0629 GFI Coop MFR Arrangements SSA 2018 ext

U.S. Food and Drug Administration
Guidance for Industry (GFI); Cooperative Manufacturing
Arrangements for Licensed Biologics
OMB Control No. 0910-0629
SUPPORTING STATEMENT Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA) guidance entitled
“Guidance for Industry; Cooperative Manufacturing Arrangements for Licensed Biologics.”
The guidance document provides information concerning the various cooperative manufacturing
arrangements used in the production of biological products subject to licensure under section 351
of the PHS Act (42 U.S.C. 262). It describes FDA's current thinking on licensing strategies for
meeting the increased need for planning flexible manufacturing arrangements. Because
cooperative manufacturing arrangements can take a considerable amount of time to develop, the
guidance may be useful for planning purposes in the early phases of product development.
Several types of manufacturing arrangements discussed in the guidance include short supply
arrangements, divided manufacturing arrangements, shared manufacturing arrangements, and
contract manufacturing arrangements. These recommendations contain certain information
collection suggestions including:
Activity

Description

Reporting: Notification of all
important proposed changes to
production and facilities

Recommends (for a divided manufacturing arrangement or shared
manufacturing arrangement) that each licensed manufacturer that
proposes such a change should inform the other participating
licensed manufacturer(s) of the proposed change.
Recommends (for contract manufacturing arrangements) 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).

Reporting: Notification of results
of tests and investigations
regarding or possibly impacting
the product

Recommends (for contract manufacturing arrangements) that 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.
Recommends (for contract manufacturing arrangements) that 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.

Activity

Description

Reporting: Notification of
products manufactured in a
contract facility

Recommends (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.

Recordkeeping: Standard
Operating Procedures

Reminds (for contract manufacturing arrangements) the license
manufacturer that an agreement between a license manufacturer
and a contract manufacturing facility normally includes procedures
to regularly assess the contract manufacturing facility’s compliance
with the applicable product and establishment standards. These
procedures may include, but are not limited to review of records
and manufacturing deviations and defects, and periodic audits.
Recommends (for shared manufacturing arrangements) that the
final product manufacturer establish a procedure with the other
participating manufacturer(s) to obtain certain information relating
to the final product and post-approval 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 §21 CFR 601.12(f)(4) and adverse experience
reporting.

Although we believe these activities impose no burden on respondents beyond those considered
usual and customary business practice, we retain a nominal burden estimate and continue to
invite public comment on the information collection consistent with PRA regulations. Since
establishment of the collection we have received no comments to warrant revising this estimate
and therefore request extension of OMB approval.
2. Purpose and Use of the Information Collection
The development of complex and highly specialized technology and equipment for the manufacture
of biological products has fostered the emergence of many companies that perform only limited
aspects of manufacturing processes. Consequently, many manufacturers are interested in sharing or
contracting parts of manufacturing in order to facilitate product development and manufacturing
flexibility. Cooperative manufacturing arrangements enhance the development of new products.

3. Use of Improved Information Technology and Burden Reduction
Notifications can be accomplished by e-mail, fax, or mail. Respondents can use computers,
computer discs, tapes, microfiche, or microfilm, etc., in lieu of hard copy records for the purpose
of maintaining records. FDA is not aware of any other improved technology to reduce the
burden.

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4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. However, respondents should note the
guidance document discusses a broad range of topics and makes reference to several agency
regulations supported by individually established ICRs, including but not necessarily limited to
currently approved OMB Control Nos. 0910-0116; 0910-0139; 0910-0206; 0910-0308; 09100338; 0910-0437; 0910-0458; 0910-0045; 0910-0052; 0910-0073; 0910-0625; 0910-0537; 09100572; and 0910-0485.
5. Impact on Small Businesses or Other Small Entities
The information collection provided in the guidance applies to small as well as large facilities.
Although FDA must apply the statutory and regulatory requirements to all enterprises, FDA does
provide special help to small businesses. The Center for Biologics Evaluation and Research
(CBER), Office of Communication, Outreach, and Development, Division of Manufacturer’s
Assistance and Training, and the Center for Drug Evaluation and Research (CDER), Office of
Communication, Division of Drug Information provide assistance to small businesses subject to
FDA’s regulatory requirements.
6. Consequences of Collecting the Information Less Frequently
Information collection schedule is consistent with guidance recommendations.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8, FDA published a 60 day notice for public comment in the
Federal Register of August 7, 2017, (82 FR 36797). No public comments were received.
9. Explanation of Any Payment or Gift to Respondents
No payment or gift was provided to respondents.
10. Assurance of Confidentiality Provided to Respondents
The confidentiality of information received by FDA is consistent with the Freedom of
Information Act (FOIA) and the FDA’s published regulations under 21 CFR Part 20, 21 CFR
312.130, 314.430, 601.50, 601.51, 807.95, 809.4, 812.38, and 814.122.

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11. Justification for Sensitive Questions
Questions of a sensitive nature are not applicable to this information collection.
12. Estimates of Annualized Burden Hours and Costs
As previously discussed, FDA believes that the information collection provisions found in the
guidance document create no new burden for respondents. Rather, we believe the reporting and
recordkeeping provisions are part of usual and customary business practice associated with
licensed biological establishment practice. For example, we expect licensed manufacturers to
already have available information referenced in the guidance such as contractual agreements
with participating licensed manufacturers, final product manufacturers, and contract
manufacturers. Likewise, we expect respondents already retain listings of all product types
manufactured in a contract facility (e.g., contract filler for vaccines) that are part of a contractual
agreement. The contract facility provides this information to FDA in a Master File and the
licensed manufacturer provides a cross-reference to the Master File as part of its license
application. We therefore retain a nominal burden of one respondent and one burden hour;
however, FDA continues to invite public comment on the information collection consistent with
PRA requirements.
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers
There are no capital, start-up, operating or maintenance costs associated with this collection of
information.
14. Annualized Cost to the Federal Government
There is no estimated annual cost to the Federal Government associated with this collection of
information.
15. Explanation for Program Changes or Adjustments
We retain the currently approved burden estimate for the information collection.
16. Plans for Tabulation and Publication and Project Time Schedule
There are no tabulated results to publish for this information collection.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display of the OMB Expiration Date is appropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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