[Federal Register Volume 72, Number 222 (Monday, November 19, 2007)]
[Notices]
[Pages 65034-65036]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22489]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1999D-2013]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Draft Guidance for 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 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.

[[Page 65035]]


DATES: Fax written comments on the collection of information by 
December 19, 2007.

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: 202-395-6974, or e-mailed to [email protected]. All comments 
should be identified with the OMB control number 0910-NEW and title 
``Draft Guidance for Industry: Cooperative Manufacturing Arrangements 
for Licensed Biologics.'' Also include the FDA docket number found in 
brackets in the heading of this document.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Draft Guidance for Industry: Cooperative Manufacturing Arrangements for 
Licensed Biologics--(OMB Control Number 0910-NEW)

    The draft guidance document, when finalized, will provide 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 The draft guidance addresses 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 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,

[[Page 65036]]

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.
    In the Federal Register of July 23, 2007 (72 FR 40157), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received on the information 
collection.

    Dated: November 13, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-22489 Filed 11-16-07; 8:45 am]
BILLING CODE 4160-01-S