Submission for OMB Review; Comment Request, 63165-63166 [2018-26535]

Download as PDF 63165 Federal Register / Vol. 83, No. 235 / Friday, December 7, 2018 / Notices reauthorization of the Head Start program (Pub. L. 110–134), which calls for periodic assessments of Head Start’s quality and effectiveness. Respondents: Head Start children, parents of Head Start children, and Head Start teachers and Head Start staff. ANNUAL BURDEN ESTIMATES Total number of respondents Instrument FACES 2019 Classroom sampling form from Head Start staff ................................................................................... FACES 2019 Child roster form from Head Start staff ......... FACES 2019 Parent consent form ...................................... FACES 2019 Head Start parent survey .............................. FACES 2019 Head Start child assessment ........................ FACES 2019 Head Start teacher child report ..................... FACES 2019 Head Start teacher survey ............................ FACES 2019 Head Start program director survey .............. FACES 2019 Head Start center director survey ................. AI/AN FACES 2019 Classroom sampling form from Head Start staff .......................................................................... AI/AN FACES 2019 Child roster form from Head Start staff ................................................................................... AI/AN FACES 2019 Parent consent form ........................... AI/AN FACES 2019 Head Start parent survey .................... AI/AN FACES 2019 Head Start child assessment .............. AI/AN FACES 2019 Head Start teacher child report .......... AI/AN FACES 2019 Head Start teacher survey .................. AI/AN FACES 2019 Head Start program director survey ... AI/AN FACES 2019 Head Start center director survey ....... Estimated Total Annual Burden Hours: 3,357. Authority: Section 640(a)(2)(D) and section 649 of the Improving Head Start for School Readiness Act of 2007. Annual number of respondents BILLING CODE 4184–01–P Annual burden hours 120 40 800 800 800 80 240 60 120 1 1 1 2 2 20 1 1 1 0.17 0.33 0.17 0.42 0.75 0.17 0.50 0.50 0.50 20 13 136 672 1,200 272 120 30 60 37 13 1 0.17 2 37 800 800 800 80 80 22 37 13 267 267 267 27 27 8 13 1 1 2 2 20 1 1 1 0.33 0.17 0.50 0.75 0.17 0.58 0.33 0.33 4 45 267 401 92 16 3 4 DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Title: OCSE–157 Child Support Enforcement Program Annual Data Report. OMB No.: 0970–0177. Description: The information obtained from this form will be used to: (1) Report Child Support Enforcement activities to the Congress as required by [FR Doc. 2018–26563 Filed 12–6–18; 8:45 am] Average burden hours per response 360 120 2,400 2,400 2,400 240 720 180 360 Submission for OMB Review; Comment Request Mary B. Jones, ACF/OPRE Certifying Officer. Number of responses per respondent law; (2) calculate incentive measures performance and performance indicators utilized in the program; and (3) assist the Office of Child Support Enforcement (OCSE) in monitoring and evaluating State Child Support programs. OCSE is proposing updates to the OCSE–157 report instructions to update and clarify reporting requirements. Respondents are encouraged to contact the agency to obtain a copy of the revised instructions for review and comment. Respondents: State, Local or Tribal Government. amozie on DSK3GDR082PROD with NOTICES ANNUAL BURDEN ESTIMATES Instrument Number of respondents Number of responses per respondent Average burden hours per response Total burden hours OCSE–157 ....................................................................................................... 54 1 7 378 Estimated Total Annual Burden Hours: 378. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW, Washington, DC 20201. Attention Reports Clearance Officer. All requests should be identified by the title VerDate Sep<11>2014 16:56 Dec 06, 2018 Jkt 247001 of the information collection. Email address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the 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 PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 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: E:\FR\FM\07DEN1.SGM 07DEN1 63166 Federal Register / Vol. 83, No. 235 / Friday, December 7, 2018 / Notices Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2018–26535 Filed 12–6–18; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–3380] Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products; 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 guidance for industry entitled ‘‘Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products.’’ This draft guidance describes considerations for the development and labeling of in vitro companion diagnostic devices (referred to as companion diagnostics in this document) to support the indicated uses of multiple drug or biologic oncology products (referred to as therapeutic products or oncology therapeutic products in this document), when appropriate. The draft guidance includes factors for considering when broader labeling (i.e., labeling that is expanded) of a companion diagnostic would be appropriate. Oncology companion diagnostics with broader evidence-based indications will optimally facilitate clinical use. DATES: Submit either electronic or written comments on the draft guidance by February 5, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: SUMMARY: amozie on DSK3GDR082PROD 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 VerDate Sep<11>2014 16:56 Dec 06, 2018 Jkt 247001 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– 2018–D–3380 for ‘‘Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products.’’ 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 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 PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002; the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002; or the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. The draft guidance may also be obtained by mail by calling FDA’s Center for Biologics Evaluation and Research (CBER) at 1–800–835– 4709 or 240–402–8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911; Reena Philip, Center for E:\FR\FM\07DEN1.SGM 07DEN1

Agencies

[Federal Register Volume 83, Number 235 (Friday, December 7, 2018)]
[Notices]
[Pages 63165-63166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26535]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Submission for OMB Review; Comment Request

    Title: OCSE-157 Child Support Enforcement Program Annual Data 
Report.
    OMB No.: 0970-0177.
    Description: The information obtained from this form will be used 
to: (1) Report Child Support Enforcement activities to the Congress as 
required by law; (2) calculate incentive measures performance and 
performance indicators utilized in the program; and (3) assist the 
Office of Child Support Enforcement (OCSE) in monitoring and evaluating 
State Child Support programs.
    OCSE is proposing updates to the OCSE-157 report instructions to 
update and clarify reporting requirements. Respondents are encouraged 
to contact the agency to obtain a copy of the revised instructions for 
review and comment.
    Respondents: State, Local or Tribal Government.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                  Number of      Average burden
                 Instrument                      Number of      responses per      hours per       Total burden
                                                respondents       respondent        response          hours
----------------------------------------------------------------------------------------------------------------
OCSE-157....................................              54                1                7              378
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 378.
    Additional Information: Copies of the proposed collection may be 
obtained by writing to the Administration for Children and Families, 
Office of Planning, Research and Evaluation, 330 C Street SW, 
Washington, DC 20201. Attention Reports Clearance Officer. All requests 
should be identified by the title of the information collection. Email 
address: [email protected].
    OMB Comment: OMB is required to make a decision concerning the 
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: 
[email protected]. Attn:

[[Page 63166]]

Desk Officer for the Administration for Children and Families.

Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2018-26535 Filed 12-6-18; 8:45 am]
 BILLING CODE 4184-01-P