Clinical Outcome Assessment Compendium, 1632-1633 [2016-00529]

Download as PDF 1632 Federal Register / Vol. 81, No. 8 / Wednesday, January 13, 2016 / Notices Board of Governors of the Federal Reserve System, January 7, 2016. Robert deV. Frierson, Secretary of the Board. DEPARTMENT OF HEALTH AND HUMAN SERVICES detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Food and Drug Administration [FR Doc. 2016–00441 Filed 1–12–16; 8:45 am] [Docket No. FDA–2015–N–5106] BILLING CODE 6210–01–P Clinical Outcome Assessment Compendium FEDERAL RESERVE SYSTEM AGENCY: Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, 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– 2015–N–5106 for ‘‘Clinical Outcome Assessment Compendium.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 http: //www.regulations.gov. Submit both copies to the Division of Dockets Management. 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.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the Food and Drug Administration, HHS. Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company Notice; establishment of docket; request for comments. ACTION: The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to receive suggestions, recommendations, and comments from interested parties (including academic institutions, regulated industry, and patient groups) on our pilot ‘‘Clinical Outcome Assessment Compendium’’ (COA Compendium). FDA has developed a Web site that describes the purpose of the pilot COA Compendium and provides background information. Comments received on the pilot COA Compendium during its pilot phase will help FDA determine its utility, and may assist FDA in developing future iterations of the COA Compendium and identifying best methods for conveying COA Compendium information on FDA’s Web site. DATES: Submit either electronic or written comments by March 14, 2016. ADDRESSES: You may submit comments as follows: SUMMARY: asabaliauskas on DSK5VPTVN1PROD with NOTICES The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board’s Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)). The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than January 28, 2016. A. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198–0001: 1. Kristina Davidson, Greenwood Village, Colorado; and Zachary Davidson and Tiffany Davidson, both of Nine Mile Falls, Washington; Shauna Cumin and Macaulay Kerr, both of Billings, Montana; Robert Kerr, Spokane Washington; Scott Kerr, Satellite Beach, Florida; the Joshua K. Davidson Irrevocable Trust, Brighton, Colorado; and the Michelle M. Davidson Irrevocable Trust, Englewood, Colorado, as members of the Davidson Family group and acting in concert; to retain voting shares of First American Bancorp, and thereby indirectly retain voting shares of First American State Bank, both in Greenwood Village, Colorado. Board of Governors of the Federal Reserve System, January 8, 2016. Margaret McCloskey Shanks, Deputy Secretary of the Board. [FR Doc. 2016–00512 Filed 1–12–16; 8:45 am] BILLING CODE 6210–01–P VerDate Sep<11>2014 16:59 Jan 12, 2016 Jkt 238001 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, 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 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\13JAN1.SGM 13JAN1 Federal Register / Vol. 81, No. 8 / Wednesday, January 13, 2016 / Notices 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Nikunj B. Patel, Clinical Outcome Assessments Staff (formerly Study Endpoints and Labeling Development (SEALD)), Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6369, Silver Spring, MD 20993–0002, 240– 402–6502, email: COACompendium@ fda.hhs.gov. I. Background Capturing outcomes that are important to patients in clinical trials is a high priority for FDA. The pilot COA Compendium is part of FDA’s efforts to foster patient-focused drug development.1 The COA Compendium is intended to facilitate communication and to provide clarity and transparency to drug developers and the research community by collating and summarizing clinical outcome assessment information for many different diseases and conditions into a single resource. It can be used as a starting point when considering how certain clinical outcome assessments might be utilized in clinical trials and will likely be most informative in early drug development. The public is referred to the following FDA Web site for additional background information, along with the pilot COA Compendium: https://www.fda.gov/COACompendium. asabaliauskas on DSK5VPTVN1PROD with NOTICES II. Establishment of a Docket and Request for Comments To help FDA determine the utility of the COA Compendium, develop future iterations of the COA Compendium, and identify best methods for conveying COA Compendium information on FDA’s Web site, FDA is launching the pilot COA Compendium and soliciting public suggestions, recommendations, and comments for each aspect of the COA Compendium mentioned on the following FDA Web site: https:// 1 The term drug, as used in this notice, refers to human drugs including biological products. 16:59 Jan 12, 2016 Jkt 238001 Dated: January 7, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–00529 Filed 1–12–16; 8:45 am] BILLING CODE 4164–01–P of having their full effect if received within 60 days of the date of this publication. To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Anthony Kerlavage, NCI CBIIT, Program Manager, 9609 Medical Center Drive, Room 1W–436, Rockville, MD 20850 or call non-toll-free number 240– 276–5190 or email your request, including your address to: anthony.kerlavage@nih.gov. Formal requests for additional plans and instruments must be requested in writing. FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 www.fda.gov/COACompendium. Specifically, FDA welcomes your comments concerning: (1) The utility of the COA Compendium; (2) the best approach for developing future iterations of it, including any suggested expansions of its scope; and (3) COA Compendium-related questions you would like FDA to address in its future communications. FDA will consider all comments submitted but will generally not respond directly to the person or organization submitting the comment. 1633 National Institutes of Health Proposed Collection; 60-Day Comment Request; Cancer Genomics Cloud Pilots Survey (NCI) In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; The accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; The quality, utility, and clarity of the information to be collected; and Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. DATES: Comments regarding this information collection are best assured SUMMARY: PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 Proposed Collection: Cancer Genomics Cloud Pilots Survey, 0925– NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The Center for Biomedical Informatics and Information Technology (CBIIT), in collaboration with the Center for Cancer Genomics at the National Cancer Instititues (NCI) in the National Institutes of Health (NIH), is coordinating a program to develop three Cancer Genomics Cloud Pilots to help meet the research community’s needs to access and analyze high quality, largescale cancer genomic data and associated clinical information. The goal of this effort is to develop an innovative, cost-effective model for computational analysis of biological data and provide broader yet secure access to genomic data that NCI generates. Cloud computing will be a valuable tool to support studies related to the mechanisms of cancer. This capability will be equally valuable to other NCI scientific areas, including clinical trials and other types of patient-focused research. In order to understand the utility and value of the tools being developed, the NCI has developed a survey instrument to capture feedback from the cancer research community. The information collected as part of this survey process will be used exclusively by the NCI to determine future funding of cloud technology projects. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 375. E:\FR\FM\13JAN1.SGM 13JAN1

