Document ID: FDA-2011-N-0085-0006
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics
Posted Date: 2017-08-07T04:00Z

[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)]
[Notices]
[Pages 36797-36799]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16564]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0085]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; 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, Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the proposed extension of the 
collection of information concerning cooperative manufacturing 
arrangements for licensed biologics.

DATES: Submit either electronic or written comments on the collection 
of information by October 6, 2017.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before October 6, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of October 6, 2017. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

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,

[[Page 36798]]

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-2011-N-0085 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Guidance for Industry: 
Cooperative Manufacturing Arrangements for Licensed Biologics.'' 
Received comments, those filed in a timely manner (see ADDRESSES), 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.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-3850, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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.'' The guidance 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 (21 CFR 601.12).

[[Page 36799]]

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.
    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: August 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16564 Filed 8-4-17; 8:45 am]
 BILLING CODE 4164-01-P