Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics, 75569-75570 [2014-29611]
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Federal Register / Vol. 79, No. 243 / Thursday, December 18, 2014 / Notices
Federal Register notice must use the
appropriate FDA-supported standards,
formats, and terminologies specified in
the Data Standards Catalog for NDA,
ANDA, and certain BLA submissions.
Study data contained in certain IND
submissions must use the specified
formats for electronic submission in
studies with a start date 36 months or
later after this Federal Register notice of
availability.
In section 745A(a) of the FD&C Act,
Congress granted explicit authorization
to FDA to implement the statutory
electronic submission requirements by
specifying the format for such
submissions in guidance. Because this
guidance provides such requirements
under section 745A(a) of the FD&C Act,
indicated by the use of the words must
or required, it is not subject to the usual
restrictions in FDA’s good guidance
practice regulations, such as the
requirement that guidances not establish
legally enforceable responsibilities. See
21 CFR 10.115(d).
mstockstill on DSK4VPTVN1PROD with NOTICES
II. Paperwork Reduction Act of 1995
The guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The guidance
pertains to sponsors and applicants
making regulatory submissions to FDA
in electronic format for NDAs, ANDAs,
BLAs, and INDs. The information
collection discussed in the guidance is
contained in our IND regulations (21
CFR part 312) and approved under OMB
control number 0910–0014, our NDA
regulations (including ANDAs) (21 CFR
part 314) and approved under OMB
control number 0910–0001, and our
BLA regulations (21 CFR part 601) and
approved under OMB control number
0910–0338.
Sponsors and applicants have been
voluntarily submitting standardized
study data in electronic format. Under
FDASIA, sponsors and applicants will
be required to make all of these
submissions electronically in
compliance with the specified
standards, formats, and terminologies.
These requirements will be phased in
over 2- and 3-year periods after the
issuance of this guidance.
For many years sponsors and
applicants have been submitting
electronically using the electronic
common technical document format and
have included electronic study data in
approved (signed) by the Study Director. For
example, see Study Start Date in the SEND Trial
Summary Domain (TSPARMCD = STSTDTC),
https://www.cdisc.org.
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19:23 Dec 17, 2014
Jkt 235001
both legacy and standardized formats.
For some sponsors and applicants there
may be new costs, including capital
costs or operating and maintenance
costs, which would result from the
requirements under FDASIA and this
guidance, because some sponsors and
applicants would have to change from
submissions that have included legacy
(non-standard) study data to
submissions in compliance with this
guidance. FDA estimates that for some
sponsors and applicants the costs may
be as follows:
• Data management (hardware/
software): $350,000–$1,000,000
• Initial data management operations:
$500,000–$1,000,000
• Training: $100,000—$250,000
ACTION:
75569
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.
SUMMARY:
Fax written comments on the
collection of information by January 20,
2015.
DATES:
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 emailed 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.
ADDRESSES:
III. Comments
Interested persons may submit either
electronic comments to https://
www.regulations.gov or written
comments regarding this document to
the Division of Dockets Management
(see ADDRESSES). It is only necessary to
send one set of comments. Identify
comments with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday, and will be
posted to the docket at https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://www.fda.
gov/BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, or https://
www.regulations.gov.
Guidance for Industry: Cooperative
Manufacturing Arrangements for
Licensed Biologics—(OMB Control
Number 0910–0629)—Extension
Dated: December 12, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–29608 Filed 12–17–14; 8:45 am]
BILLING CODE 4164–01–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; Guidance for
Industry: Cooperative Manufacturing
Arrangements for Licensed Biologics
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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:
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.
E:\FR\FM\18DEN1.SGM
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75570
Federal Register / Vol. 79, No. 243 / Thursday, December 18, 2014 / Notices
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).
mstockstill on DSK4VPTVN1PROD with NOTICES
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
VerDate Sep<11>2014
19:23 Dec 17, 2014
Jkt 235001
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)). 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 § 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.
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
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, 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
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.
In the Federal Register of July 7, 2014
(79 FR 38318), FDA published a 60-day
notice requesting public comment on
the proposed collection of information.
We received no comments.
Dated: December 11, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–29611 Filed 12–17–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–1953]
Guidance for Industry on Providing
Regulatory Submissions in Electronic
Format—Submissions Under Section
745A(a) of the Federal Food, Drug, and
Cosmetic Act; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
SUMMARY:
E:\FR\FM\18DEN1.SGM
18DEN1
]]>Agencies
[Federal Register Volume 79, Number 243 (Thursday, December 18, 2014)]
[Notices]
[Pages 75569-75570]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29611]
-----------------------------------------------------------------------
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; 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 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 January
20, 2015.
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 emailed 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: 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: 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.
[[Page 75570]]
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 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 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, 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.
In the Federal Register of July 7, 2014 (79 FR 38318), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received no comments.
Dated: December 11, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29611 Filed 12-17-14; 8:45 am]
BILLING CODE 4164-01-P
