81 FR 1632 - Clinical Outcome Assessment Compendium
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 8 (January 13, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 8 (January 13, 2016)
| Page Range | 1632-1633 | |
| FR Document | 2016-00529 |
[Federal Register Volume 81, Number 8 (Wednesday, January 13, 2016)] [Notices] [Pages 1632-1633] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-00529] ======================================================================= ----------------------------------------------------------------------- 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: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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 http://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: http://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 http://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: [email protected]. 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: http://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: http://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
![1632 Federal Register / Vol. 81, No. 8 / Wednesday, January 13, 2016 / Notices
Board of Governors of the Federal Reserve DEPARTMENT OF HEALTH AND detailed (see ‘‘Written/Paper
System, January 7, 2016. HUMAN SERVICES Submissions’’ and ‘‘Instructions’’).
Robert deV. Frierson,
Food and Drug Administration Written/Paper Submissions
Secretary of the Board.
Submit written/paper submissions as
[FR Doc. 2016–00441 Filed 1–12–16; 8:45 am] [Docket No. FDA–2015–N–5106]
follows:
BILLING CODE 6210–01–P
Clinical Outcome Assessment • Mail/Hand delivery/Courier (for
Compendium written/paper submissions): Division of
Dockets Management (HFA–305), Food
FEDERAL RESERVE SYSTEM AGENCY: Food and Drug Administration, and Drug Administration, 5630 Fishers
HHS. Lane, Rm. 1061, Rockville, MD 20852.
Change in Bank Control Notices; ACTION: Notice; establishment of docket; • For written/paper comments
Acquisitions of Shares of a Bank or request for comments. submitted to the Division of Dockets
Bank Holding Company Management, FDA will post your
SUMMARY: The Food and Drug comment, as well as any attachments,
The notificants listed below have Administration (FDA or Agency) is except for information submitted,
applied under the Change in Bank announcing the establishment of a marked and identified, as confidential,
Control Act (12 U.S.C. 1817(j)) and docket to receive suggestions, if submitted as detailed in
§ 225.41 of the Board’s Regulation Y (12 recommendations, and comments from ‘‘Instructions.’’
CFR 225.41) to acquire shares of a bank interested parties (including academic Instructions: All submissions received
or bank holding company. The factors institutions, regulated industry, and must include the Docket No. FDA–
that are considered in acting on the patient groups) on our pilot ‘‘Clinical 2015–N–5106 for ‘‘Clinical Outcome
notices are set forth in paragraph 7 of Outcome Assessment Compendium’’ Assessment Compendium.’’ Received
the Act (12 U.S.C. 1817(j)(7)). (COA Compendium). FDA has comments will be placed in the docket
developed a Web site that describes the and, except for those submitted as
The notices are available for purpose of the pilot COA Compendium ‘‘Confidential Submissions,’’ publicly
immediate inspection at the Federal and provides background information. viewable at http://www.regulations.gov
Reserve Bank indicated. The notices Comments received on the pilot COA or at the Division of Dockets
also will be available for inspection at Compendium during its pilot phase will Management between 9 a.m. and 4 p.m.,
the offices of the Board of Governors. help FDA determine its utility, and may Monday through Friday.
Interested persons may express their assist FDA in developing future • Confidential Submissions—To
views in writing to the Reserve Bank iterations of the COA Compendium and submit a comment with confidential
indicated for that notice or to the offices identifying best methods for conveying information that you do not wish to be
of the Board of Governors. Comments COA Compendium information on made publicly available submit your
must be received not later than January FDA’s Web site. comments only as a written/paper
28, 2016. DATES: Submit either electronic or submission. You should submit two
A. Federal Reserve Bank of Kansas written comments by March 14, 2016. copies total. One copy will include the
City (Dennis Denney, Assistant Vice ADDRESSES: You may submit comments information you claim to be confidential
as follows: with a heading or cover note that states
President) 1 Memorial Drive, Kansas
‘‘THIS DOCUMENT CONTAINS
City, Missouri 64198–0001: Electronic Submissions CONFIDENTIAL INFORMATION.’’ The
1. Kristina Davidson, Greenwood Submit electronic comments in the Agency will review this copy, including
Village, Colorado; and Zachary following way: the claimed confidential information, in
Davidson and Tiffany Davidson, both of • Federal eRulemaking Portal: http:// its consideration of comments. The
Nine Mile Falls, Washington; Shauna www.regulations.gov. Follow the second copy, which will have the
Cumin and Macaulay Kerr, both of instructions for submitting comments. claimed confidential information
Billings, Montana; Robert Kerr, Spokane Comments submitted electronically, redacted/blacked out, will be available
Washington; Scott Kerr, Satellite Beach, including attachments, to http:// for public viewing and posted on http:
Florida; the Joshua K. Davidson www.regulations.gov will be posted to //www.regulations.gov. Submit both
Irrevocable Trust, Brighton, Colorado; the docket unchanged. Because your copies to the Division of Dockets
and the Michelle M. Davidson comment will be made public, you are Management. If you do not wish your
Irrevocable Trust, Englewood, Colorado, solely responsible for ensuring that your name and contact information to be
as members of the Davidson Family comment does not include any made publicly available, you can
group and acting in concert; to retain confidential information that you or a provide this information on the cover
voting shares of First American third party may not wish to be posted, sheet and not in the body of your
Bancorp, and thereby indirectly retain such as medical information, your or comments and you must identify this
anyone else’s Social Security number, or information as ‘‘confidential.’’ Any
voting shares of First American State
confidential business information, such information marked as ‘‘confidential’’
Bank, both in Greenwood Village,
as a manufacturing process. Please note will not be disclosed except in
Colorado.
that if you include your name, contact accordance with 21 CFR 10.20 and other
Board of Governors of the Federal Reserve information, or other information that applicable disclosure law. For more
asabaliauskas on DSK5VPTVN1PROD with NOTICES
System, January 8, 2016. identifies you in the body of your information about FDA’s posting of
Margaret McCloskey Shanks, comments, that information will be comments to public dockets, see 80 FR
Deputy Secretary of the Board. posted on http://www.regulations.gov. 56469, September 18, 2015, or access
[FR Doc. 2016–00512 Filed 1–12–16; 8:45 am]
• If you want to submit a comment the information at: http://www.fda.gov/
with confidential information that you regulatoryinformation/dockets/
BILLING CODE 6210–01–P
do not wish to be made available to the default.htm.
public submit the comment as a written/ Docket: For access to the docket to
paper submission and in the manner read background documents or the
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![Federal Register / Vol. 81, No. 8 / Wednesday, January 13, 2016 / Notices 1633
electronic and written/paper comments www.fda.gov/COACompendium. of having their full effect if received
received, go to http:// Specifically, FDA welcomes your within 60 days of the date of this
www.regulations.gov and insert the comments concerning: (1) The utility of publication.
docket number, found in brackets in the the COA Compendium; (2) the best
heading of this document, into the approach for developing future FOR FURTHER INFORMATION CONTACT: To
‘‘Search’’ box and follow the prompts iterations of it, including any suggested obtain a copy of the data collection
and/or go to the Division of Dockets expansions of its scope; and (3) COA plans and instruments, submit
Management, 5630 Fishers Lane, Rm. Compendium-related questions you comments in writing, or request more
1061, Rockville, MD 20852. would like FDA to address in its future information on the proposed project,
communications. FDA will consider all contact: Anthony Kerlavage, NCI CBIIT,
FOR FURTHER INFORMATION CONTACT:
comments submitted but will generally Program Manager, 9609 Medical Center
Nikunj B. Patel, Clinical Outcome Drive, Room 1W–436, Rockville, MD
Assessments Staff (formerly Study not respond directly to the person or
organization submitting the comment. 20850 or call non-toll-free number 240–
Endpoints and Labeling Development 276–5190 or email your request,
(SEALD)), Office of New Drugs, Center Dated: January 7, 2016.
including your address to:
for Drug Evaluation and Research, Food Leslie Kux, anthony.kerlavage@nih.gov. Formal
and Drug Administration, 10903 New Associate Commissioner for Policy. requests for additional plans and
Hampshire Ave., Bldg. 22, Rm. 6369, [FR Doc. 2016–00529 Filed 1–12–16; 8:45 am] instruments must be requested in
Silver Spring, MD 20993–0002, 240– BILLING CODE 4164–01–P writing.
402–6502, email: COACompendium@
fda.hhs.gov. SUPPLEMENTARY INFORMATION:
SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND Proposed Collection: Cancer
HUMAN SERVICES Genomics Cloud Pilots Survey, 0925–
I. Background NEW, National Cancer Institute (NCI),
Capturing outcomes that are National Institutes of Health National Institutes of Health (NIH).
important to patients in clinical trials is Proposed Collection; 60-Day Comment Need and Use of Information
a high priority for FDA. The pilot COA Request; Cancer Genomics Cloud Collection: The Center for Biomedical
Compendium is part of FDA’s efforts to Pilots Survey (NCI) Informatics and Information Technology
foster patient-focused drug (CBIIT), in collaboration with the Center
development.1 The COA Compendium SUMMARY: In compliance with the for Cancer Genomics at the National
is intended to facilitate communication requirement of Section 3506(c)(2)(A) of Cancer Instititues (NCI) in the National
and to provide clarity and transparency the Paperwork Reduction Act of 1995, Institutes of Health (NIH), is
to drug developers and the research for opportunity for public comment on coordinating a program to develop three
community by collating and proposed data collection projects, the Cancer Genomics Cloud Pilots to help
summarizing clinical outcome National Cancer Institute, the National meet the research community’s needs to
assessment information for many Institutes of Health (NIH) will publish access and analyze high quality, large-
different diseases and conditions into a periodic summaries of proposed scale cancer genomic data and
single resource. It can be used as a projects to be submitted to the Office of associated clinical information. The goal
starting point when considering how Management and Budget (OMB) for of this effort is to develop an innovative,
certain clinical outcome assessments review and approval.
cost-effective model for computational
might be utilized in clinical trials and Written comments and/or suggestions
analysis of biological data and provide
will likely be most informative in early from the public and affected agencies
are invited to address one or more of the broader yet secure access to genomic
drug development. The public is data that NCI generates. Cloud
referred to the following FDA Web site following points: Whether the proposed
collection of information is necessary computing will be a valuable tool to
for additional background information, support studies related to the
along with the pilot COA Compendium: for the proper performance of the
function of the agency, including mechanisms of cancer. This capability
http://www.fda.gov/COACompendium. will be equally valuable to other NCI
whether the information will have
II. Establishment of a Docket and practical utility; The accuracy of the scientific areas, including clinical trials
Request for Comments agency’s estimate of the burden of the and other types of patient-focused
proposed collection of information, research. In order to understand the
To help FDA determine the utility of utility and value of the tools being
the COA Compendium, develop future including the validity of the
methodology and assumptions used; developed, the NCI has developed a
iterations of the COA Compendium, and survey instrument to capture feedback
identify best methods for conveying The quality, utility, and clarity of the
information to be collected; and from the cancer research community.
COA Compendium information on The information collected as part of this
FDA’s Web site, FDA is launching the Minimize the burden of the collection of
information on those who are to survey process will be used exclusively
pilot COA Compendium and soliciting by the NCI to determine future funding
public suggestions, recommendations, respond, including the use of
appropriate automated, electronic, of cloud technology projects.
and comments for each aspect of the
mechanical, or other technological OMB approval is requested for 3
COA Compendium mentioned on the
collection techniques or other forms of years. There are no costs to respondents
asabaliauskas on DSK5VPTVN1PROD with NOTICES
following FDA Web site: http://
information technology. other than their time. The total
1 The term drug, as used in this notice, refers to DATES: Comments regarding this estimated annualized burden hours are
human drugs including biological products. information collection are best assured 375.
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Document Created: 2016-01-13 01:00:41
Document Modified: 2016-01-13 01:00:41
| 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; establishment of docket; request for comments. | |
| Dates | Submit either electronic or written comments by March 14, 2016. | |
| 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: [email protected] | |
| FR Citation | 81 FR 1632 |
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