M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk; International Conference on Harmonisation; Guidance for Industry; Availability, 30465-30466 [2015-12752]
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30465
Federal Register / Vol. 80, No. 102 / Thursday, May 28, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondents
Number of
respondents
Form name
Form 6—Therapy Attitude Inventory and
System Usability Scale—Attachment I6.
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science,Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2015–12809 Filed 5–27–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Head Start Facilities
Construction, Purchase and Major
Renovation.
OMB No.: 0970–0193.
Description: The Office of Head Start
within the Administration for Children
and Families, United States Department
of Health and Human Services, is
proposing to renew authority to collect
information on funding for the
purchase, construction or renovation of
facilities. All information is collected
electronically through the Head Start
Enterprise System (HSES). The
information required is in conformance
with Section 644(f) and (g) of the Act.
Federal funding officials use the
information to determine that the
proposed purchase has resulted in
savings when compared to the costs that
would be incurred to acquire the use of
an alternative facility, or that the lack of
alternative facilities will prevent, or
would have prevented, the operation of
the program. The rule further describes
Average
burden per
response
(in hours)
Number of
responses per
respondent
200
1
15/60
the assurances which are necessary to
protect the Federal interest in real
property and the conditions under
which federal interest may be
subordinated and protected when
grantees make use of debt instruments
when purchasing facilities. The
information is used by funding officials
to determine if grantee’s arrangements
adequately conform to other applicable
statutes which apply to the expenditure
of public funds for the purchase of real
property.
Respondents: Head Start and Early
Head Start program grant recipients.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Administrative Requirements ...........................................................................
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Instruments
225
1
41
9225
Estimated Total Annual Burden
Hours: 9225.
Cost per respondent is $40 estimated
at 2 hours × $20.00 per hour.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade, SW., Washington, DC
20447, Attn: ACF Reports Clearance
Officer. Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
VerDate Sep<11>2014
20:06 May 27, 2015
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functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Robert Sargis,
Reports Clearance Officer.
SUMMARY:
[FR Doc. 2015–12924 Filed 5–27–15; 8:45 am]
BILLING CODE 4184–01–P
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Food and Drug Administration
[Docket No. FDA–2013–D–0369]
M7 Assessment and Control of DNA
Reactive (Mutagenic) Impurities in
Pharmaceuticals to Limit Potential
Carcinogenic Risk; International
Conference on Harmonisation;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance entitled ‘‘M7 Assessment and
Control of DNA Reactive (Mutagenic)
Impurities in Pharmaceuticals to Limit
Potential Carcinogenic Risk.’’ The
guidance was prepared under the
auspices of the International Conference
on Harmonisation of Technical
E:\FR\FM\28MYN1.SGM
28MYN1
30466
Federal Register / Vol. 80, No. 102 / Thursday, May 28, 2015 / Notices
Requirements for Registration of
Pharmaceuticals for Human Use (ICH).
The guidance emphasizes
considerations of both safety and quality
risk management in establishing levels
of mutagenic impurities that are
expected to pose negligible carcinogenic
risk. It outlines recommendations for
assessment and control of mutagenic
impurities that reside or are reasonably
expected to reside in a final drug
substance or product, taking into
consideration the intended conditions
of human use. The guidance is intended
to provide guidance for new drug
substances and new drug products
during their clinical development and
subsequent applications for marketing.
Submit either electronic or
written comments on Agency guidances
at any time.
DATES:
Submit written requests for
single copies of the guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research (CDER), Food and Drug
Administration, 10001 New Hampshire
Ave., Hillandale Building, 4th Floor,
Silver Spring, MD 20993; or the Office
of Communication, Outreach, and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–7800. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
ADDRESSES:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Aisar
Atrakchi, Center for Drug Evaluation
and Research, Food and Drug
Administration, Bldg. 22, Rm. 4118,
Silver Spring, MD 20993–0002, 301–
796–1036.
Regarding the ICH: Michelle Limoli,
Center for Drug Evaluation and
Research, International Programs, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1174,
Rockville, MD 20993–0002, 301–796–
8377.
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
18:18 May 27, 2015
Jkt 235001
I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
harmonization of regulatory
requirements. FDA has participated in
many meetings designed to enhance
harmonization and is committed to
seeking scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for drug development
among regulatory agencies.
