Document ID: FDA-2011-N-0085-0007
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Guidance for Industry: Cooperative
Manufacturing Arrangements for Licensed Biologics
Posted Date: 2018-01-10T05:00Z

[Federal Register Volume 83, Number 7 (Wednesday, January 10, 2018)]
[Notices]
[Pages 1260-1261]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00238]

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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.

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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 [email protected]. 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, 
[email protected].

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/GuidanceComplianceRegulatoryInformation/Guidances/General/ucm069908.pdf). The guidance

[[Page 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 Sec.  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 (Sec.  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 (Sec.  
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 Sec.  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