Cardiac Troponin Assays; Public Workshop; Request for Comments; Extension of Comment Period, 54348-54349 [2017-24922]

Download as PDF 54348 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: OIRA_ SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Mary Jones, ACF/OPRE Certifying Officer. [FR Doc. 2017–24901 Filed 11–16–17; 8:45 am] BILLING CODE 4184–23–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity: Comment Request Proposed Projects: Community Services Block Grant (CSBG) State Plan Application for States Community Services Block Grant (CSBG) Eligible Entity Master List Community Services Block Grant (CSBG) ACSI Survey of Eligible Entities Title: Community Services Block Grant (CSBG) State Plan Application OMB Number: 0970–0382 Description: Section 676 of the Community Services Block Grant (CSBG) Act requires states, including the District of Columbia and the Commonwealth of Puerto Rico, and U.S. territories applying for CSBG funds to submit an application and plan (CSBG State Plan). The CSBG State Plan must meet statutory requirements prior to states and territories being funded with CSBG funds. Applicants have the option to submit a detailed plan annually or biannually. Entities that submit a biannual plan must provide an abbreviated plan the following year if substantial changes to the initial plan will occur. This request is to revise the automated CSBG State Plan format for states and territories by revising questions for clarity and system compatibility. It is not anticipated that these revisions will cause any additional burden to states as they have been completing the automated plan for three years. It is anticipated that the burden will continue to diminish in subsequent years due to improved automation. In addition to the CSBG State Plan, states will be requested to complete a CSBG Eligible Entity Master List in year one, and then make updates as necessary in subsequent years. As the states have the information about their eligible entities (or sub-grantees), the burden will be minimal to the states to complete this the first year. Lastly, the request includes a survey for the CSBG eligible entities (or subgrantees). The survey focuses on the customer service that the eligible entities receive from the CSBG states. The survey is optional, and this will be the third time that the eligible entities that chose to submit will complete it. Respondents: State Governments, including the District of Columbia and the Commonwealth of Puerto Rico, and U.S. territories, and local level subgrantees. ANNUAL BURDEN ESTIMATES Number of respondents Instrument sradovich on DSK3GMQ082PROD with NOTICES CSBG State Plan Application for States ......................................................... CSBG State Plan Eligible Entity List ............................................................... CSBG ACSI Survey of Eligible Entities ........................................................... Estimated Total Annual Burden Hours: 1,792 hours for states and territories; 152.85 for eligible entities. In compliance with the requirements of the Paperwork Reduction Act of 1995 (Pub. L. 104–13, 44 U.S.C. Chap. 35), the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington, DC 20201. Attn: ACF Reports Clearance Officer. Email address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 56 56 1,019 functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Robert Sargis, Reports Clearance Officer. [FR Doc. 2017–24905 Filed 11–16–17; 8:45 am] BILLING CODE 4184–27–P PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 Number of responses per respondent 1 1 1 Average burden hours per response Total burden hours 31 1 .15 1,736 56 152.85 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. 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 SUMMARY: E:\FR\FM\17NON1.SGM 17NON1 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 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. sradovich on DSK3GMQ082PROD with NOTICES 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 VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 54349 Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 4644, Silver Spring, MD 20993, 301–796– 6160, Paula.Caposino@fda.hhs.gov. 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–D–6154] Evaluation of Devices Used With Regenerative Medicine Advanced Therapies; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ‘‘Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Draft Guidance for Industry.’’ The draft guidance document, when finalized, will provide device manufacturers, applicants, and sponsors engaged in the development of regenerative medicine therapies, with our current thinking regarding evaluation of devices used in the recovery, isolation or delivery of regenerative advanced therapies, which FDA generally refers to as ‘‘regenerative medicine advanced therapies’’ or ‘‘RMATs.’’ Specifically, as required by the 21st Century Cures Act (Cures Act), SUMMARY: E:\FR\FM\17NON1.SGM 17NON1

Agencies

[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)]
[Notices]
[Pages 54348-54349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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

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.gpo.gov/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, Paula.Caposino@fda.hhs.gov.

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