ICH was organized to provide an
opportunity for tripartite harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. FDA also seeks input
from consumer representatives and
others. ICH is concerned with
harmonization of technical
requirements for the registration of
pharmaceutical products among three
regions: The European Union, Japan,
and the United States. The six ICH
sponsors are the European Commission;
the European Federation of
Pharmaceutical Industries Associations;
the Japanese Ministry of Health, Labour,
and Welfare; the Japanese
Pharmaceutical Manufacturers
Association; CDER and CBER, FDA; and
the Pharmaceutical Research and
Manufacturers of America. The ICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes
representatives from each of the ICH
sponsors and the IFPMA, as well as
observers from the World Health
Organization, Health Canada, and the
European Free Trade Area.
In the Federal Register of April 15,
2013 (72 FR 22269), FDA published a
notice announcing the availability of a
draft guidance entitled ‘‘M7 Assessment
and Control of DNA Reactive
(Mutagenic) Impurities in
Pharmaceuticals to Limit Potential
Carcinogenic Risk’’ The notice gave
interested persons an opportunity to
submit comments by June 14, 2013.
Changes made to the guidance took into
consideration written comments
received. Minor editorial changes were
made to improve clarity.
After consideration of the comments
received and revisions to the guidance,
a final draft of the guidance was
submitted to the ICH Steering
Committee and endorsed by the three
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
participating regulatory agencies in June
2014.
The guidance provides guidance on
the regulation of genotoxic impurities in
new drug substances and drug products.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on this topic. It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments 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.
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.regulations.gov, https://www.fda.
gov/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, or https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm.
Dated: May 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–12752 Filed 5–27–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–2065]
Radiation Biodosimetry Devices; Draft
Guidance for Industry and Food and
Drug Administration Staff; Extension
of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice; reopening of the
comment period.
ACTION:
The Food and Drug
Administration (FDA) is reopening the
comment period for an additional 30
days, for the notice of availability
SUMMARY:
E:\FR\FM\28MYN1.SGM
28MYN1
]]>Agencies
[Federal Register Volume 80, Number 102 (Thursday, May 28, 2015)]
[Notices]
[Pages 30465-30466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12752]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0369]
M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities
in Pharmaceuticals to Limit Potential Carcinogenic Risk; International
Conference on Harmonisation; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance entitled ``M7 Assessment and Control of
DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit
Potential Carcinogenic Risk.'' The guidance was prepared under the
auspices of the International Conference on Harmonisation of Technical
[[Page 30466]]
Requirements for Registration of Pharmaceuticals for Human Use (ICH).
The guidance emphasizes considerations of both safety and quality risk
management in establishing levels of mutagenic impurities that are
expected to pose negligible carcinogenic risk. It outlines
recommendations for assessment and control of mutagenic impurities that
reside or are reasonably expected to reside in a final drug substance
or product, taking into consideration the intended conditions of human
use. The guidance is intended to provide guidance for new drug
substances and new drug products during their clinical development and
subsequent applications for marketing.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Division of Drug Information (HFD-240), Center for Drug Evaluation
and Research (CDER), Food and Drug Administration, 10001 New Hampshire
Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993; or the
Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist the office in
processing your requests. The guidance may also be obtained by mail by
calling CBER at 1-800-835-4709 or 240-402-7800. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Aisar Atrakchi, Center for Drug Evaluation
and Research, Food and Drug Administration, Bldg. 22, Rm. 4118, Silver
Spring, MD 20993-0002, 301-796-1036.
Regarding the ICH: Michelle Limoli, Center for Drug Evaluation and
Research, International Programs, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, Rm. 1174, Rockville, MD 20993-0002, 301-
796-8377.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies.
ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers Association; CDER and CBER, FDA;
and the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
In the Federal Register of April 15, 2013 (72 FR 22269), FDA
published a notice announcing the availability of a draft guidance
entitled ``M7 Assessment and Control of DNA Reactive (Mutagenic)
Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk''
The notice gave interested persons an opportunity to submit comments by
June 14, 2013. Changes made to the guidance took into consideration
written comments received. Minor editorial changes were made to improve
clarity.
After consideration of the comments received and revisions to the
guidance, a final draft of the guidance was submitted to the ICH
Steering Committee and endorsed by the three participating regulatory
agencies in June 2014.
The guidance provides guidance on the regulation of genotoxic
impurities in new drug substances and drug products.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on this topic. It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
II. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments 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.
III. Electronic Access
Persons with access to the Internet may obtain the document at
https://www.regulations.gov, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
Dated: May 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12752 Filed 5-27-15; 8:45 am]
BILLING CODE 4164-01-P
