Identifying Potential Biomarkers for Qualification and Describing Contexts of Use To Address Areas Important to Drug Development; Extension of Comment Period, 18244 [2015-07631]

Download as PDF 18244 Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–2187] Identifying Potential Biomarkers for Qualification and Describing Contexts of Use To Address Areas Important to Drug Development; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. The Food and Drug Administration (FDA) is extending the comment period for the notice entitled ‘‘Identifying Potential Biomarkers for Qualification and Describing Contexts of Use to Address Areas Important to Drug Development; Request for Comments’’ that appeared in the Federal Register of February 13, 2015 (80 FR 8089). In the notice, FDA requested comments on identifying potential biomarkers for qualification and describing contexts of use to address areas important to drug development. The Agency is taking this action for an extension to allow interested persons additional time to submit comments. DATES: Submit either electronic or written comments by May 15, 2015 ADDRESSES: Submit electronic comments 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: Marianne Noone, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 4528, Silver Spring, MD 20993–0002, 301– 796–7495. SUMMARY: SUPPLEMENTARY INFORMATION: asabaliauskas on DSK5VPTVN1PROD with NOTICES I. Background In the Federal Register of February 13, 2015 (80 FR 8089), FDA published a notice with a 60-day comment period to request comments on identifying potential biomarkers for qualification and describing contexts of use to address areas important to drug development. FDA is encouraging interested groups and individuals to submit information on specific medical and biological areas where novel biomarkers can be identified that would VerDate Sep<11>2014 18:48 Apr 02, 2015 Jkt 235001 meaningfully advance drug development. The current 60-day comment period does not allow sufficient time to obtain the broad public response that will inform FDA’s Biomarker Qualification Program going forward. FDA is extending the comment period for an additional 30 days, thus extending the comment period to May 15, 2015. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying progress on these important issues. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Catherine Ramadei, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2015–07639 Filed 4–2–15; 8:45 am] BILLING CODE 4163–18–P II. Request for 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. Dated: March 30, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–07631 Filed 4–2–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Clinical Laboratory Improvement Advisory Committee Correction: This notice was published in the Federal Register on March 24, 2015, Volume 80, Number 56, Pages 15621–15622. The times and dates should read as follows: Times and Dates: 12:30 p.m.—5:00 p.m., April 15, 2015; 8:30 a.m.—12:00 p.m., April 16, 2015. CONTACT PERSON FOR ADDITIONAL INFORMATION: Nancy Anderson, Chief, Laboratory Practice Standards Branch, Division of Laboratory Programs, Standards, and Services, Center for Surveillance, Epidemiology and Laboratory Services, Office of Public Health Scientific Services, CDC, 1600 Clifton Road NE., Mailstop F–11, Atlanta, Georgia 30329–4018; telephone (404) 498–2741; or via email at NAnderson@cdc.gov PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 DEPARTMENT OF HOMELAND SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities: Extension, With Change, of an Existing Information Collection; Comment Request 60-Day Notice of Information collection for review; I–312/I–312A; Designation of Attorney in Fact/ Revocation of Attorney In Fact; OMB Control No. 1653–0041. ACTION: The Department of Homeland Security, U.S. Immigration and Customs Enforcement (ICE), is submitting the following information collection request for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection is published in the Federal Register to obtain comments from the public and affected agencies. Comments are encouraged and will be accepted for sixty days until June 2, 2015. Written comments and suggestions regarding items contained in this notice and especially with regard to the estimated public burden and associated response time should be directed to the Department of Homeland Security (DHS), Scott Elmore, Forms Management Office, U.S. Immigration and Customs Enforcement, 801 I Street NW., Mailstop 5800, Washington, DC 20536–5800. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information should address one or more of the following four points: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the E:\FR\FM\03APN1.SGM 03APN1

Agencies

[Federal Register Volume 80, Number 64 (Friday, April 3, 2015)]
[Notices]
[Page 18244]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07631]



[[Page 18244]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2187]


Identifying Potential Biomarkers for Qualification and Describing 
Contexts of Use To Address Areas Important to Drug Development; 
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period for the notice entitled ``Identifying Potential 
Biomarkers for Qualification and Describing Contexts of Use to Address 
Areas Important to Drug Development; Request for Comments'' that 
appeared in the Federal Register of February 13, 2015 (80 FR 8089). In 
the notice, FDA requested comments on identifying potential biomarkers 
for qualification and describing contexts of use to address areas 
important to drug development. The Agency is taking this action for an 
extension to allow interested persons additional time to submit 
comments.

DATES: Submit either electronic or written comments by May 15, 2015

ADDRESSES: Submit electronic comments 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: Marianne Noone, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 21, Rm. 4528, Silver Spring, MD 20993-0002, 301-
796-7495.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of February 13, 2015 (80 FR 8089), FDA 
published a notice with a 60-day comment period to request comments on 
identifying potential biomarkers for qualification and describing 
contexts of use to address areas important to drug development. FDA is 
encouraging interested groups and individuals to submit information on 
specific medical and biological areas where novel biomarkers can be 
identified that would meaningfully advance drug development.
    The current 60-day comment period does not allow sufficient time to 
obtain the broad public response that will inform FDA's Biomarker 
Qualification Program going forward. FDA is extending the comment 
period for an additional 30 days, thus extending the comment period to 
May 15, 2015. The Agency believes that a 30-day extension allows 
adequate time for interested persons to submit comments without 
significantly delaying progress on these important issues.

II. Request for 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.

    Dated: March 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07631 Filed 4-2-15; 8:45 am]
 BILLING CODE 4164-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.