Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics, 40157-40159 [E7-14149]
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Federal Register / Vol. 72, No. 140 / Monday, July 23, 2007 / Notices
funds, positions, personnel, records,
equipment, supplies and other sources.
Dated: July 12, 2007.
Joe W. Ellis,
Assistant Secretary for Administration and
Management.
[FR Doc. 07–3547 Filed 7–20–07; 8:45 am]
BILLING CODE 4150–04–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
Notice is hereby given that
the Office of Research Integrity (ORI)
and the Assistant Secretary for Health
have taken final action in the following
case:
James David Lieber, University of
California at Los Angeles: Based on the
findings of an inquiry report by the
University of California at Los Angeles
(UCLA) and additional analysis and
information obtained by the Office of
Research Integrity (ORI) during its
oversight review, the U.S. Public Health
Service (PHS) found that James David
Lieber, Staff Research Associate, Semel
Institute for Neuroscience and Human
Behavior, Integrated Substance Abuse
Programs, UCLA, engaged in research
misconduct in research funded by
National Institute on Drug Abuse
(NIDA), National Institutes of Health
(NIH), grant R01 DA15390.
Mr. Lieber knowingly and
intentionally falsified and fabricated
multiple follow-up interviews, urine
samples, and urine sample records of
human subject study participants and
entered such false and fabricated data
into the study’s data base. A total of 914
follow-up interviews of opiate users
were planned to be completed as part of
a study of gender differences in a follow
up of opiate users in California. Mr.
Lieber was assigned to interview 53 of
the 132 subjects located for the followup study. Over a six-month period, Mr.
Lieber falsely claimed to have
conducted face-to-face interviews for
the study while subsequent contacts
with the subjects revealed that they had
not been interviewed for the study. A
review by the institution determined
that the respondent fabricated
interviews for 20 of the 53 interviews
assigned to him. In addition, he falsified
the urine specimens for those 20
subjects and caused the entry of false
information into the study tracking and
locating data base for 11 subjects.
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SUMMARY:
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Aggravating factors included the theft of
$5180 for incentive payments to
subjects and travel expenses.
ORI has implemented the following
administrative actions for a period of
three (3) years, beginning on July 2,
2007:
(1) Mr. Lieber is debarred from
eligibility for any contracting or
subcontracting with any agency of the
United States Government and from
eligibility or involvement in
nonprocurement programs of the United
States Government referred to as
‘‘covered transactions’’ as defined in
HHS’ implementation of OMB
Guidelines to Agencies on
Governmentwide Debarment and
Suspension at 2 CFR part 376, et seq.;
and
(2) Mr. Lieber is prohibited from
serving in any advisory capacity to PHS,
including but not limited to service on
any PHS advisory committee, board,
and/or peer review committee, or as a
consultant.
FOR FURTHER INFORMATION CONTACT:
Director, Division of Investigative
Oversight, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8800.
Chris B. Pascal,
Director, Office of Research Integrity.
[FR Doc. E7–14185 Filed 7–20–07; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Secondary
Review Panel for Translation
Research; Improving Public Health
Practice through Translation Research
(R18), Request for Application (RFA)
CD07–005
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting:
Time and Date: 1 p.m.–3 p.m., August 7,
2007 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters To Be Discussed: The meeting will
include the review, discussion, and
evaluation of programmatic relevance and
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40157
priority of grant applications received in
response to RFA CD07–005, ‘‘Improving
Public Health Practice through Translation
Research (R18).’’
FOR FURTHER INFORMATION CONTACT:
Juliana Cyril, PhD, Scientific Program
Administrator, Office of Extramural
Research, CDC, 1600 Clifton Road NE.,
Mailstop D72, Atlanta, GA 30333,
Telephone 404.639.4639.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both CDC
and the Agency for Toxic Substances
and Disease Registry.
Edward Schultz,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E7–14148 Filed 7–20–07; 8:45 am]
BILLING CODE 4163–18–P
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.
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: https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
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40158
Federal Register / Vol. 72, No. 140 / Monday, July 23, 2007 / Notices
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
https://www.fda.gov/cber/guidelines.htm
or https://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
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17:09 Jul 20, 2007
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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 § 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 (§ 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:
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• 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 (§ 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 (§ 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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Federal Register / Vol. 72, No. 140 / Monday, July 23, 2007 / Notices
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 § 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 §§ 606.121, 606.122, and
610.40 have been approved under OMB
Control No. 0910–0116; § 610.2 has been
approved under OMB Control No. 0910–
0206; §§ 600.12(e) and 600.80 have been
approved under OMB Control No. 0910–
0308; §§ 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;
§§ 803.20, 803.50, and 803.53 have been
approved under OMB Control No. 0910–
0437; and §§ 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
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17:09 Jul 20, 2007
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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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Joint Meeting of the Cardiovascular
and Renal Drugs Advisory Committee
and the Drug Safety and Risk
Management Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committees: Cardiovascular
and Renal Drugs Advisory Committee
and the Drug Safety and Risk
Management Advisory Committee.
General Function of the Committees:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on September 12, 2007, from 8 a.m.
to 5 p.m.
Location: Hilton Washington DC
North/Gaithersburg, The Ballrooms, 620
Perry Pkwy., Gaithersburg, MD, 301–
977–8900.
Contact Person: Mimi Phan, Center
for Drug Evaluation and Research (HFD–
21), Food and Drug Administration,
5600 Fishers Lane (for express delivery,
5630 Fishers Lane, rm. 1093), Rockville,
MD 20857, 301–827–7001, FAX: 301–
827–6776, e-mail:
Mimi.Phan@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code 3014512533
or 3014512535. Please call the
Information Line for up-to-date
information on this meeting. A notice in
the Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
agency’s Web site and call the
appropriate advisory committee hot
line/phone line to learn about possible
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40159
modifications before coming to the
meeting.
Agenda: The committee will discuss
clinical data for aprotinin injection
(TRASYLOL, Bayer Pharmaceuticals), a
product indicated for prophylactic use
to reduce perioperative blood loss and
the need for blood transfusion in
patients undergoing cardiopulmonary
bypass in the course of coronary artery
bypass graft surgery who are at
increased risk for blood loss and blood
transfusion. This discussion follows a
September 27, 2006, FDA Public Health
Advisory regarding a study of aprotinin
injection safety (https://www.fda.gov/
cder/drug/advisory/
aprotinin20060929.htm).
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm, click on the
year 2007 and scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before August 28, 2007.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those desiring to make
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before August 20, 2007. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by August 21, 2007.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
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]]>Agencies
[Federal Register Volume 72, Number 140 (Monday, July 23, 2007)]
[Notices]
[Pages 40157-40159]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-14149]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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 https://www.fda.gov/cber/guidelines.htm or
https://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
[[Page 40159]]
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]
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