[Federal Register: July 23, 2007 (Volume 72, Number 140)]
[Notices]
[Page 40157-40159]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jy07-57]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 1999D-2013 (formerly Docket No. 99D-2013)]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Draft Guidance for Industry: Cooperative Manufacturing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) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the proposed collection of information
concerning cooperative manufacturing arrangements for licensed
biologics.
DATES: Submit written or electronic comments on the collection of
information by September 21, 2007.
ADDRESSES: Submit electronic comments on the collection of information
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on
the collection of information to the Division of Dockets Management
(HFA-305), Food and Drug
[[Page 40158]]
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All
comments should be identified with the docket number found in brackets
in the heading of this document.
Submit written requests for single copies of the draft guidance
dated January 2007 to the Office of Communication, Training, and
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and
Research (CBER), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive
label to assist the office in processing your requests. The draft
guidance may also be obtained by mail by calling CBER at 1-800-835-4709
or 301-827-1800. Persons with access to the Internet may obtain the
draft guidance at either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm or
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
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 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.
Draft Guidance for Industry: Cooperative Manufacturing Arrangements for
Licensed Biologics
The draft guidance document, when finalized, will provide
information concerning cooperative manufacturing arrangements
applicable to biological products subject to licensure under section
351 of the U.S. Public Health Service Act. The draft 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, for the licensed manufacturer(s), contract
manufacturer(s), and final product manufacturer(s) including the
following: (1) Notification of any proposed change in the product,
production process, quality controls or facilities; (2) notification of
results of tests and investigations related to or impacting the
product; (3) notification of products manufactured in a contract
facility; and (4) standard operating procedures.
A. Notification of Any Proposed Change in the Product, Production
Process, Quality Controls or Facility
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 draft guidance, we recommend that each licensed
manufacturer that proposes such a change should 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).
B. Notification of Results of Tests and Investigations Related to or
Impacting the Product
In the draft 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.
C. Notification of Products Manufactured in a Contract Facility
In the draft 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.
D. Standard Operating Procedures
In the draft guidance, we remind the license manufacture that the
license manufacturer assumes responsibility for compliance with the
applicable product and establishment standards (Sec. 600.3(t)) (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))
(21 CFR 601.2(a)). In this draft guidance, 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 expect the licensed finished product
manufacturer to be primarily
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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: The recordkeeping and reporting
recommendations described in this document affect the participating
licensed manufacturer(s), final product manufacturer(s), and contract
manufacturer(s) associated with cooperative manufacturing arrangements.
Burden Estimate: We believe that the information collection
provisions in the draft guidance do not create a new burden for
respondents. We believe the reporting and recordkeeping provisions are
part of usual and customary business practice. 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.
This draft guidance also refers to previously approved collections
of information found in FDA regulations at parts 201, 207, 211, 600,
601, 606, 607, 610, 660, 803, and 807 (21 CFR parts 201, 207, 211, 600,
601, 606, 607, 610, 660, 803, and 807). The collections of information
in Sec. Sec. 606.121, 606.122, and 610.40 have been approved under OMB
Control No. 0910-0116; Sec. 610.2 has been approved under OMB Control
No. 0910-0206; Sec. Sec. 600.12(e) and 600.80 have been approved under
OMB Control No. 0910-0308; Sec. Sec. 601.2(a), 601.12, 610.60, 610.61,
610.62, 610.67, 660.2(c), 660.28(a) and (b), 660.35(a), (c) through
(g), and (i) through (m), 660.45, and 660.55(a) and (b) have been
approved under OMB Control No. 0910-0338; Sec. Sec. 803.20, 803.50,
and 803.53 have been approved under OMB Control No. 0910-0437; and
Sec. Sec. 600.14 and 606.171 have been approved under OMB Control No.
0910-0458. The current good manufacturing practice regulations for
finished pharmaceuticals (part 211) have been approved under OMB
Control No. 0910-0139; the establishment registration regulations
(parts 207, 607, and 807) have been approved under OMB Control Nos.
0910-0045, 0910-0052, and 0910-0387; and the labeling regulations (part
201) have been approved under OMB Control Nos. 0910-0340 and 0910-0370.
Dated: July 17, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-14149 Filed 7-20-07; 8:45 am]
BILLING CODE 4160-01-S