Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Cooperative Manufacturing Arrangements for Licensed Biologics, 48166-48167 [2011-19958]
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48166
Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Notices
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
E-mail: OIRA_SUBMISSION@OMB.eop.
gov, Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–19974 Filed 8–5–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0085]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Cooperative
Manufacturing Arrangements for
Licensed Biologics
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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.
DATES: Fax written comments on the
collection of information by September
7, 2011.
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–
395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0629. Also
include the FDA docket number found
in brackets in the heading of this
document.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–7651,
juanmanuel.vilela@fda.hhs.gov.
VerDate Mar<15>2010
18:57 Aug 05, 2011
Jkt 223001
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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
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:
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
• 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 (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
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
E:\FR\FM\08AUN1.SGM
08AUN1
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Notices
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), and (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
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
VerDate Mar<15>2010
18:57 Aug 05, 2011
Jkt 223001
0910–0045, 0910–0052, and 0910–0387;
and the labeling regulations (parts 201,
801, and 809) have been approved
under OMB control numbers 0910–
0537, 0910–0572, and 0910–0485.
In the Federal Register of March 16,
2011 (76 FR 14405), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received from the public.
Dated: August 2, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2011–19958 Filed 8–5–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0508]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Blood
Establishment Registration and
Product Listing, Form FDA 2830
AGENCY:
Food and Drug Administration,
HHS.
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 information collection requirements
relating to the blood establishment
registration and product listing
requirements in the Agency’s
regulations and Form FDA 2830.
DATES: Submit either electronic or
written comments on the collection of
information by October 7, 2011.
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
SUMMARY:
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
48167
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–7651.
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.
Blood Establishment Registration and
Product Listing, Form FDA 2830—21
CFR Part 607—(OMB Control Number
0910–0052)—Extension
Under section 510 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
360), any person owning or operating an
establishment that manufactures,
prepares, propagates, compounds, or
processes a drug or device must register
with the Secretary of Health and Human
Services, on or before December 31 of
each year, his or her name, place of
business, and all such establishments,
and must submit, among other
E:\FR\FM\08AUN1.SGM
08AUN1
]]>Agencies
[Federal Register Volume 76, Number 152 (Monday, August 8, 2011)]
[Notices]
[Pages 48166-48167]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19958]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0085]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Cooperative
Manufacturing Arrangements for Licensed Biologics
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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.
DATES: Fax written comments on the collection of information by
September 7, 2011.
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: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0629.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-7651,
juanmanuel.vilela@fda.hhs.gov.
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.
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
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 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 (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 post-approval
obligations, such as
[[Page 48167]]
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), and (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 0910-0387; and the labeling regulations
(parts 201, 801, and 809) have been approved under OMB control numbers
0910-0537, 0910-0572, and 0910-0485.
In the Federal Register of March 16, 2011 (76 FR 14405), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received from the public.
Dated: August 2, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2011-19958 Filed 8-5-11; 8:45 am]
BILLING CODE 4160-01-P
