80 FR 34684 - Submission for OMB Review; 30-Day Comment Request; Population Assessment of Tobacco and Health (PATH) Study-3rd Wave (NIDA)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 116 (June 17, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 116 (June 17, 2015)
| Page Range | 34684-34685 | |
| FR Document | 2015-14902 |
[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)] [Notices] [Pages 34684-34685] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-14902] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; Population Assessment of Tobacco and Health (PATH) Study--3rd Wave (NIDA) SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on February 11, 2015, pages 7619-7620 and allowed 60-days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute on Drug Abuse (NIDA), National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, [email protected] or by fax to (202) 395-6974, Attention: NIH Desk Officer. DATES: Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments or request more information on the proposed project, contact: Dr. Kevin P. Conway, Deputy Director, Division of Epidemiology, Services, and Prevention Research, NIDA, NIH, 6001 Executive Boulevard, Room 5185, Rockville, MD 20852; or call non- toll-free number (301) 443-8755 or Email your request, including your address to: [email protected]. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Population Assessment of Tobacco and Health (PATH) Study--Third Wave of Data Collection--0925-0664--Revision, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), in partnership with the Food and Drug Administration (FDA). Need and Use of Information Collection: This is a revision request (OMB 0925-0664, expires 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 national longitudinal cohort study of tobacco use behavior and health among the U.S. household population of adults age 18 and older and youth ages 12 to 17. The Study conducts annual interviews and collects biospecimens from adults to assess within-person changes and between-person differences in tobacco-product use behaviors and related health conditions over time. Its longitudinal, population-based data will help to enhance the evidence base that informs FDA's regulatory actions under the Family Smoking Prevention and Control Act to protect the Nation's public health and reduce its burden of tobacco-related morbidity and mortality. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 54,434. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Form or activity name Type of Number of responses per per response Total annual respondent respondents respondent (in hours) burden hours ---------------------------------------------------------------------------------------------------------------- Adult Extended Interview..... Adults........... 25,444 1 1 25,444 Consent for Adult Extended Adults........... 2,046 1 4/60 136 Interview. [[Page 34685]] Adult Extended Interview Adults........... 1,780 1 68/60 2,017 (Aged-up). Consent for Biological Adults........... 1,780 1 5/60 148 Samples. Biospecimen Collection: Urine Adults........... 13,805 1 10/60 2,301 Biospecimen Collection: Blood Adults........... 765 1 18/60 230 Tobacco Use Form............. Adults........... 14,570 1 5/60 1,214 Follow-up/Tracking Adults........... 27,224 2 8/60 7,260 Participant Information Form for Adults. Youth Extended Interview..... Youth............ 9,625 1 35/60 5,615 Assent for Youth Extended Youth............ 1,923 1 3/60 96 Interview. Youth Extended Interview Youth............ 1,923 1 45/60 1,442 (Aged-up). Parent Interview............. Parents.......... 9,818 1 16/60 2,618 Parent Permission and Consent Parents.......... 2,161 1 5/60 180 for Parent Interview. Parent Interview (Aged-up)... Parents.......... 1,961 1 19/60 621 Verification Interview....... Adults........... 35,564 1 2/60 1,185 Validation Interview......... Adults........... 3,579 1 4/60 239 Follow-up/Tracking Parents.......... 11,548 2 8/60 3,079 Participant Information Form for Youth. Follow-up/Tracking Parents.......... 2,282 2 8/60 609 Participant Information Form for Sample Shadow Youth. ---------------------------------------------------------------------------------------------------------------- Dated: June 12, 2015. Genevieve deAlmeida-Morris, Project Clearance Liaison, NIDA, NIH. [FR Doc. 2015-14902 Filed 6-16-15; 8:45 am] BILLING CODE 4140-01-P
![34684 Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices
long term sustainability of the Title X resources to Title X centers. Data will be Title X Family Planning Program
network. collected through an online data [‘‘Population Research and Voluntary
Data collected from this effort will be collection tool directly from grantees Family Planning Programs’’ (91)], which
used to inform the work of the training and from Title X centers. was enacted in 1970 as Title X of the
centers so they can better support the Likely Respondents: This annual Public Health Service Act (Section 1001
Title X grantees. This data will help reporting requirement is service sites of Title X of the Public Health Service
OPA better understand challenges that receive funding (either directly Act, 42 United States Code [U.S.C.]
affecting Title X centers in order to from OPA or through a sub recipient or 300).
better work with HHS entities and grantee agency) for family planning
national stakeholders to provide services authorized and funded by the
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Average
Number of annualized Annual
Number of
Type of respondent Form name responses per burden per total burden
respondents respondent response (hours)
(hours)
Grantees ........................ Sustainability Assessment—Grantees ................ 92 1 0.66 60.72
Service Sites .................. Sustainability Assessment—Sites ....................... 4,168 1 0.66 2750.88
Total ........................ .............................................................................. 4,260 ........................ ........................ 2,811.60
Terry S. Clark, extended, revised, or implemented on or (PATH) Study—Third Wave of Data
Asst Information Collection Clearance after October 1, 1995, unless it displays Collection—0925–0664—Revision,
Officer. a currently valid OMB control number. National Institute on Drug Abuse
[FR Doc. 2015–14850 Filed 6–16–15; 8:45 am] Direct Comments to OMB: Written (NIDA), National Institutes of Health
BILLING CODE 4150–48–P comments and/or suggestions regarding (NIH), in partnership with the Food and
the item(s) contained in this notice, Drug Administration (FDA).
especially regarding the estimated Need and Use of Information
DEPARTMENT OF HEALTH AND public burden and associated response Collection: This is a revision request
HUMAN SERVICES time, should be directed to the: Office (OMB 0925–0664, expires 9/30/2016)
of Management and Budget, Office of for the Population Assessment of
National Institutes of Health Regulatory Affairs, OIRA_Submission@ Tobacco and Health (PATH) Study to
Submission for OMB Review; 30-Day omb.eop.gov or by fax to (202) 395– conduct the third wave of data
Comment Request; Population 6974, Attention: NIH Desk Officer. collection. The PATH Study is a
Assessment of Tobacco and Health DATES: Comment Due Date: Comments national longitudinal cohort study of
(PATH) Study—3rd Wave (NIDA) regarding this information collection are tobacco use behavior and health among
best assured of having their full effect if the U.S. household population of adults
SUMMARY: Under the provisions of
received within 30 days of the date of age 18 and older and youth ages 12 to
Section 3507(a)(1)(D) of the Paperwork
this publication. 17. The Study conducts annual
Reduction Act of 1995, the National
FOR FURTHER INFORMATION CONTACT: To interviews and collects biospecimens
Institutes of Health (NIH) has submitted
obtain a copy of the data collection from adults to assess within-person
to the Office of Management and Budget
plans and instruments or request more changes and between-person differences
(OMB) a request for review and
information on the proposed project, in tobacco-product use behaviors and
approval of the information collection
listed below. This proposed information contact: Dr. Kevin P. Conway, Deputy related health conditions over time. Its
collection was previously published in Director, Division of Epidemiology, longitudinal, population-based data will
the Federal Register on February 11, Services, and Prevention Research, help to enhance the evidence base that
2015, pages 7619–7620 and allowed 60- NIDA, NIH, 6001 Executive Boulevard, informs FDA’s regulatory actions under
days for public comment. One public Room 5185, Rockville, MD 20852; or the Family Smoking Prevention and
comment was received. The purpose of call non-toll-free number (301) 443– Control Act to protect the Nation’s
this notice is to allow an additional 30 8755 or Email your request, including public health and reduce its burden of
days for public comment. The National your address to: PATHprojectofficer@ tobacco-related morbidity and mortality.
Institute on Drug Abuse (NIDA), mail.nih.gov. Formal requests for OMB approval is requested for 3
National Institutes of Health may not additional plans and instruments must years. There are no costs to respondents
conduct or sponsor, and the respondent be requested in writing. other than their time. The total
is not required to respond to, an Proposed Collection: Population estimated annualized burden hours are
information collection that has been Assessment of Tobacco and Health 54,434.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Type of Number of burden per Total annual
Form or activity name responses per
respondent respondents response burden hours
respondent (in hours)
Adult Extended Interview ....................................................... Adults .......... 25,444 1 1 25,444
Consent for Adult Extended Interview ................................... Adults .......... 2,046 1 4/60 136
VerDate Sep<11>2014 18:47 Jun 16, 2015 Jkt 235001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\17JNN1.SGM 17JNN1](https://thefederalregister.org/doc/80_FR_34800/page/1.svg)
![Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices 34685
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
Number of
Type of Number of burden per Total annual
Form or activity name responses per
respondent respondents response burden hours
respondent (in hours)
Adult Extended Interview (Aged-up) ...................................... Adults .......... 1,780 1 68/60 2,017
Consent for Biological Samples ............................................. Adults .......... 1,780 1 5/60 148
Biospecimen Collection: Urine ............................................... Adults .......... 13,805 1 10/60 2,301
Biospecimen Collection: Blood ............................................... Adults .......... 765 1 18/60 230
Tobacco Use Form ................................................................. Adults .......... 14,570 1 5/60 1,214
Follow-up/Tracking Participant Information Form for Adults .. Adults .......... 27,224 2 8/60 7,260
Youth Extended Interview ...................................................... Youth ........... 9,625 1 35/60 5,615
Assent for Youth Extended Interview ..................................... Youth ........... 1,923 1 3/60 96
Youth Extended Interview (Aged-up) ..................................... Youth ........... 1,923 1 45/60 1,442
Parent Interview ..................................................................... Parents ........ 9,818 1 16/60 2,618
Parent Permission and Consent for Parent Interview ........... Parents ........ 2,161 1 5/60 180
Parent Interview (Aged-up) .................................................... Parents ........ 1,961 1 19/60 621
Verification Interview .............................................................. Adults .......... 35,564 1 2/60 1,185
Validation Interview ................................................................ Adults .......... 3,579 1 4/60 239
Follow-up/Tracking Participant Information Form for Youth .. Parents ........ 11,548 2 8/60 3,079
Follow-up/Tracking Participant Information Form for Sample Parents ........ 2,282 2 8/60 609
Shadow Youth.
Dated: June 12, 2015. Health, 6701 Rockledge Drive, Room 5217A, Place: National Institutes of Health, 6701
Genevieve deAlmeida-Morris, MSC 7846, Bethesda, MD 20892, 301–408– Rockledge Drive, Bethesda, MD 20892
Project Clearance Liaison, NIDA, NIH. 9115, bsokolov@csr.nih.gov. (Virtual Meeting).
This notice is being published less than 15 Contact Person: Ai-Ping Zou, MD, Ph.D.,
[FR Doc. 2015–14902 Filed 6–16–15; 8:45 am]
days prior to the meeting due to the timing Scientific Review Officer, Center for
BILLING CODE 4140–01–P limitations imposed by the review and Scientific Review, National Institutes of
funding cycle. Health, 6701 Rockledge Drive, Room 4118,
Name of Committee: Center for Scientific MSC 7814, Bethesda, MD 20892, 301–408–
DEPARTMENT OF HEALTH AND 9497, zouai@csr.nih.gov.
Review Special Emphasis Panel Small
HUMAN SERVICES Business: Non HIV Microbial Vaccines and Name of Committee: Center for Scientific
Countermeasures. Review Special Emphasis Panel Fellowships:
National Institutes of Health
Date: July 13–14, 2015. Oncology.
Center for Scientific Review; Notice of Time: 8:00 a.m. to 5:00 p.m. Date: July 20–21, 2015.
Agenda: To review and evaluate grant Time: 8:00 a.m. to 5:00 p.m.
Closed Meetings
applications. Agenda: To review and evaluate grant
Pursuant to section 10(d) of the Place: Wyndham Grand Chicago applications.
