmarketing clinical trials, additional 

product stability studies, complaint 

handling, recalls, postmarket reporting 

of the dissemination of advertising and 

promotional labeling materials as 

required under § 601.12(f)(4), and 

adverse experience reporting. We 

recommend that the final product 

manufacturer establish a procedure with 

the other participating manufacturer(s) 

to obtain information in these areas. 

Description of Respondents: 

Respondents to the information 

collection are participating licensed 

manufacturers, final product 

manufacturers, and contract 

manufacturers associated with 

cooperative manufacturing 

arrangements subject to the associated 

regulations discussed in the guidance. 

In the Federal Register of August 7, 

2017 (82 FR 36797), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. We received no comments. 

Burden Estimate: We believe that the 

information collection provisions in the 

guidance do not create a new burden for 

respondents. We believe the reporting 

and recordkeeping provisions are part of 

usual and customary business practices. 

Licensed manufacturers would have 

contractual agreements with 

participating licensed manufacturers, 

final product manufacturers, and 

contract manufacturers, as applicable 

for the type of cooperative 

manufacturing arrangement, to address 

all these information collection 

provisions. 

The guidance also refers to previously 

approved collections of information 

found in FDA regulations at parts 201, 

207, 211, 600, 601, 606, 607, 610, 660, 

801, 803, 807, 809, and 820 (21 CFR 

parts 201, 207, 211, 600, 601, 606, 607, 

610, 660, 801, 803, 807, 809, and 820). 

The collections of information in parts 

606 and 610 have been approved under 

OMB control numbers 0910–0116, 

0910–0458, and 0910–0206; part 600 

has been approved under OMB control 

numbers 0910–0308 and 0910–0458; 

parts 601 and 660 have been approved 

under OMB control number 0910–0338; 

part 803 has been approved under OMB 

control number 0910–0437; part 211 has 

been approved under OMB control 

number 0910–0139; part 820 has been 

approved under OMB control number 

0910–0073; parts 207, 607, and 807 have 

been approved under OMB control 

numbers 0910–0045, 0910–0052, and 

0910–0625; and parts 201, 801, and 809 

have been approved under OMB control 

numbers 0910–0537, 0910–0572, and 

0910–0485. 

Dated: January 4, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00238 Filed 1–9–18; 8:45 am] 

BILLING CODE 4164–01–P 


daltland on DSKBBV9HB2PROD with NOTICES