Agency Information Collection Request; 30-Day Public Comment Request, 8881 [2020-03128]

Download as PDF 8881 Federal Register / Vol. 85, No. 32 / Tuesday, February 18, 2020 / Notices 3. The date the application was approved: November 16, 2016. FDA has verified the applicant’s claim that NDA 208470 was approved on November 16, 2016. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 717 days or 518 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 690–7569. When submitting comments or requesting information, please include the document identifier 4040– 0019–30D and project title for reference. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Title of the Collections: Project Abstract Summary. Type of Collection: Revision. OMB No.: 4040–0019. Abstract: Project Abstract Summary form provides the Federal grant-making agencies an alternative to the Standard Form 424 data set and form. Project Abstract Summary programs are not required to collect all the data that is required on the SF–424 core data set and form. Grants.gov seeks revision without renewal and designation as a Common Form due to updates to the IC. The IC was modified to remove data elements. The IC was renewed with an expiration date of 02/28/2022 and does not require an extension. SUPPLEMENTARY INFORMATION: Dated: February 12, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–03115 Filed 2–14–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: OS–4040–0019] Agency Information Collection Request; 30-Day Public Comment Request Office of the Secretary, HHS. Notice. AGENCY: ACTION: In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. DATES: Comments on the ICR must be received on or before March 19, 2020. ADDRESSES: Submit your comments to OIRA_submission@omb.eop.gov or via facsimile to (202) 395–5806. FOR FURTHER INFORMATION CONTACT: Ed Calimag, ed.calimag@hhs.gov or (202) SUMMARY: ESTIMATED ANNUALIZED BURDEN TABLE Number of respondents Forms Project Abstract Summary ............................................................................... Total .......................................................................................................... Sherrette A. Funn, Paperwork Reduction Act Reports Clearance Officer, Office of the Secretary. [FR Doc. 2020–03128 Filed 2–14–20; 8:45 am] BILLING CODE 4151–AE–P lotter on DSKBCFDHB2PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the VerDate Sep<11>2014 17:48 Feb 14, 2020 Jkt 250001 3,467 3,467 following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Blood Brain Barrier. Date: March 19, 2020. PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 Number of responses per respondent Average burden hours per response 1 ........................ 1 ........................ Total burden hours 3,467 3,467 Time: 8:00 a.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda North Marriott Hotel & Conference Center, Montgomery County Conference Center Facility, 5701 Marinelli Road, North Bethesda, MD 20852. Contact Person: Michael P. Reilly, Ph.D., Scientific Review Officer, Office of Scientific Review, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Drive, Room 7200, Bethesda, MD 20892, 301–827–7975, reillymp@ nhlbi.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases E:\FR\FM\18FEN1.SGM 18FEN1

Agencies

[Federal Register Volume 85, Number 32 (Tuesday, February 18, 2020)]
[Notices]
[Page 8881]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03128]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: OS-4040-0019]


Agency Information Collection Request; 30-Day Public Comment 
Request

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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

SUMMARY: In compliance with the requirement of the Paperwork Reduction 
Act of 1995, the Office of the Secretary (OS), Department of Health and 
Human Services, is publishing the following summary of a proposed 
collection for public comment.

DATES: Comments on the ICR must be received on or before March 19, 
2020.

ADDRESSES: Submit your comments to [email protected] or via 
facsimile to (202) 395-5806.

FOR FURTHER INFORMATION CONTACT: Ed Calimag, [email protected] or 
(202) 690-7569. When submitting comments or requesting information, 
please include the document identifier 4040-0019-30D and project title 
for reference.

SUPPLEMENTARY INFORMATION: Interested persons are invited to send 
comments regarding this burden estimate or any other aspect of this 
collection of information, including any of the following subjects: (1) 
The necessity and utility of the proposed information collection for 
the proper performance of the agency's functions; (2) the accuracy of 
the estimated burden; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) the use of 
automated collection techniques or other forms of information 
technology to minimize the information collection burden.
    Title of the Collections: Project Abstract Summary.
    Type of Collection: Revision.
    OMB No.: 4040-0019.
    Abstract: Project Abstract Summary form provides the Federal grant-
making agencies an alternative to the Standard Form 424 data set and 
form. Project Abstract Summary programs are not required to collect all 
the data that is required on the SF-424 core data set and form. 
Grants.gov seeks revision without renewal and designation as a Common 
Form due to updates to the IC. The IC was modified to remove data 
elements. The IC was renewed with an expiration date of 02/28/2022 and 
does not require an extension.

                                        Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
                                                                     Number of        Average
                      Forms                          Number of     responses per   burden  hours   Total  burden
                                                    respondents     respondent     per  response       hours
----------------------------------------------------------------------------------------------------------------
Project Abstract Summary........................           3,467               1               1           3,467
    Total.......................................           3,467  ..............  ..............           3,467
----------------------------------------------------------------------------------------------------------------


Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the 
Secretary.
[FR Doc. 2020-03128 Filed 2-14-20; 8:45 am]
BILLING CODE 4151-AE-P