46504 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

21 CFR section and activity Number of 

respondents 

Number of 

responses per 

respondent 2

Total annual 

responses 

Average 

burden per 

response 

(in hours) 

Total 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 section 905(j)(3), modifications are to a product that is commercially marketed and compliant, and modifications covered by exemptions granted by Secretary under section 905(j)(3) 

Abbreviated report submitted to demonstrate tobacco 

product is modified under section 905(j)(3), modifications 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 Equivalence Requirements .................................................. ........................ ........................ ........................ ........................ 23,871 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

FDA estimates that we will receive 

812 exemption requests under 

§ 1107.1(b) for 24 hours per response 

including EA for a total of 19,488 hours. 

Since an EA is required for each 

§ 1107.1(b) (Optional Preparation of 

Tobacco Product Exemption From 

Substantial Equivalence Request), the 

burden per response for EAs (12 hours) 

has been combined with the 12 hours 

for an SE request for a total of 24 hours 

per response. 

FDA further estimates that we will 

receive 244 submissions requiring 

additional information in support of the 

initial exemption request, and it is 

expected that it will take an average of 

3 hours to prepare the additional 

information for a total of 732 hours. 

FDA estimates that 1,217 respondents 

will prepare 1,217 responses and each 

response will take approximately 3 

hours to prepare, as required by section 

905(j)(1)(A)(ii) of the FD&C Act, for a 

total of 3,651 hours. 

This collection of information 

requires a manufacturer to submit a 

report at least 90 days prior to making 

an introduction or delivery for 

introduction into interstate commerce 

for commercial distribution of a tobacco 

product. Section 905(j)(1)(A)(ii) of the 

FD&C Act states that if an exemption 

has been requested and granted, the 

manufacturer must submit to FDA a 

report that demonstrates that the 

tobacco product is modified within the 

meaning of section 905(j)(3), the 

modifications are to a product that is 

commercially marketed and in 

compliance with the requirements of the 

FD&C Act, and all the modifications are 

covered by exemptions granted by the 

Secretary under section 905(j)(3). FDA 

estimates the total hours for exemptions 

from Substantial Equivalence 

Requirements will be 23,871 hours. 

FDA’s estimates are based on full 

analysis of economic impacts and 

information gathered from other FDAregulated products. Based on a review of 

the currently approved information 

collection, we have made no 

adjustments to our burden estimate. 

Dated: September 7, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19913 Filed 9–12–18; 8:45 am] 

BILLING CODE 4164–01–P 

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 

paperwork@hrsa.gov 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 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 

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 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices 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

Form name Number of 

respondents 

Number of 

responses 

per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total 

burden 

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 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

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 Institute of 

General Medical Sciences Special Emphasis 

Panel; Review of NIGMS Support of 

Competitive Research (SCORE) Award 

Applications. 

Date: November 14, 2018. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy Chase 

Pavilion, 4300 Military Road NW, 

Washington, DC 20015. 

Contact Person: Nina Sidorova, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review, National Institute of General Medical 

Sciences, National Institutes of Health, 45 

Center Drive, Room 3AN.22, Bethesda, MD 

20892–6200, 301–594–3663, sidorova@

nigms.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.375, Minority Biomedical 

Research Support; 93.821, Cell Biology and 

Biophysics Research; 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.862, Genetics and 

Developmental Biology Research; 93.88, 

Minority Access to Research Careers; 93.96, 

Special Minority Initiatives; 93.859, 

Biomedical Research and Research Training, 

National Institutes of Health, HHS) 

Dated: September 10, 2018. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–19915 Filed 9–12–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

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: NIGMS Initial Review 

Group; Training and Workforce Development 

Subcommittee—C; Review of MARC/RISE 

Applications. 

Date: October 29–30, 2018. 

Time: 8:00 a.m. to 5:00 p.m. 


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