Providing Regulatory Submissions in Electronic Format-Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling; Draft Guidance for Industry; Availability; Correction, 32189 [2019-14362]

Download as PDF Federal Register / Vol. 84, No. 129 / Friday, July 5, 2019 / Notices 32189 ESTIMATED ANNUALIZED BURDEN HOURS—Continued Type of respondents Total ........................................... ........................................................... Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2019–14302 Filed 7–3–19; 8:45 am] Number of responses per respondent Avg. burden per response (in hours) ........................ ........................ Number of respondents Form name 1,600 Dated: July 1, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–14362 Filed 7–3–19; 8:45 am] BILLING CODE 4164–01–P BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Food and Drug Administration [Docket No. FDA–2017–D–4303] Providing Regulatory Submissions in Electronic Format—Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling; Draft Guidance for Industry; Availability; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. Lisa Granger, Office of Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993–0002, 301–796–9115. FOR FURTHER INFORMATION CONTACT: In the Federal Register of Tuesday, September 5, 2017 (82 FR 41968), in FR Doc. 2017– 18506, the following correction is made: On page 41968, in the first column, in the header of the document, and in the second column, under Instructions, ‘‘[Docket No. FDA–2017–E–4282]’’ is corrected to read ‘‘[Docket No. FDA– 2017–D–4303].’’ jbell on DSK3GLQ082PROD with NOTICES SUPPLEMENTARY INFORMATION: 17:54 Jul 03, 2019 Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this ICR should be received no later than September 3, 2019. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 14N136B, 5600 Fishers Lane, Rockville, Maryland 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at (301) 443–1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the ICR title for reference. Information Collection Request Title: Nurse Anesthetist Traineeship (NAT) SUMMARY: The Food and Drug Administration is correcting a notice entitled ‘‘Providing Regulatory Submissions in Electronic Format— Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling; Draft Guidance for Industry; Availability’’ that appeared in the Federal Register of September 5, 2017. The document announced the availability of a guidance for industry. The document was published with the incorrect docket number. This document corrects that error. Previously submitted comments will be transferred to the correct docket number. SUMMARY: VerDate Sep<11>2014 Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Nurse Anesthetist Traineeship Program Specific Data Forms, OMB No. 0915– 0374—Revision Jkt 247001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 Total burden (in hours) 1,253 Program Specific Data Forms (Application), OMB Number 0915– 0374—Revision. Abstract: HRSA provides advanced education nursing training grants to educational institutions to increase the numbers of Nurse Anesthetists through the NAT Program. NAT Program is authorized by Section 811 of the Public Health Service (PHS) Act (42 U.S.C. 296j). The NAT Tables request information on program participants such as the total number of enrollees, number of enrollees/trainees supported, total number of graduates, number of graduates supported, projected data on the number of enrollees/trainees, and the distribution of Nurse Anesthetists who practice in underserved, rural, or public health practice settings. Need and Proposed Use of the Information: Funds appropriated for the NAT Program are distributed among eligible institutions based on a formula, as permitted by PHS Act section 806(e)(1). HRSA uses the data from the NAT Tables to: (1) Determine whether funding preferences or special considerations are met; (2) calculate award amounts; ensure compliance with programmatic and grant requirements; and (3) provide information to the public and Congress. NAT Tables currently collect one year of data, which allows HRSA to calculate award amounts for a single-year project period. For fiscal year 2020, HRSA is revising the forms that previously collected one year of data on prospective students to capture three years of data, thereby allowing HRSA to calculate award amounts for a multi-year project period. Table 1 will add an option to add year 2 and year 3 data for the number of prospective students. Table 2 will not be changed. Likely Respondents: Respondents will be applicants to HRSA’s NAT program. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose, or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; to train E:\FR\FM\05JYN1.SGM 05JYN1

Agencies

[Federal Register Volume 84, Number 129 (Friday, July 5, 2019)]
[Notices]
[Page 32189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14362]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-4303]


Providing Regulatory Submissions in Electronic Format--Content of 
the Risk Evaluation and Mitigation Strategies Document Using Structured 
Product Labeling; Draft Guidance for Industry; Availability; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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

SUMMARY: The Food and Drug Administration is correcting a notice 
entitled ``Providing Regulatory Submissions in Electronic Format--
Content of the Risk Evaluation and Mitigation Strategies Document Using 
Structured Product Labeling; Draft Guidance for Industry; 
Availability'' that appeared in the Federal Register of September 5, 
2017. The document announced the availability of a guidance for 
industry. The document was published with the incorrect docket number. 
This document corrects that error. Previously submitted comments will 
be transferred to the correct docket number.

FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, 
Silver Spring, MD 20993-0002, 301-796-9115.

SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday, 
September 5, 2017 (82 FR 41968), in FR Doc. 2017-18506, the following 
correction is made:
    On page 41968, in the first column, in the header of the document, 
and in the second column, under Instructions, ``[Docket No. FDA-2017-E-
4282]'' is corrected to read ``[Docket No. FDA-2017-D-4303].''

    Dated: July 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14362 Filed 7-3-19; 8:45 am]
BILLING CODE 4164-01-P

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