82 FR 54348 - Cardiac Troponin Assays; Public Workshop; Request for Comments; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 221 (November 17, 2017)

Page Range		54348-54349
FR Document		2017-24922

The Food and Drug Administration (FDA or Agency) is extending the comment period provided in the notice entitled ``Cardiac Troponin Assays; Public Workshop; Request for Comments'' that appeared in the Federal Register on July 31, 2017. That notice announced the public workshop and requested comments by November 28, 2017; FDA is extending the public workshop's comment period by 30 days to December 28, 2017, in response to requests for an extension to allow interested persons additional time to submit comments.

Federal Register, Volume 82 Issue 221 (Friday, November 17, 2017)

[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)]
[Notices]
[Pages 54348-54349]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-24922]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4179]


Cardiac Troponin Assays; Public Workshop; Request for Comments; 
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is extending 
the comment period provided in the notice entitled ``Cardiac Troponin 
Assays; Public Workshop; Request for Comments'' that appeared in the 
Federal Register on July 31, 2017. That notice announced the public 
workshop and requested comments by November 28, 2017; FDA is extending 
the public

[[Page 54349]]

workshop's comment period by 30 days to December 28, 2017, in response 
to requests for an extension to allow interested persons additional 
time to submit comments.

DATES: FDA is extending the comment period for the public workshop 
``Cardiac Troponin Assays'' published on July 31, 2017 (82 FR 35532). 
Submit either electronic or written comments by December 28, 2017.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before December 28, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of December 28, 2017. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2017-N-4179 for ``Cardiac Troponin Assays; Public Workshop; Request 
for Comments.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 Dockets Management Staff. 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.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the 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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Paula Caposino, Food and Drug 
Administration, Center for Devices and Radiological Health, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 4644, Silver Spring, MD 20993, 301-796-
6160, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of July 31, 2017 (82 
FR 35532), FDA published a notice announcing the public workshop 
entitled ``Cardiac Troponin Assays; Public Workshop; Request for 
Comments'' with a 120-day comment period to request comments.
    The Agency has received requests for a 30-day extension of the 
comment period for the public workshop. The request conveyed concern 
that the current 120-day comment period does not allow sufficient time 
to develop a meaningful or thoughtful response to the public workshop.
    FDA has considered the request and is extending the comment period 
for the public workshop for 30 days, until December 28, 2017. The 
Agency believes that a 30-day extension allows adequate time for 
interested persons to submit comments.

    Dated: November 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-24922 Filed 11-16-17; 8:45 am]
BILLING CODE 4164-01-P

54348 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices

collection of information between 30 Community Services Block Grant questions for clarity and system
and 60 days after publication of this (CSBG) State Plan Application for compatibility. It is not anticipated that
document in the Federal Register. States these revisions will cause any
Therefore, a comment is best assured of Community Services Block Grant additional burden to states as they have
having its full effect if OMB receives it (CSBG) Eligible Entity Master List been completing the automated plan for
within 30 days of publication. Written Community Services Block Grant three years. It is anticipated that the
comments and recommendations for the (CSBG) ACSI Survey of Eligible burden will continue to diminish in
proposed information collection should Entities subsequent years due to improved
be sent directly to the following: Office Title: Community Services Block automation.
of Management and Budget, Paperwork Grant (CSBG) State Plan Application In addition to the CSBG State Plan,
Reduction Project, Email: OIRA_ OMB Number: 0970–0382 states will be requested to complete a
SUBMISSION@OMB.EOP.GOV, Attn: Description: Section 676 of the CSBG Eligible Entity Master List in year
Desk Officer for the Administration for Community Services Block Grant one, and then make updates as
Children and Families. (CSBG) Act requires states, including necessary in subsequent years. As the
the District of Columbia and the states have the information about their
Mary Jones, Commonwealth of Puerto Rico, and U.S. eligible entities (or sub-grantees), the
ACF/OPRE Certifying Officer. territories applying for CSBG funds to burden will be minimal to the states to
[FR Doc. 2017–24901 Filed 11–16–17; 8:45 am] submit an application and plan (CSBG complete this the first year.
BILLING CODE 4184–23–P
State Plan). The CSBG State Plan must Lastly, the request includes a survey
meet statutory requirements prior to for the CSBG eligible entities (or sub-
states and territories being funded with grantees). The survey focuses on the
DEPARTMENT OF HEALTH AND CSBG funds. Applicants have the option customer service that the eligible
HUMAN SERVICES to submit a detailed plan annually or entities receive from the CSBG states.
biannually. Entities that submit a The survey is optional, and this will be
Administration for Children and biannual plan must provide an the third time that the eligible entities
Families abbreviated plan the following year if that chose to submit will complete it.
substantial changes to the initial plan Respondents: State Governments,
Proposed Information Collection will occur. including the District of Columbia and
Activity: Comment Request This request is to revise the the Commonwealth of Puerto Rico, and
automated CSBG State Plan format for U.S. territories, and local level sub-
Proposed Projects: states and territories by revising grantees.

ANNUAL BURDEN ESTIMATES
Average
Number of
Number of burden hours Total burden
Instrument responses per
respondents per hours
respondent response

CSBG State Plan Application for States ......................................................... 56 1 31 1,736
CSBG State Plan Eligible Entity List ............................................................... 56 1 1 56
CSBG ACSI Survey of Eligible Entities ........................................................... 1,019 1 .15 152.85

Estimated Total Annual Burden functions of the agency, including DEPARTMENT OF HEALTH AND
Hours: 1,792 hours for states and whether the information shall have HUMAN SERVICES
territories; 152.85 for eligible entities. practical utility; (b) the accuracy of the
In compliance with the requirements agency’s estimate of the burden of the Food and Drug Administration
of the Paperwork Reduction Act of 1995 proposed collection of information; (c)
(Pub. L. 104–13, 44 U.S.C. Chap. 35), the the quality, utility, and clarity of the [Docket No. FDA–2017–N–4179]
Administration for Children and information to be collected; and (d)
Families is soliciting public comment Cardiac Troponin Assays; Public
ways to minimize the burden of the Workshop; Request for Comments;
on the specific aspects of the collection of information on
information collection described above. Extension of Comment Period
respondents, including through the use
Copies of the proposed collection of of automated collection techniques or AGENCY: Food and Drug Administration,
information can be obtained and other forms of information technology. HHS.
comments may be forwarded by writing Consideration will be given to ACTION: Notice; extension of comment
to the Administration for Children and comments and suggestions submitted period.
Families, Office of Planning, Research
within 60 days of this publication.
and Evaluation, 330 C Street SW., SUMMARY: The Food and Drug
Washington, DC 20201. Attn: ACF Robert Sargis, Administration (FDA or Agency) is
Reports Clearance Officer. Email extending the comment period provided
sradovich on DSK3GMQ082PROD with NOTICES

Reports Clearance Officer.
address: infocollection@acf.hhs.gov. All [FR Doc. 2017–24905 Filed 11–16–17; 8:45 am] in the notice entitled ‘‘Cardiac Troponin
requests should be identified by the title Assays; Public Workshop; Request for
BILLING CODE 4184–27–P
of the information collection. Comments’’ that appeared in the
The Department specifically requests Federal Register on July 31, 2017. That
comments on: (a) Whether the proposed notice announced the public workshop
collection of information is necessary and requested comments by November
for the proper performance of the 28, 2017; FDA is extending the public

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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; extension of comment period.
Dates		FDA is extending the comment period for the public workshop ``Cardiac Troponin Assays'' published on July 31, 2017 (82 FR 35532). Submit either electronic or written comments by December 28, 2017.
Contact		Paula Caposino, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 4644, Silver Spring, MD 20993, 301-796- 6160, [email protected]
FR Citation		82 FR 54348

82 FR 54348 - Cardiac Troponin Assays; Public Workshop; Request for Comments; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 221 (November 17, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration