Agency Information Collection Activities; Submission for Office of Management and Budget Review; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics, 1260-1261 [2018-00238]
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Federal Register / Vol. 83, No. 7 / Wednesday, January 10, 2018 / Notices
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Food and Drug Administration
[CDC–2013–0015; Docket Number NIOSH
237–A]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Guidance for Industry: Cooperative
Manufacturing Arrangements for
Licensed Biologics
Federal Communications Commission.
Barbara Kreisman,
Chief, Video Division, Media Bureau.
ACTION:
National Framework for Personal
Protective Equipment Conformity
Assessment—Infrastructure
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
AGENCY:
Notice of availability.
NIOSH announces the
availability of the following publication:
National Framework for Personal
Protective Equipment Conformity
Assessment—Infrastructure.
SUMMARY:
[FR Doc. 2018–00286 Filed 1–9–18; 8:45 am]
BILLING CODE 6712–01–P
The technical report was
published on November 17, 2017.
DATES:
FEDERAL MARITIME COMMISSION
The Commission hereby gives notice
of the filing of the following agreement
under the Shipping Act of 1984.
Interested parties may submit comments
on the agreement to the Secretary,
Federal Maritime Commission,
Washington, DC 20573, within twelve
days of the date this notice appears in
the Federal Register. A copy of the
agreement is available through the
Commission’s website (www.fmc.gov) or
by contacting the Office of Agreements
at (202)-523–5793 or tradeanalysis@
fmc.gov.
Agreement No.: 201200–001.
Title: Houston Marine Terminal
Operators/Freight Handlers Agreement.
Parties: Ceres Gulf Inc.; Cooper/Ports
America LLC; and SSA Gulf, Inc.
Filing Party: Shareen Larmond; West
Gulf Maritime Association; 1717
Turning Basin Drive, Suite 200;
Houston, Texas 77029.
Synopsis: The amendment updates
the membership of the Agreement and
makes other administrative changes.
daltland on DSKBBV9HB2PROD with NOTICES
This document may be
obtained at the following link: https://
www.cdc.gov/niosh/docs/2018-102/
default.html.
ADDRESSES:
Notice of Agreement Filed
FOR FURTHER INFORMATION CONTACT:
Maryann M. D’Alessandro, NIOSH,
National Personal Protective
Technology Laboratory, 626 Cochrans
Mill Road, Building 20, Pittsburgh, PA
15236, email address: bpj5@cdc.gov,
(412) 386–6111 (not a toll free number).
In May
2011, NIOSH published a notice in the
Federal Register [76 FR 28791]
requesting comments on the
recommendations issued by the Institute
of Medicine in a report they
electronically published in November
2010, titled, ‘‘Certifying Personal
Protective Technologies.’’ In August
2013, NIOSH published a notice in the
Federal Register [78 FR 49524]
requesting comments on the draft
NIOSH response to the Institute of
Medicine recommendations, and
announcing a public meeting which was
held on September 17, 2013. In response
to a request, NIOSH extended the public
comment period to December 2, 2013.
All comments received were reviewed
and addressed where appropriate.
SUPPLEMENTARY INFORMATION:
By Order of the Federal Maritime
Commission.
Dated: January 5, 2018.
Rachel E. Dickon,
Assistant Secretary.
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2018–00289 Filed 1–9–18; 8:45 am]
[FR Doc. 2018–00252 Filed 1–9–18; 8:45 am]
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[Docket No. FDA–2011–N–0085]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, we, or Agency) 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 February 9,
2018.
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.
SUMMARY:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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
This information collection supports
the Agency guidance document entitled,
‘‘Guidance for Industry: Cooperative
Manufacturing for Licensed Biologics’’
(available at: https://www.fda.gov/
downloads/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/General/
ucm069908.pdf). The guidance
E:\FR\FM\10JAN1.SGM
10JAN1
Federal Register / Vol. 83, No. 7 / Wednesday, January 10, 2018 / Notices
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).
daltland on DSKBBV9HB2PROD 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
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18:23 Jan 09, 2018
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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 (§ 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
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1261
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.
In the Federal Register of August 7,
2017 (82 FR 36797), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. We received no comments.
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: January 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–00238 Filed 1–9–18; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 83, Number 7 (Wednesday, January 10, 2018)]
[Notices]
[Pages 1260-1261]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00238]
-----------------------------------------------------------------------
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; Guidance for Industry: Cooperative
Manufacturing Arrangements for Licensed Biologics
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, we, or Agency) 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
February 9, 2018.
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 [email protected]. 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: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
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
This information collection supports the Agency guidance document
entitled, ``Guidance for Industry: Cooperative Manufacturing for
Licensed Biologics'' (available at: https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/General/ucm069908.pdf). The guidance
[[Page 1261]]
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 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.
In the Federal Register of August 7, 2017 (82 FR 36797), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received no comments.
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: January 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00238 Filed 1-9-18; 8:45 am]
BILLING CODE 4164-01-P
