80 FR 30466 - Radiation Biodosimetry Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 102 (May 28, 2015)

Page Range		30466-30467
FR Document		2015-12854

The Food and Drug Administration (FDA) is reopening the comment period for an additional 30 days, for the notice of availability entitled ``Radiation Biodosimetry Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability'', published in the Federal Register of December 30, 2014. In that document, FDA announced the availability of a draft guidance for industry and FDA staff and requested comments. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

Federal Register, Volume 80 Issue 102 (Thursday, May 28, 2015)

[Federal Register Volume 80, Number 102 (Thursday, May 28, 2015)]
[Notices]
[Pages 30466-30467]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-12854]


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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Radiation Biodosimetry Devices; Draft Guidance for Industry and 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.

ACTION: Notice; reopening of the comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period for an additional 30 days, for the notice of 
availability

[[Page 30467]]

entitled ``Radiation Biodosimetry Devices; Draft Guidance for Industry 
and Food and Drug Administration Staff; Availability'', published in 
the Federal Register of December 30, 2014. In that document, FDA 
announced the availability of a draft guidance for industry and FDA 
staff and requested comments. The Agency is taking this action in 
response to a request for an extension to allow interested persons 
additional time to submit comments.

DATES: FDA is reopening and extending the comment period on the draft 
guidance. Submit either electronic or written comments by June 29, 
2015.

ADDRESSES: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the draft guidance document entitled 
``Radiation Biodosimetry Devices'' to the Office of the Center 
Director, Guidance and Policy Development, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
request.
    Submit electronic comments on the draft guidance to http://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. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jennifer Dickey, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5262, Silver Spring, MD 20993-0002, 301-
796-5028.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 30, 2014 (79 FR 78448), FDA 
published a notice with a 90-day comment period to request comments on 
the draft guidance for industry and FDA staff entitled ``Radiation 
Biodosimetry Devices''.
    The Agency received a request for an extension of the comment 
period for the draft guidance (Docket No. FDA-2014-D-2065-0005). The 
request conveyed concern that the current 90-day comment period does 
not allow sufficient time to respond. FDA has considered the request 
and is reopening and extending the comment period for the draft 
guidance for 30 days. The Agency believes that a 30-day extension 
allows adequate time for interested persons to submit comments without 
significantly delaying further FDA action on this guidance document.

II. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the Internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. Persons 
unable to download an electronic copy of ``Radiation Biodosimetry 
Devices'' may send an email request to [email protected] to 
receive an electronic copy of the document. Please use the document 
number 1400045 to identify the guidance you are requesting.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://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 http://www.regulations.gov.

    Dated: May 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.12854
[FR Doc. 2015-12854 Filed 5-27-15; 8:45 am]
 BILLING CODE 4164-01-P

30466 Federal Register / Vol. 80, No. 102 / Thursday, May 28, 2015 / Notices

Requirements for Registration of I. Background participating regulatory agencies in June
Pharmaceuticals for Human Use (ICH). 2014.
The guidance emphasizes In recent years, many important The guidance provides guidance on
considerations of both safety and quality initiatives have been undertaken by the regulation of genotoxic impurities in
risk management in establishing levels regulatory authorities and industry new drug substances and drug products.
of mutagenic impurities that are associations to promote international This guidance is being issued
expected to pose negligible carcinogenic harmonization of regulatory consistent with FDA’s good guidance
risk. It outlines recommendations for requirements. FDA has participated in practices regulation (21 CFR 10.115).
assessment and control of mutagenic many meetings designed to enhance The guidance represents the current
impurities that reside or are reasonably harmonization and is committed to thinking of FDA on this topic. It does
expected to reside in a final drug seeking scientifically based harmonized not establish any rights for any person
substance or product, taking into technical procedures for pharmaceutical and is not binding on FDA or the public.
consideration the intended conditions development. One of the goals of You can use an alternative approach if
of human use. The guidance is intended harmonization is to identify and then it satisfies the requirements of the
to provide guidance for new drug reduce differences in technical applicable statutes and regulations.
substances and new drug products requirements for drug development
among regulatory agencies. II. Comments
during their clinical development and
subsequent applications for marketing. ICH was organized to provide an Interested persons may submit either
opportunity for tripartite harmonization electronic comments regarding this
DATES: Submit either electronic or initiatives to be developed with input document to http://www.regulations.gov
written comments on Agency guidances from both regulatory and industry or written comments to the Division of
at any time. representatives. FDA also seeks input Dockets Management (see ADDRESSES). It
ADDRESSES: Submit written requests for from consumer representatives and is only necessary to send one set of
single copies of the guidance to the others. ICH is concerned with comments. Identify comments with the
Division of Drug Information (HFD– harmonization of technical docket number found in brackets in the
240), Center for Drug Evaluation and requirements for the registration of heading of this document. Received
Research (CDER), Food and Drug pharmaceutical products among three comments may be seen in the Division
Administration, 10001 New Hampshire regions: The European Union, Japan, of Dockets Management between 9 a.m.
Ave., Hillandale Building, 4th Floor, and the United States. The six ICH and 4 p.m., Monday through Friday, and
Silver Spring, MD 20993; or the Office sponsors are the European Commission; will be posted to the docket at http://
of Communication, Outreach, and the European Federation of www.regulations.gov.
Development, Center for Biologics Pharmaceutical Industries Associations; III. Electronic Access
Evaluation and Research (CBER), Food the Japanese Ministry of Health, Labour,
and Welfare; the Japanese Persons with access to the Internet
and Drug Administration, 10903 New may obtain the document at http://
Hampshire Ave., Bldg. 71, Rm. 3128, Pharmaceutical Manufacturers
Association; CDER and CBER, FDA; and www.regulations.gov, http://www.fda.
Silver Spring, MD 20993–0002. Send gov/Drugs/GuidanceCompliance
one self-addressed adhesive label to the Pharmaceutical Research and
Manufacturers of America. The ICH RegulatoryInformation/Guidances/
assist the office in processing your default.htm, or http://www.fda.gov/
requests. The guidance may also be Secretariat, which coordinates the
preparation of documentation, is BiologicsBloodVaccines/Guidance
obtained by mail by calling CBER at 1– ComplianceRegulatoryInformation/
800–835–4709 or 240–402–7800. See provided by the International
Federation of Pharmaceutical Guidances/default.htm.
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance Manufacturers Associations (IFPMA). Dated: May 20, 2015.
document. The ICH Steering Committee includes Leslie Kux,
representatives from each of the ICH Associate Commissioner for Policy.
Submit electronic comments on the
sponsors and the IFPMA, as well as [FR Doc. 2015–12752 Filed 5–27–15; 8:45 am]
guidance to http://www.regulations.gov.
observers from the World Health BILLING CODE 4164–01–P
Submit written comments to the
Organization, Health Canada, and the
Division of Dockets Management (HFA–
European Free Trade Area.
305), Food and Drug Administration,
In the Federal Register of April 15, DEPARTMENT OF HEALTH AND
5630 Fishers Lane, Rm. 1061, Rockville,
2013 (72 FR 22269), FDA published a HUMAN SERVICES
MD 20852.
notice announcing the availability of a
FOR FURTHER INFORMATION CONTACT: draft guidance entitled ‘‘M7 Assessment Food and Drug Administration
Regarding the guidance: Aisar and Control of DNA Reactive [Docket No. FDA–2014–D–2065]
Atrakchi, Center for Drug Evaluation (Mutagenic) Impurities in
and Research, Food and Drug Pharmaceuticals to Limit Potential Radiation Biodosimetry Devices; Draft
Administration, Bldg. 22, Rm. 4118, Carcinogenic Risk’’ The notice gave Guidance for Industry and Food and
Silver Spring, MD 20993–0002, 301– interested persons an opportunity to Drug Administration Staff; Extension
796–1036. submit comments by June 14, 2013. of Comment Period
Changes made to the guidance took into
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Regarding the ICH: Michelle Limoli, AGENCY: Food and Drug Administration,
consideration written comments HHS.
Center for Drug Evaluation and
received. Minor editorial changes were
Research, International Programs, Food Notice; reopening of the
ACTION:
made to improve clarity.
and Drug Administration, 10903 New comment period.
Hampshire Ave., Bldg. 51, Rm. 1174, After consideration of the comments
Rockville, MD 20993–0002, 301–796– received and revisions to the guidance, SUMMARY: The Food and Drug
8377. a final draft of the guidance was Administration (FDA) is reopening the
submitted to the ICH Steering comment period for an additional 30
SUPPLEMENTARY INFORMATION: Committee and endorsed by the three days, for the notice of availability

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Document Created: 2018-02-21 10:33:03
Document Modified: 2018-02-21 10:33:03

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; reopening of the comment period.
Dates		FDA is reopening and extending the comment period on the draft guidance. Submit either electronic or written comments by June 29, 2015.
Contact		Jennifer Dickey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5262, Silver Spring, MD 20993-0002, 301- 796-5028.
FR Citation		80 FR 30466

80 FR 30466 - Radiation Biodosimetry Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 102 (May 28, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration