Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices 7619 

Recognized Standards, Recognition List 

Number: 039’’ will be available http://

www.fda.gov/MedicalDevices/Device

RegulationandGuidance/Standards/

ucm123792.htm. 

You may access ‘‘Guidance on the 

Recognition and Use of Consensus 

Standards,’’ and the searchable database 

for ‘‘FDA Recognized Consensus 

Standards’’ at http://www.fda.gov/

MedicalDevices/DeviceRegulationand

Guidance/Standards. 

VI. Submission of Comments and 

Effective Date 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. FDA will consider 

any comments received in determining 

whether to amend the current listing of 

modifications to the list of recognized 

standards, Recognition List Number: 

039. These modifications to the list of 

recognized standards are effective upon 

publication of this notice in the Federal 

Register. 

Dated: February 5, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–02801 Filed 2–10–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60-Day Comment 

Request; Population Assessment of 

Tobacco and Health (PATH) Study 

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 

National Institute on Drug Abuse 

(NIDA), 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) 

The quality, utility, and clarity of the 

information to be collected; and (4) The 

approaches used 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: Kevin P. Conway, 

Ph.D., Deputy Director, Division of 

Epidemiology, Services, and Prevention 

Research, National Institute on Drug 

Abuse, 6001 Executive Boulevard, Room 

5185; or call non-toll-free number (301)– 

443–8755; or Email your request, 

including your address to: 

PATHprojectofficer@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: Population 

Assessment of Tobacco and Health 

(PATH) Study—Third Wave of Data 

Collection—0925–0664–REVISION— 

National Institutes of Health (NIH), 

National Institute on Drug Abuse 

(NIDA), in partnership with the Food 

and Drug Administration (FDA). 

Need and Use of Information 

Collection: This is a revision request 

(OMB 0925–0664, Exp. Date 9/30/2016) 

for the Population Assessment of 

Tobacco and Health (PATH) Study to 

conduct the third wave of data 

collection. The PATH Study is a large 

national longitudinal cohort study on 

tobacco use behavior and health among 

the U.S. household population of adults 

age 18 and older and youth ages 12 to 

17. The PATH Study conducts annual 

interviews and collects biospecimens 

from adults to help inform the 

development, implementation, and 

evaluation of tobacco-product 

regulations by FDA in meeting its 

mission under the Family Smoking 

Prevention and Tobacco Control Act 

(TCA) to regulate tobacco products, 

including tobacco-product advertising, 

labeling, marketing, constituents, 

ingredients, and additives. The 

longitudinal design of the PATH Study 

provides it with the capacity to measure 

and report within-person changes and 

between-person differences in tobacco 

product use behaviors and health effects 

within the cohort over time. These data 

will help to inform regulatory decisions 

and actions by FDA and FDA’s 

evaluations of associations between its 

regulations and tobacco use behaviors 

and health indicators in the population. 

OMB approval is requested for 3 

years. There are no capital, operating, or 

maintenance costs to report. There are 

no costs to respondents other than their 

time. The total estimated annualized 

burden hours are 53,459. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent and instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

per response 

(in hours) 

Total annual 

burden hours 

Adults—Adult respondents at Wave 1 or Wave 2—Extended 

Interview ....................................................................................... 25,692 1 1 25,692 

Adults—Wave 1 youth respondents who age up to adult cohort at 

Wave 3—Consent for Extended Interview ................................... 2,317 1 4/60 154 

Adults—Wave 1 youth respondents who age up to adult cohort at 

Wave 3—Extended Interview ....................................................... 1,738 1 68/60 1,970 

Adults—Wave 1 youth respondents who age up to adult cohort at 

Wave 3—Consent for Biological Samples ................................... 1,738 1 5/60 145 

Adults—Biospecimen Collection: Urine ........................................... 13,703 1 10/60 2,284 


tkelley on DSK3SPTVN1PROD with NOTICES
7620 Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondent and instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

per response 

(in hours) 

Total annual 

burden hours 

Adults—Biospecimen Collection: Blood .......................................... 869 1 18/60 261 

Adults—Tobacco Use Form ............................................................ 14,572 1 4/60 971 

Adults—Follow-up/Tracking Participant Information Form .............. 27,430 2 8/60 7,315 

Youth—Youth respondents at Wave 1 or Wave 2—Extended 

Interview ....................................................................................... 9,515 1 32/60 5,075 

Youth—Shadow youth who age up to youth cohort at Wave 3— 

Assent for Extended Interview ..................................................... 2,420 1 3/60 121 

Youth—Shadow youth who age up to youth cohort at Wave 3— 

Extended Interview ....................................................................... 1,912 1 42/60 1,338 

Adult—Youth respondents at Wave 1 or Wave 2—Parent Interview .............................................................................................. 9,705 1 14/60 2,265 

Adults—Parents of Shadow youth who age up to youth cohort at 

Wave 3—Parent Permission and Consent for Parent Interview 2,420 1 5/60 202 

Adults—Parents of Shadow youth who age up to youth cohort at 

Wave 3—Parent Interview ........................................................... 1,950 1 17/60 553 

Adults—Verification Interview .......................................................... 35,564 1 2/60 1,185 

Adults—Validation Interview ............................................................ 3,613 1 4/60 241 

Adults—Follow-up/Tracking Participant Information Form for 

Youth (completed by parents) ...................................................... 11,427 2 8/60 3,047 

Adults—Follow-up/Tracking Participant Information Form for sample Shadow youth (completed by parents) .................................. 2,401 2 8/60 640 

Dated: February 5, 2015. 

Genevieve deAlmeida-Morris, 

Project Clearance Liaison, National Institute 

on Drug Abuse, NIH. 

[FR Doc. 2015–02832 Filed 2–10–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Arthritis and 

Musculoskeletal and Skin Diseases; 

Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), 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 

Arthritis and Musculoskeletal and Skin 

Diseases Special Emphasis Panel; NIAMS 

Clinical Study Applications. 

Date: March 20, 2015. 

Time: 8:00 a.m. to 3:30 p.m. 

Agenda: To review and evaluate grant 

applications 

Place: National Institutes of Health, One 

Democracy Plaza, Suite 800, 6701 Democracy 

Boulevard, Bethesda, MD 20892. 

Contact Person: Kan Ma, Ph.D., Scientific 

Review Officer, Scientific Review Branch 

National Institute of Arthritis, 

Musculoskeletal and Skin Diseases, NIH, 

6701 Democracy Boulevard, Suite 814, 

Bethesda, MD 20892, 301–451–4838 mak2@

mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.846, Arthritis, 

Musculoskeletal and Skin Diseases Research, 

National Institutes of Health, HHS) 

Dated: February 5, 2015. 

Carolyn Baum, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–02758 Filed 2–10–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Amended Notice 

of Meeting 

Notice is hereby given of a change in 

the meeting of the National Institute of 

Neurological Disorders and Stroke 

Special Emphasis Panel, March 16, 

2015, 08:00 a.m. to March 17, 2015, 

06:00 p.m., Bethesda North Marriott 

Hotel & Conference Center, Montgomery 

County Conference Center Facility, 5701 

Marinelli Road, North Bethesda, MD 

20852 which was published in the 

Federal Register on January 23, 2015, 

80FRN3613. 

The meeting has been changed to a 

teleconference meeting. The date and 

time remain the same. The meeting is 

closed to the public. 

Dated: February 5, 2015. 

Carolyn Baum, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–02757 Filed 2–10–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), 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: Microbiology, 

Infectious Diseases and AIDS Initial Review 

Group; Microbiology and Infectious Diseases 

B Subcommittee. 


tkelley on DSK3SPTVN1PROD with NOTICES