83 FR 46504 - Agency Information Collection Activities: Proposed Collection: Public Comment Request; Forms for Use With Applications to the Maternal and Child Health Bureau Research and Training Grants, OMB No. 0906-New
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 83, Issue 178 (September 13, 2018)
Health Resources and Services Administration
Federal Register Volume 83, Issue 178 (September 13, 2018)
| Page Range | 46504-46505 | |
| FR Document | 2018-19903 |
[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)] [Notices] [Pages 46504-46505] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19903] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request; Forms for Use With Applications to the Maternal and Child Health Bureau Research and Training Grants, OMB No. 0906--New AGENCY: Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: 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 must be received no later than November 13, 2018. ADDRESSES: Submit your comments to [email protected] or mail the HRSA Information Collection Clearance Officer, Room 14N136B, 5600 Fishers Lane, Rockville, MD 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 [email protected] 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 information request collection title for reference. Information Collection Request Title: Forms for Use with Applications to the Maternal and Child Health Bureau Research and Training Grants, OMB No. 0906-xxxx--New. Abstract: HRSA currently utilizes the National Institute of Health's (NIH) Biographical Sketch and Public Health Service (PHS) Inclusion Enrollment forms (0925-0001) for HRSA's SF424 Research & Related application package research grants. In order to update the forms to meet HRSA's needs, HRSA plans to remove the NIH-specific references and obtain its own OMB control number for the collection of this information. Need and Proposed Use of the Information: HRSA's Maternal and Child Health Bureau (MCHB) plans to modify the Biographical Sketch and the [[Page 46505]] PHS Inclusion Enrollment Form in slightly different ways in order to meet the needs of its own research and training grant programs. In MCHB's research grant programs, the modified Biographical Sketch form will be used by applicants to summarize the qualifications of each key personnel on their proposed research team, and grant reviewers will use this information to assess the capabilities of the research team to carry out the research project as planned. Monitoring inclusion enrollment is one important component of ensuring demographic diversity (race, ethnicity, and gender) among research study participants in MCHB's research grant portfolio. MCHB's modified PHS Inclusion Enrollment form will be used by applicants to summarize their expected population of research study participants at the time of submission of their proposal, and it will also be used for Enrollment Reporting during the annual Noncompeting Continuation Award. Likely Respondents: Respondents are applicants to MCHB's research programs. 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 personnel to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this Information Collection Request are summarized in the table below. Total Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Form name Number of responses per Total per response Total burden respondents respondent responses (in hours) hours ---------------------------------------------------------------------------------------------------------------- Biographical Sketch for MCHB 200 5 1,000 2.0 2,000 research grant applicants...... PHS Inclusion Enrollment form 200 1 200 0.5 100 for MCHB research grant applications................... ------------------------------------------------------------------------------- Total....................... 400 .............. 1,200 .............. 2,100 ---------------------------------------------------------------------------------------------------------------- HRSA specifically requests comments on: (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. Amy P. McNulty, Acting Director, Division of the Executive Secretariat. [FR Doc. 2018-19903 Filed 9-12-18; 8:45 am] BILLING CODE 4165-15-P
![46504 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Average
Number of
Number of Total annual burden per
21 CFR section and activity responses per Total hours
respondents responses response
respondent 2 (in hours)
Total Hours (§ 1107.1(c)) .............................................. ........................ ........................ ........................ ........................ 732
Section 905(j)(1)(A)(ii) of the FD&C Act: If exemption granted, report submitted to demonstrate tobacco product is modified under sec-
tion 905(j)(3), modifications are to a product that is commercially marketed and compliant, and modifications covered by exemp-
tions granted by Secretary under section 905(j)(3)
Abbreviated report submitted to demonstrate tobacco
product is modified under section 905(j)(3), modifica-
tions are to a product that is commercially marketed and
compliant, and modifications covered by exemptions
granted by Secretary under section 905(j)(3) .................. 1217 1 1217 3 3,651
Total Hours (section 905(j)(1)(A)(ii)) of the FD&C Act ........................ ........................ ........................ ........................ 3,651
Total Hours Exemptions From Substantial Equiva-
lence Requirements .................................................. ........................ ........................ ........................ ........................ 23,871
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that we will receive from Substantial Equivalence public regarding the burden estimate
812 exemption requests under Requirements will be 23,871 hours. below or any other aspect of the ICR.
§ 1107.1(b) for 24 hours per response FDA’s estimates are based on full DATES: Comments on this ICR must be
including EA for a total of 19,488 hours. analysis of economic impacts and received no later than November 13,
Since an EA is required for each information gathered from other FDA- 2018.
§ 1107.1(b) (Optional Preparation of regulated products. Based on a review of ADDRESSES: Submit your comments to
Tobacco Product Exemption From the currently approved information paperwork@hrsa.gov or mail the HRSA
Substantial Equivalence Request), the collection, we have made no Information Collection Clearance
burden per response for EAs (12 hours) adjustments to our burden estimate.
has been combined with the 12 hours Officer, Room 14N136B, 5600 Fishers
for an SE request for a total of 24 hours Dated: September 7, 2018. Lane, Rockville, MD 20857.
per response. Leslie Kux, FOR FURTHER INFORMATION CONTACT: To
FDA further estimates that we will Associate Commissioner for Policy. request more information on the
receive 244 submissions requiring [FR Doc. 2018–19913 Filed 9–12–18; 8:45 am] proposed project or to obtain a copy of
additional information in support of the BILLING CODE 4164–01–P
the data collection plans and draft
initial exemption request, and it is instruments, email paperwork@hrsa.gov
expected that it will take an average of or call Lisa Wright-Solomon, the HRSA
3 hours to prepare the additional DEPARTMENT OF HEALTH AND Information Collection Clearance Officer
information for a total of 732 hours. HUMAN SERVICES at (301) 443–1984.
FDA estimates that 1,217 respondents SUPPLEMENTARY INFORMATION: When
will prepare 1,217 responses and each Health Resources and Services submitting comments or requesting
response will take approximately 3 Administration information, please include the
hours to prepare, as required by section information request collection title for
905(j)(1)(A)(ii) of the FD&C Act, for a Agency Information Collection reference.
total of 3,651 hours. Activities: Proposed Collection: Public Information Collection Request Title:
This collection of information Comment Request; Forms for Use With Forms for Use with Applications to the
requires a manufacturer to submit a Applications to the Maternal and Child Maternal and Child Health Bureau
report at least 90 days prior to making Health Bureau Research and Training Research and Training Grants, OMB No.
an introduction or delivery for Grants, OMB No. 0906—New 0906–xxxx—New.
introduction into interstate commerce Abstract: HRSA currently utilizes the
for commercial distribution of a tobacco AGENCY: Health Resources and Services National Institute of Health’s (NIH)
product. Section 905(j)(1)(A)(ii) of the Administration (HRSA), Department of Biographical Sketch and Public Health
FD&C Act states that if an exemption Health and Human Services (HHS). Service (PHS) Inclusion Enrollment
has been requested and granted, the ACTION: Notice. forms (0925–0001) for HRSA’s SF424
manufacturer must submit to FDA a Research & Related application package
report that demonstrates that the SUMMARY: In compliance with the research grants. In order to update the
tobacco product is modified within the requirement for opportunity for public forms to meet HRSA’s needs, HRSA
meaning of section 905(j)(3), the comment on proposed data collection plans to remove the NIH-specific
daltland on DSKBBV9HB2PROD with NOTICES
modifications are to a product that is projects of the Paperwork Reduction Act references and obtain its own OMB
commercially marketed and in of 1995, HRSA announces plans to control number for the collection of this
compliance with the requirements of the submit an Information Collection information.
FD&C Act, and all the modifications are Request (ICR), described below, to the Need and Proposed Use of the
covered by exemptions granted by the Office of Management and Budget Information: HRSA’s Maternal and
Secretary under section 905(j)(3). FDA (OMB). Prior to submitting the ICR to Child Health Bureau (MCHB) plans to
estimates the total hours for exemptions OMB, HRSA seeks comments from the modify the Biographical Sketch and the
VerDate Sep<11>2014 19:20 Sep 12, 2018 Jkt 244001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\13SEN1.SGM 13SEN1](https://thefederalregister.org/doc/83_FR_46682/page/1.svg)
![Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices 46505
PHS Inclusion Enrollment Form in grant portfolio. MCHB’s modified PHS needed to review instructions; to
slightly different ways in order to meet Inclusion Enrollment form will be used develop, acquire, install, and utilize
the needs of its own research and by applicants to summarize their technology and systems for the purpose
training grant programs. In MCHB’s expected population of research study of collecting, validating, and verifying
research grant programs, the modified participants at the time of submission of information, processing and
Biographical Sketch form will be used their proposal, and it will also be used maintaining information, and disclosing
by applicants to summarize the for Enrollment Reporting during the and providing information; to train
qualifications of each key personnel on annual Noncompeting Continuation personnel to be able to respond to a
their proposed research team, and grant Award. collection of information; to search data
reviewers will use this information to Likely Respondents: Respondents are sources; to complete and review the
assess the capabilities of the research applicants to MCHB’s research collection of information; and to
team to carry out the research project as programs.
transmit or otherwise disclose the
planned. Monitoring inclusion Burden Statement: Burden in this
enrollment is one important component context means the time expended by information. The total annual burden
of ensuring demographic diversity (race, persons to generate, maintain, retain, hours estimated for this Information
ethnicity, and gender) among research disclose, or provide the information Collection Request are summarized in
study participants in MCHB’s research requested. This includes the time the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average Total
Number of responses Total burden per
Form name burden
respondents per responses response hours
respondent (in hours)
Biographical Sketch for MCHB research grant applicants .. 200 5 1,000 2.0 2,000
PHS Inclusion Enrollment form for MCHB research grant
applications ....................................................................... 200 1 200 0.5 100
Total .............................................................................. 400 ........................ 1,200 ........................ 2,100
HRSA specifically requests comments property such as patentable material, Dated: September 10, 2018.
on: (1) The necessity and utility of the and personal information concerning Melanie J. Pantoja,
proposed information collection for the individuals associated with the grant Program Analyst, Office of Federal Advisory
proper performance of the agency’s applications, the disclosure of which Committee Policy.
functions; (2) the accuracy of the would constitute a clearly unwarranted [FR Doc. 2018–19915 Filed 9–12–18; 8:45 am]
estimated burden; (3) ways to enhance invasion of personal privacy. BILLING CODE 4140–01–P
the quality, utility, and clarity of the
Name of Committee: National Institute of
information to be collected; and (4) the
General Medical Sciences Special Emphasis DEPARTMENT OF HEALTH AND
use of automated collection techniques
Panel; Review of NIGMS Support of HUMAN SERVICES
or other forms of information
Competitive Research (SCORE) Award
technology to minimize the information
Applications. National Institutes of Health
collection burden.
Date: November 14, 2018.
Amy P. McNulty, Time: 8:00 a.m. to 6:00 p.m. National Institute of General Medical
Acting Director, Division of the Executive Agenda: To review and evaluate grant Sciences; Notice of Closed Meeting
Secretariat. applications.
Place: Embassy Suites at the Chevy Chase Pursuant to section 10(d) of the
[FR Doc. 2018–19903 Filed 9–12–18; 8:45 am]
Pavilion, 4300 Military Road NW, Federal Advisory Committee Act, as
BILLING CODE 4165–15–P
Washington, DC 20015. amended, notice is hereby given of the
Contact Person: Nina Sidorova, Ph.D., following meeting.
Scientific Review Officer, Office of Scientific The meeting will be closed to the
DEPARTMENT OF HEALTH AND public in accordance with the
HUMAN SERVICES Review, National Institute of General Medical
Sciences, National Institutes of Health, 45 provisions set forth in sections
National Institutes of Health Center Drive, Room 3AN.22, Bethesda, MD 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
20892–6200, 301–594–3663, sidorova@ as amended. The grant applications and
National Institute of General Medical nigms.nih.gov. the discussions could disclose
Sciences; Notice of Closed Meeting confidential trade secrets or commercial
(Catalogue of Federal Domestic Assistance
property such as patentable material,
Pursuant to section 10(d) of the Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
and personal information concerning
Federal Advisory Committee Act, as individuals associated with the grant
amended, notice is hereby given of the Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry applications, the disclosure of which
following meeting. would constitute a clearly unwarranted
daltland on DSKBBV9HB2PROD with NOTICES
The meeting will be closed to the Research; 93.862, Genetics and
Developmental Biology Research; 93.88, invasion of personal privacy.
public in accordance with the
provisions set forth in sections Minority Access to Research Careers; 93.96, Name of Committee: NIGMS Initial Review
Special Minority Initiatives; 93.859, Group; Training and Workforce Development
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Subcommittee—C; Review of MARC/RISE
as amended. The grant applications and Biomedical Research and Research Training,
National Institutes of Health, HHS) Applications.
the discussions could disclose Date: October 29–30, 2018.
confidential trade secrets or commercial Time: 8:00 a.m. to 5:00 p.m.
VerDate Sep<11>2014 19:20 Sep 12, 2018 Jkt 244001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\13SEN1.SGM 13SEN1](https://thefederalregister.org/doc/83_FR_46682/page/2.svg)
Document Created: 2018-09-13 01:01:54
Document Modified: 2018-09-13 01:01:54
| 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. | |
| Dates | Comments on this ICR must be received no later than November 13, 2018. | |
| Contact | To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email [email protected] or call Lisa Wright- Solomon, the HRSA Information Collection Clearance Officer at (301) 443-1984. | |
| FR Citation | 83 FR 46504 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR