Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics, 38318-38319 [2014-15810]
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Federal Register / Vol. 79, No. 129 / Monday, July 7, 2014 / Notices
increase in the annual time burden
resulted from increases in the amount of
time necessary to research and prepares
the certification from .01 hours (less
than one minute) to .25 hours (15
minutes). No public comments were
received in prior years that have
challenged the validity of the
Government’s estimate.
Respondents: 13,486.
Responses per Respondent: 76.
Total Responses: 1,024,936.
Hours per Response: .25.
Total Burden hours: 256,234.
C. Public Comments
Public comments are particularly
invited on: Whether this collection of
information is necessary for the proper
performance of functions of the FAR,
and whether it will have practical
utility; whether our estimate of the
public burden of this collection of
information is accurate, and based on
valid assumptions and methodology;
ways to enhance the quality, utility, and
clarity of the information to be
collected; and ways in which we can
minimize the burden of the collection of
information on those who are to
respond, through the use of appropriate
technological collection techniques or
other forms of information technology.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat Division (MVCB),
1800 F Street NW., Washington, DC
20405. ATTN: Ms. Flowers/IC 9000–
0018, telephone 202–501–4755.
Please cite OMB Control No. 9000–
0018, Certification of Independent Price
Determination and Parent Company and
Identifying Data, in all correspondence.
Dated: June 27, 2014.
Karlos Morgan,
Acting Director, Federal Acquisition Policy
Division, Office of Government-wide
Acquisition Policy, Office of Acquisition
Policy, Office of Government-wide Policy.
[FR Doc. 2014–15639 Filed 7–3–14; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
[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.
VerDate Mar<15>2010
15:59 Jul 03, 2014
Jkt 232001
ACTION:
Notice.
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, 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 September 5, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
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.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, 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
SUMMARY:
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Sfmt 4703
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
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 § 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
E:\FR\FM\07JYN1.SGM
07JYN1
Federal Register / Vol. 79, No. 129 / Monday, July 7, 2014 / Notices
introduction of new products or at
inspection). The license holder is
responsible for reporting these changes
to FDA (§ 601.12).
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.
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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 manufacture 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 (BLA) describing the
manufacturing facilities and operations
applicable to the preparation of that
manufacturer’s biological substance or
product (§ 601.2(a)). In the guidance, we
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15:59 Jul 03, 2014
Jkt 232001
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 § 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
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, and 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
§§ 606.121, 606.122, and 610.40 have
been approved under OMB control
number 0910–0116; § 610.2 has been
approved under OMB control number
0910–0206; §§ 600.12(e) and 600.80
have been approved under OMB control
number 0910–0308; §§ 601.2(a), 601.12,
610.60 through 610.65, 610.67, 660.2(c),
660.28(a) and (b), 660.35(a), (c) through
(g), (i) through (m), 660.45, and
660.55(a) and (b) have been approved
under OMB control number 0910–0338;
§§ 803.20, 803.50, and 803.53 have been
approved under OMB control number
0910–0437; and §§ 600.14 and 606.171
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38319
have been approved under OMB control
number 0910–0458. The current good
manufacturing practice regulations for
finished pharmaceuticals (part 211)
have been approved under OMB control
number 0910–0139; §§ 820.181 and
820.184 have been approved under
OMB control number 0910–0073; the
establishment registration regulations
(parts 207, 607, and 807) have been
approved under OMB control numbers
0910–0045, 0910–0052, and 0910–0625;
and the labeling regulations (parts 201,
801, and 809) have been approved
under OMB control numbers 0910–
0537, 0910–0572, and 0910–0485.
Dated: July 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–15810 Filed 7–3–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0587]
Guidance for Industry on Neglected
Tropical Diseases of the Developing
World: Developing Drugs for
Treatment or Prevention; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Neglected Tropical Diseases of
the Developing World: Developing
Drugs for Treatment or Prevention.’’ The
purpose of the guidance is to assist
sponsors in the development of drugs
for the treatment or prevention of
neglected tropical diseases (NTDs). This
guidance represents the FDA’s current
thinking regarding drug development
for the treatment or prevention of NTDs,
including clinical trial designs and
internal review standards to support
approval of drugs. This guidance
finalizes the draft guidance issued
August 24, 2011.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
SUMMARY:
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]]>Agencies
[Federal Register Volume 79, Number 129 (Monday, July 7, 2014)]
[Notices]
[Pages 38318-38319]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15810]
=======================================================================
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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.
-----------------------------------------------------------------------
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,
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 September 5, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug 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.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, 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
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
[[Page 38319]]
introduction of new products or at inspection). The license holder is
responsible for reporting these changes to FDA (Sec. 601.12).
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 manufacture 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 (BLA) 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: 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 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, and 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 Sec. Sec. 606.121, 606.122, and
610.40 have been approved under OMB control number 0910-0116; Sec.
610.2 has been approved under OMB control number 0910-0206; Sec. Sec.
600.12(e) and 600.80 have been approved under OMB control number 0910-
0308; Sec. Sec. 601.2(a), 601.12, 610.60 through 610.65, 610.67,
660.2(c), 660.28(a) and (b), 660.35(a), (c) through (g), (i) through
(m), 660.45, and 660.55(a) and (b) have been approved under OMB control
number 0910-0338; Sec. Sec. 803.20, 803.50, and 803.53 have been
approved under OMB control number 0910-0437; and Sec. Sec. 600.14 and
606.171 have been approved under OMB control number 0910-0458. The
current good manufacturing practice regulations for finished
pharmaceuticals (part 211) have been approved under OMB control number
0910-0139; Sec. Sec. 820.181 and 820.184 have been approved under OMB
control number 0910-0073; the establishment registration regulations
(parts 207, 607, and 807) have been approved under OMB control numbers
0910-0045, 0910-0052, and 0910-0625; and the labeling regulations
(parts 201, 801, and 809) have been approved under OMB control numbers
0910-0537, 0910-0572, and 0910-0485.
Dated: July 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15810 Filed 7-3-14; 8:45 am]
BILLING CODE 4164-01-P