Agencies

[Federal Register Volume 81, Number 8 (Wednesday, January 13, 2016)]
[Notices]
[Pages 1632-1633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00529]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-5106]


Clinical Outcome Assessment Compendium

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the establishment of a docket to receive suggestions, recommendations, 
and comments from interested parties (including academic institutions, 
regulated industry, and patient groups) on our pilot ``Clinical Outcome 
Assessment Compendium'' (COA Compendium). FDA has developed a Web site 
that describes the purpose of the pilot COA Compendium and provides 
background information. Comments received on the pilot COA Compendium 
during its pilot phase will help FDA determine its utility, and may 
assist FDA in developing future iterations of the COA Compendium and 
identifying best methods for conveying COA Compendium information on 
FDA's Web site.

DATES: Submit either electronic or written comments by March 14, 2016.

ADDRESSES: You may submit comments as follows:

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, 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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2015-N-5106 for ``Clinical Outcome Assessment Compendium.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the

[[Page 1633]]

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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Nikunj B. Patel, Clinical Outcome 
Assessments Staff (formerly Study Endpoints and Labeling Development 
(SEALD)), Office of New Drugs, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 
6369, Silver Spring, MD 20993-0002, 240-402-6502, email: 
COACompendium@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    Capturing outcomes that are important to patients in clinical 
trials is a high priority for FDA. The pilot COA Compendium is part of 
FDA's efforts to foster patient-focused drug development.\1\ The COA 
Compendium is intended to facilitate communication and to provide 
clarity and transparency to drug developers and the research community 
by collating and summarizing clinical outcome assessment information 
for many different diseases and conditions into a single resource. It 
can be used as a starting point when considering how certain clinical 
outcome assessments might be utilized in clinical trials and will 
likely be most informative in early drug development. The public is 
referred to the following FDA Web site for additional background 
information, along with the pilot COA Compendium: https://www.fda.gov/COACompendium.
---------------------------------------------------------------------------

    \1\ The term drug, as used in this notice, refers to human drugs 
including biological products.
---------------------------------------------------------------------------

II. Establishment of a Docket and Request for Comments

    To help FDA determine the utility of the COA Compendium, develop 
future iterations of the COA Compendium, and identify best methods for 
conveying COA Compendium information on FDA's Web site, FDA is 
launching the pilot COA Compendium and soliciting public suggestions, 
recommendations, and comments for each aspect of the COA Compendium 
mentioned on the following FDA Web site: https://www.fda.gov/COACompendium. Specifically, FDA welcomes your comments concerning: (1) 
The utility of the COA Compendium; (2) the best approach for developing 
future iterations of it, including any suggested expansions of its 
scope; and (3) COA Compendium-related questions you would like FDA to 
address in its future communications. FDA will consider all comments 
submitted but will generally not respond directly to the person or 
organization submitting the comment.

    Dated: January 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-00529 Filed 1-12-16; 8:45 am]
BILLING CODE 4164-01-P
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