Federal Advisory Committee Act, as Riverfront, 71 E. Wacker Drive, Chicago, IL Place: Embassy Suites at the Chevy Chase
amended (5 U.S.C. App.), notice is 60601375. Pavilion, 4300 Military Road NW.,
Contact Person: Andrea Keane-Myers, BS, Washington, DC 20015.
hereby given of the following meetings.
Ph.D., Scientific Review Officer, Center for Contact Person: Juraj Bies, Ph.D., Scientific
The meetings will be closed to the Scientific Review, National Institutes of Review Officer, Center for Scientific Review,
public in accordance with the Health, 6701 Rockledge Drive, Room 4218, National Institutes of Health, 6701 Rockledge
provisions set forth in sections Bethesda, MD 20892, 3014351221, Dr., Rm. 4158, MSC 7806, Bethesda, MD
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., andrea.keane-myers@nih.gov. 20892, 301 435 1256, biesj@mail.nih.gov.
as amended. The grant applications and Name of Committee: Center for Scientific Name of Committee: Center for Scientific
the discussions could disclose Review Special Emphasis Panel Fellowships: Review Special Emphasis Panel Member
confidential trade secrets or commercial Oncological Sciences. Conflict: Auditory Mechanisms.
property such as patentable material, Date: July 13–14, 2015. Date: July 20–21, 2015.
and personal information concerning Time: 8:00 a.m. to 5:00 p.m. Time: 8:00 a.m. to 6:00 p.m.
individuals associated with the grant Agenda: To review and evaluate grant Agenda: To review and evaluate grant
applications, the disclosure of which applications. applications.
would constitute a clearly unwarranted Place: National Institutes of Health, 6701 Place: National Institutes of Health, 6701
invasion of personal privacy. Rockledge Drive, Bethesda, MD 20892 Rockledge Drive, Bethesda, MD (Virtual
(Virtual Meeting). Meeting).
Name of Committee: Center for Scientific Contact Person: Ola Mae Zack Howard, Contact Person: John Bishop, Ph.D.,
Review Special Emphasis Panel Member Ph.D., Scientific Review Officer, Center for Scientific Review Officer, Center for
Conflict: Neurobiology of Psychiatric
Scientific Review, National Institutes of Scientific Review, National Institutes of
Disorders and Addictions.
Health, 6701 Rockledge Dr., Room 4192, MSC Health, 6701 Rockledge Drive, Room 5182,
Date: June 24, 2015.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
7806, Bethesda, MD 20892, 301–451–4467, MSC 7844, Bethesda, MD 20892, (301) 408–
Time: 12:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant howardz@mail.nih.gov. 9664, bishopj@csr.nih.gov.
applications. Name of Committee: Center for Scientific Name of Committee: Center for Scientific
Place: National Institutes of Health, 6701 Review Special Emphasis Panel Member Review Special Emphasis Panel Member
Rockledge Drive, Bethesda, MD 20892 Conflict: Vascular Regulation and Diseases. Conflict: Topics in Virology.
(Telephone Conference Call). Date: July 16–17, 2015. Date: July 21, 2015
Contact Person: Boris P. Sokolov, Ph.D., Time: 10:00 a.m. to 6:00 p.m. Time: 10:00 a.m. to 6:00 p.m.
Scientific Review Officer, Center for Agenda: To review and evaluate grant Agenda: To review and evaluate grant
Scientific Review, National Institutes of applications. applications.
VerDate Sep<11>2014 18:47 Jun 16, 2015 Jkt 235001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 E:\FR\FM\17JNN1.SGM 17JNN1](https://thefederalregister.org/doc/80_FR_34800/page/2.svg)
Document Created: 2015-12-15 14:23:28
Document Modified: 2015-12-15 14:23:28
| 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 | |
| Contact | To obtain a copy of the data collection plans and instruments or request more information on the proposed project, contact: Dr. Kevin P. Conway, Deputy Director, Division of Epidemiology, Services, and Prevention Research, NIDA, NIH, 6001 Executive Boulevard, Room 5185, Rockville, MD 20852; or call non- toll-free number (301) 443-8755 or Email your request, including your | |
| FR Citation | 80 FR 34684 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR