78452 Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices 

and pharmacodynamics of nicotine 

exposure in users; (4) abuse liability and 

dependence; (5) short and long-term 

health effects in users; (6) 

considerations for high risk or 

vulnerable populations; and (7) human 

factors. Additional information related 

to workshop presentations and 

discussion topics, including specific 

questions to be addressed at the 

workshop, can be found at http://

www.fda.gov/TobaccoProducts/

NewsEvents/ucm238308.htm. 

Dated: December 22, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30450 Filed 12–29–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60-Day Comment 

Request; Responsibility of Applicants 

for Promoting Objectivity in Research 

for Which Public Health Service (PHS) 

Funding Is Sought 42 CFR Part 50 

Subpart F and Responsible 

Prospective Contractors 45 CFR Part 

94 (OD) 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

Office of the Director (OD), National 

Institutes of Health (NIH), will publish 

periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Written comments and/or suggestions 

from the public and affected agencies 

are invited on one or more of the 

following points: (1) Whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) The accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; (3) 

Ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Ways to minimize the 

burden of the collection of information 

on those who are to respond, including 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

To submit comments and for further 

information: To obtain a copy of the 

data collection plans and instruments, 

submit comments in writing, or request 

more information on the proposed 

project, contact: Ms. Kathy Hancock, 

Assistant Grants Compliance Officer, 

Division of Grants Compliance and 

Oversight, Office of Policy for 

Extramural Research Administration 

(OPERA), 6705 Rockledge Drive, Room 

3523, Bethesda, MD 20892, or call nontoll-free number (301) 435–1962, or 

Email your request, including your 

address to: FCOICompliance@

mail.nih.gov. Formal requests for 

additional plans and instruments must 

be requested in writing. 

DATES: Comment Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Proposed Collection: Title: 

Responsibility of Applicants for 

Promoting Objectivity in Research for 

which Public Health Service (PHS) 

Funding is Sought 42 CFR part 50 

Subpart F and Responsible Prospective 

Contractors 45 CFR part 94 OMB# 0925– 

0417, Expiration Date: 02/2015, 

EXTENSION, National Institutes of 

Health (NIH), Office of the Director 

(OD). 

Need and Use of Information 

Collection: This is a request for OMB 

Approval for an extension of the 

information collection and 

recordkeeping requirements contained 

in the final rule 42 CFR part 50, subpart 

F and 45 CFR part 94. The purpose of 

these regulations is to promote 

objectivity in research by requiring 

institutions to establish standards that 

provide a reasonable expectation that 

the design, conduct, and reporting of 

research funded under PHS grants, 

cooperative agreements and contracts 

will be free from bias resulting from 

Investigator financial conflicts of 

interest. 

OMB approval is requested for an 

extension of 3 years. There are operating 

costs and/or maintenance costs per 

response. The total estimated 

annualized burden hours are 676,130. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent based on applicable section of regulation Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total annual 

burden hour 

Reporting 

Initial Reports under 42 CFR 50.605(b)(1) and (b)(3) or 45 CFR 94.5(b)(1) 

and (b)(3) from Awardee Institutions ........................................................... 950 1 2 1,900 

Subsequent Reports under 42 CFR 50.605(a)(3)(iii) and (b)(2) or 45 CFR 

94.5(a)(iii) and (b)(2) from Awardee Institutions .......................................... 50 1 2 100 

Mitigation Reports under 45 CFR 94.5(a)(3)(iii) and (b)(2) from Awardee Institutions ....................................................................................................... 5 1 2 10 

Annual Report under 42 CFR 50.605(b)(4) or 45 CFR 94.5(b)(4) from 

Awardee Institution ....................................................................................... 950 1 1 950 

Subsequent Reports under 42 CFR 60.606(a) or 45 CFR 94.6(a) from 

Awardee Institution ....................................................................................... 20 1 10 200 

Record Keeping 

Under 42 CFR 50.604(i) or 45 CFR 94.4(i) from Awardee Institutions .......... 2,000 1 4 8,000 

Disclosure 

Under 42 CFR 50.604(a) or 45 CFR 94.4(a) for Investigators ....................... 3,000 1 81 243,000 

Under 42 CFR 50.604(b) or 45 CFR 94.4(b) for Investigators ....................... 38,000 1 30/60 19,000 

Under 42 CFR 50.604(b) or 45 CFR 94.4(b) for Institutions .......................... 2,000 1 6 12,000 

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Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices 78453 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondent based on applicable section of regulation Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total annual 

burden hour 

Under 42 CFR 50.604(c)(1) or 45 CFR 94(c)(1) from Sub-recipients ............ 500 1 1 500 

Under 42 CFR 50.604(d) or 45 CFR 94.4(d) Institutions ................................ 3,000 1 1 3,000 

Under 42 CFR 50.604(e)(1) or 45 CFR 94.4(e)(1) for Investigators .............. 38,000 1 4 152,000 

Under 42 CFR 50.604(e)(2) or 45 CFR 94.4(e)(2) for Investigators .............. 38,000 1 1 38,000 

Under 42 CFR 50.604(e)(3) or 45 CFR 94.4(e)(3) for Investigators .............. 950 1 30/60 475 

Under 42 CFR 50.604(f) or 45 CFR 94.4(f) for Institutions ............................ 2,000 1 1 2,000 

Under 42 CFR 50.605(a)(1) or 45 CFR 94.5(a)(1) for Institutions .................. 2,000 1 82 164,000 

Under 42 CFR 50.605(a)(3) or 45 CFR 94.5(a)(3) for Institutions .................. 500 1 3 1,500 

Under 42 CFR 50.605(a)(3)(i) or 45 CFR 94.5(a)(3)(i) for Institutions ........... 50 1 80 4,000 

Under 42 CFR 50.605(a)(3)(ii) or 45 CFR 94.5(a)(3)(ii) for Institutions .......... 50 1 80 4,000 

Under 42 CFR 50.605(a)(3)(iii) or 45 CFR 94.5(a)(3)(iii) for Institutions ........ 50 1 1 50 

Under 42 CFR 50.605(a)(4) or 45 CFR 94.5(a)(4) for Institutions .................. 950 1 12 11,400 

Under 42 CFR 50.605(a)(5) or 45 CFR 94.5(a)(5) for Institutions .................. 2,000 1 5 10,000 

Under 42 CFR 50.606(c) or 45 CFR 94.6(c) for Institutions ........................... 50 1 30/60 45 

Dated: December 17, 2014. 

Lawrence Tabak, 

Deputy Director, Office of the Director, NIH. 

[FR Doc. 2014–30355 Filed 12–29–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60-Day Comment 

Request; Generic Clearance for the 

Collection of Qualitative Feedback on 

Agency Service Delivery (NINR) 

SUMMARY: As part of a Federal 

Government-wide effort to streamline 

the process to seek feedback from the 

public on service delivery, the National 

Institute of Nursing Research has 

submitted a Generic Information 

Collection Request (Generic ICR): 

‘‘Generic Clearance for the Collection of 

Qualitative Feedback on Agency Service 

Delivery’’ to OMB for approval under 

the Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.). This notice 

announces our intent to submit this 

collection to OMB for approval and 

solicits comments on specific aspects 

for the proposed information collection. 

To Submit Comments and for Further 

Information: To obtain a copy of the 

data collection plans and instruments, 

submit comments in writing, or request 

more information on the proposed 

project, contact: Dr. Rebecca Hawes, 

Division of Science Policy and Public 

Liaison, NINR, NIH, Democracy One, 

6701 Democracy Blvd., Suite 710, 

Bethesda, MD 20892, by phone at (301) 

594–0791 or email your request, 

including your address to: hawesr@

mail.nih.gov. Formal requests for 

additional plans and instruments must 

be requested in writing. 

Comment Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Proposed Collection: Generic 

Clearance for the Collection of 

Qualitative Feedback on Agency Service 

Delivery, 0925–0653, Expiration Date 

3/31/2015, EXTENSION, National 

Institutes of Health (NIH), National 

Institute of Nursing Research (NINR). 

Need and Use of Information 

Collection: There are no changes being 

requested for this submission. The 

information collection activity will 

continue to garner qualitative customer 

and stakeholder feedback in an efficient, 

timely manner, in accordance with the 

Administration’s commitment to 

improving service delivery. By 

qualitative feedback we mean 

information that provides useful 

insights on perceptions and opinions, 

but are not statistical surveys that yield 

quantitative results that can be 

generalized to the population of study. 

This feedback will provide insights into 

customer or stakeholder perceptions, 

experiences and expectations, provide 

an early warning of issues with service, 

or focus attention on areas where 

communication, training or changes in 

operations might improve delivery of 

products or services. These collections 

will allow for ongoing, collaborative and 

actionable communications between the 

Agency and its customers and 

stakeholders. It will also allow feedback 

to contribute directly to the 

improvement of program management. 

Improving agency programs requires 

ongoing assessment of service delivery, 

by which we mean systematic review of 

the operation of a program compared to 

a set of explicit or implicit standards, as 

a means of contributing to the 

continuous improvement of the 

program. The Agency will collect, 

analyze, and interpret information 

gathered through this generic clearance 

to identify strengths and weaknesses of 

current services and make 

improvements in service delivery based 

on feedback. The solicitation of 

feedback will target areas such as: 

Timeliness, appropriateness, accuracy 

of information, courtesy, efficiency of 

service delivery, and resolution of 

issues with service delivery. Responses 

will be assessed to plan and inform 

efforts to improve or maintain the 

quality of service offered to the public. 

If this information is not collected, vital 

feedback from customers and 

stakeholders on the Agency’s services 

will be unavailable. 

NINR will only submit a collection for 

approval under this generic clearance if 

it meets the following conditions: 

• The collections are voluntary; 

• The collections are low-burden for 

respondents (based on considerations of 

total burden hours, total number of 

respondents, or burden-hours per 

respondent) and are low-cost for both 

the respondents and the Federal 

Government; 

• The collections are noncontroversial and do not raise issues of 

concern to other Federal agencies; 

• Any collection is targeted to the 

solicitation of opinions from 

respondents who have experience with 

the program or may have experience 

with the program in the near future; 

• Personally identifiable information 

(PII) is collected only to the extent 

necessary and is not retained; 

• Information gathered will be used 

only internally for general service 

improvement and program management 

purposes and is not intended for release 

outside of the agency; 

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