Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics, 36797-36799 [2017-16564]
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Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices
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Agenda: On September 13, 2017, the
VRBPAC will meet in an open session
to discuss and make recommendations
on the safety and effectiveness of Zoster
Vaccine Recombinant, Adjuvanted,
manufactured by GlaxoSmithKline
Biologicals. FDA intends to make
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public no later than 2 business days
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ADDRESSES:
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Dated: August 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–16519 Filed 8–4–17; 8:45 am]
BILLING CODE 4164–01–P
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36797
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.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (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 October 6, 2017.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before October 6,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of October 6, 2017. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
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Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices
mstockstill on DSK30JT082PROD with NOTICES
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2011–N–0085 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Guidance
for Industry: Cooperative Manufacturing
Arrangements for Licensed Biologics.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
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18:14 Aug 04, 2017
Jkt 241001
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–3850, 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
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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
This information collection supports
the Agency guidance document entitled,
‘‘Guidance for Industry: Cooperative
Manufacturing for Licensed Biologics.’’
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 (21 CFR 601.12).
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Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / 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.
mstockstill on DSK30JT082PROD with NOTICES
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 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
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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:
Respondents to the information
collection are participating licensed
manufacturers, final product
manufacturers, and contract
manufacturers associated with
cooperative manufacturing
arrangements subject to the associated
regulations discussed in the guidance.
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 parts
606 and 610 have been approved under
OMB control numbers 0910–0116,
0910–0458, and 0910–0206; part 600
has been approved under OMB control
numbers 0910–0308 and 0910–0458;
parts 601 and 660 have been approved
under OMB control number 0910–0338;
part 803 has been approved under OMB
control number 0910–0437; part 211 has
been approved under OMB control
number 0910–0139; part 820 has been
approved under OMB control number
0910–0073; parts 207, 607, and 807 have
been approved under OMB control
numbers 0910–0045, 0910–0052, and
0910–0625; and parts 201, 801, and 809
have been approved under OMB control
numbers 0910–0537, 0910–0572, and
0910–0485.
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36799
Dated: August 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–16564 Filed 8–4–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0110]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Prescription Drug
Advertisements
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
6, 2017.
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 0910–0686. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, 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.
SUMMARY:
Prescription Drug Advertisements (OMB
Control Number 0910–0686—Extension)
This information collection supports
Agency regulations. Section 502(n) of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 352(n))
requires that manufacturers, packers,
and distributors (sponsors) who
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Agencies
[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)]
[Notices]
[Pages 36797-36799]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16564]
-----------------------------------------------------------------------
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, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (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 October 6, 2017.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before October 6, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of October 6, 2017. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted,
[[Page 36798]]
such as medical information, your or anyone else's Social Security
number, or confidential business information, such as a manufacturing
process. Please note that if you include your name, contact
information, or other information that identifies you in the body of
your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2011-N-0085 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Guidance for Industry:
Cooperative Manufacturing Arrangements for Licensed Biologics.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-3850,
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
This information collection supports the Agency guidance document
entitled, ``Guidance for Industry: Cooperative Manufacturing for
Licensed Biologics.'' 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 (21 CFR 601.12).
[[Page 36799]]
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 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: Respondents to the information
collection are participating licensed manufacturers, final product
manufacturers, and contract manufacturers associated with cooperative
manufacturing arrangements subject to the associated regulations
discussed in the guidance.
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 parts 606 and 610 have been approved
under OMB control numbers 0910-0116, 0910-0458, and 0910-0206; part 600
has been approved under OMB control numbers 0910-0308 and 0910-0458;
parts 601 and 660 have been approved under OMB control number 0910-
0338; part 803 has been approved under OMB control number 0910-0437;
part 211 has been approved under OMB control number 0910-0139; part 820
has been approved under OMB control number 0910-0073; parts 207, 607,
and 807 have been approved under OMB control numbers 0910-0045, 0910-
0052, and 0910-0625; and parts 201, 801, and 809 have been approved
under OMB control numbers 0910-0537, 0910-0572, and 0910-0485.
Dated: August 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16564 Filed 8-4-17; 8:45 am]
BILLING CODE 4164-01-P