81 FR 43217 - Submission for OMB Review; 30-Day Comment Request; Population Assessment of Tobacco and Health (PATH) Study-Fourth Wave of Data Collection
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 127 (July 1, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 127 (July 1, 2016)
| Page Range | 43217-43219 | |
| FR Document | 2016-15644 |
[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)] [Notices] [Pages 43217-43219] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-15644] ----------------------------------------------------------------------- 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--Fourth Wave of Data Collection AGENCY: National Institute of Health, HHS. 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 [[Page 43218]] collection was previously published in the Federal Register on April 15, 2016, pages 22290--22291 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The 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. 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, 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: [email protected]. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Population Assessment of Tobacco and Health (PATH) Study--Fourth Wave of Data Collection (NIDA), 0925-0664, expiration date 8/31/2018--REVISION--NIDA, NIH, in partnership with the Food and Drug Administration (FDA). Need and Use of Information Collection: This is a revision request (OMB number 0925-0664, expiration date 8/31/2018) for the Population Assessment of Tobacco and Health (PATH) Study to conduct the fourth 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. On an annual basis, the PATH Study conducts interviews with and collects biospecimens from adults and youth 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 costs to respondents other than their time. The total estimated annualized burden hours are 94,798. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Total Number of Number of burden per annual Form name Type of respondent respondents responses per response burden respondent (in hours) hours ---------------------------------------------------------------------------------------------------------------- 1. Household Screener............ Households.............. 48,018 1 14/60 11,204 2. Individual Screener........... Adults--New adults...... 9,152 1 6/60 915 3. Extended Interview............ Adults--New adults and 10,737 1 68/60 12,169 Wave 1 youth respondents who age up to adult cohort at Wave 4. 4. Extended Interview............ Adults--Adult 23,414 1 1 23,414 respondents at previous wave. 5. Parent Interview.............. Adults--Parents of new 6,561 1 19/60 2,078 youth and parents of shadow youth who age up to youth cohort at Wave 4. 6. Parent Interview.............. Adults--Parents of youth 8,800 1 16/60 2,347 respondents at previous wave. 7. Extended Interview............ Youth--New youth and 6,432 1 45/60 4,824 shadow youth who age up to youth cohort at Wave 4. 8. Extended Interview............ Youth--Youth respondents 8,627 1 35/60 5,032 at previous wave. 9. Tobacco Use Form.............. Adults.................. 23,133 1 5/60 1,928 10. Tobacco Use Form............. Youth................... 10,239 1 5/60 853 11. Shadow Youth Only Screener... Households.............. 41,207 1 5/60 3,434 12. Verification Interview....... Adults.................. 33,889 1 2/60 1,130 13. Validation Interview......... Adults.................. 301 1 4/60 20 14. Biospecimen Collection: Blood Adults--New adults and 4,832 1 18/60 1,450 Wave 1 youth respondents who age up to adult cohort at Wave 4. 15. Biospecimen Collection: Urine Adults.................. 18,301 1 10/60 3,050 16. Biospecimen Collection: Urine Youth................... 10,239 1 10/60 1,707 17. Follow-up/Tracking Adults.................. 34,151 2 8/60 9,107 Participant Information Form. 18. Follow-up/Tracking Adults--Parents of youth 15,059 2 8/60 4,016 Participant Information Form for respondents. Youth (completed by parents). [[Page 43219]] 19. Follow-up/Tracking Adults--Parents of 4,684 2 8/60 1,249 Participant Information Form for shadow youth. sample shadow youth (completed by parents). 20. Consent for Extended Adults--New adults and 13,984 1 4/60 932 Interview. Wave 1 youth respondents who age up to adult cohort at Wave 4. 21. Parent Permission and Consent Adults--Parents of new 7,657 1 5/60 638 for Parent Interview. youth and parents of Shadow youth who age up to youth cohort at Wave 4. 22. Assent for Extended Interview Youth--New youth and 7,657 1 3/60 383 shadow youth who age up to youth cohort at Wave 4. 23. Consent for Biological Adults--New adults and 10,737 1 5/60 895 Samples. Wave 1 youth respondents who age up to adult cohort at Wave 4. 24. Parent permission for urine Adults--Parents of youth 15,360 1 3/60 768 collection. respondents at previous wave. 25. Assent for urine collection.. Youth................... 15,059 1 5/60 1,255 ---------------------------------------------------- Total........................ ........................ 388,229 442,123 ........... 94,798 ---------------------------------------------------------------------------------------------------------------- Dated: June 27, 2016. Genevieve deAlmeida, Project Clearance Liaison, National Institute on Drug Abuse, NIH. [FR Doc. 2016-15644 Filed 6-30-16; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices 43217
Dated: June 27, 2016. and Clinicians; 93.272, Alcohol National Name of Committee: National Institute on
Jennifer Spaeth, Research Service Awards for Research Alcohol Abuse and Alcoholism Special
Training; 93.273, Alcohol Research Programs; Emphasis Panel; U01 Application Review.
Director, Office of Federal Advisory
93.891, Alcohol Research Center Grants; Date: July 13, 2016.
Committee Policy.
93.701, ARRA Related Biomedical Research Time: 11:00 a.m. to 3:00 p.m.
[FR Doc. 2016–15643 Filed 6–30–16; 8:45 am] and Research Support Awards, National Agenda: To review and evaluate grant
BILLING CODE 4140–01–P Institutes of Health, HHS) applications.
Place: National Institutes of Health,
Dated: June 27, 2016. National Institute on Alcohol Abuse and
DEPARTMENT OF HEALTH AND Melanie J. Gray, Alcoholism, 5635 Fishers Lane, Rockville,
HUMAN SERVICES MD 20892, (Telephone Conference Call).
Program Analyst, Office of Federal Advisory Contact Person: Richard A. Rippe, Ph.D.,
Committee Policy. Scientific Review Officer, National Institute
National Institutes of Health [FR Doc. 2016–15592 Filed 6–30–16; 8:45 am] on Alcohol Abuse and Alcoholism, 5635
BILLING CODE 4140–01–P Fishers Lane, Room 2109, Rockville, MD
National Institute on Alcohol Abuse
20852, 301–443–8599, rippera@mail.nih.gov.
and Alcoholism; Notice of Closed
Name of Committee: National Institute on
Meetings Alcohol Abuse and Alcoholism Special
DEPARTMENT OF HEALTH AND
Pursuant to section 10(d) of the HUMAN SERVICES Emphasis Panel; Targets of Low Dose
Federal Advisory Committee Act, as Alcohol in the Brain.
National Institutes of Health Date: July 21, 2016.
amended (5 U.S.C. App.), notice is Time: 8:00 a.m. to 5:00 p.m.
hereby given of the following meetings. Agenda: To review and evaluate grant
National Cancer Institute; Cancellation
The meetings will be closed to the applications.
of Meeting
public in accordance with the Place: National Institutes of Health,
provisions set forth in sections Notice is hereby given of the
National Institute on Alcohol Abuse and
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Alcoholism, Conference Room 3002/3004,
cancellation of the National Cancer 5635 Fishers Lane, Rockville, MD 20892.
as amended. The grant applications and Institute Special Emphasis Panel, June
the discussions could disclose Contact Person: Philippe Marmillot, Ph.D.,
27, 2016, 11:00 a.m. to June 27, 2016, National Institutes of Health, National
confidential trade secrets or commercial 12:00 p.m., National Cancer Institute Institute on Alcohol Abuse and Alcoholism,
property such as patentable material, Shady Grove, 9609 Medical Center 5635 Fishers Lane, Rm 2017, Bethesda, MD
and personal information concerning Drive, 7W624, Rockville, MD, 20850 20892, 301–443–2861, marmillotp@
individuals associated with the grant which was published in the Federal mail.nih.gov.
applications, the disclosure of which Register on May 2, 2016, 81FR26240. (Catalogue of Federal Domestic Assistance
would constitute a clearly unwarranted Program Nos. 93.271, Alcohol Research
invasion of personal privacy. This meeting is canceled because the Career Development Awards for Scientists
applications were reassigned. and Clinicians; 93.272, Alcohol National
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism Special Dated: June 27, 2016. Research Service Awards for Research
Emphasis Panel; NIAAA Member Conflict Melanie J. Gray, Training; 93.273, Alcohol Research Programs;
Reviews—Clinical Sciences and 93.891, Alcohol Research Center Grants;
Program Analyst, Office of Federal Advisory 93.701, ARRA Related Biomedical Research
Epidemiology. Committee Policy.
Date: July 11, 2016. and Research Support Awards, National
[FR Doc. 2016–15591 Filed 6–30–16; 8:45 am] Institutes of Health, HHS)
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant BILLING CODE 4140–01–P
Dated: June 27, 2016.
applications. Melanie J. Gray,
Place: National Institutes of Health–
DEPARTMENT OF HEALTH AND Program Analyst, Office of Federal Advisory
NIAAA, 5635 Fishers Lane, Rockville, MD
Committee Policy.
20892 (Telephone Conference Call). HUMAN SERVICES
Contact Person: Richard A. Rippe, Ph.D., [FR Doc. 2016–15593 Filed 6–30–16; 8:45 am]
Scientific Review Officer, National Institute National Institutes of Health BILLING CODE 4140–01–P
on Alcohol Abuse and Alcoholism, National
Institutes of Health, 5635 Fishers Lane, Room National Institute on Alcohol Abuse
2109, Rockville, MD 20852, 301–443–8599, And Alcoholism; Notice of Closed DEPARTMENT OF HEALTH AND
rippera@mail.nih.gov. Meetings HUMAN SERVICES
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism Special Pursuant to section 10(d) of the National Institutes of Health
Emphasis Panel; NIAAA Fellowship Review. Federal Advisory Committee Act, as
Date: July 26, 2016. amended (5 U.S.C. App.), notice is Submission for OMB Review; 30-Day
Time: 8:00 a.m. to 3:00 p.m. hereby given of the following meetings. Comment Request; Population
Agenda: To review and evaluate grant Assessment of Tobacco and Health
applications. The meetings will be closed to the (PATH) Study—Fourth Wave of Data
Place: National Institutes of Health, public in accordance with the Collection
National Institute on Alcohol Abuse and provisions set forth in sections
Alcoholism, Terrace Level Conference Room 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., AGENCY: National Institute of Health,
508, 5635 Fishers LN, Rockville, MD 20892. as amended. The grant applications and HHS.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Contact Person: Richard A. Rippe, Ph.D., the discussions could disclose SUMMARY: Under the provisions of
Scientific Review Officer, National Institute
on Alcohol Abuse and Alcoholism, National
confidential trade secrets or commercial Section 3507(a)(1)(D) of the Paperwork
Institutes of Health, 5635 Fishers Lane, Room property such as patentable material, Reduction Act of 1995, the National
2109, Rockville, MD 20852, 301–443–8599, and personal information concerning Institutes of Health (NIH) has submitted
rippera@mail.nih.gov. individuals associated with the grant to the Office of Management and Budget
(Catalogue of Federal Domestic Assistance applications, the disclosure of which (OMB) a request for review and
Program Nos. 93.271, Alcohol Research would constitute a clearly unwarranted approval of the information collection
Career Development Awards for Scientists invasion of personal privacy. listed below. This proposed information
VerDate Sep<11>2014 19:05 Jun 30, 2016 Jkt 238001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\01JYN1.SGM 01JYN1](https://thefederalregister.org/doc/81_FR_43344/page/1.svg)
![Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices 43219
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average Total
Number of
Number of burden per annual
Form name Type of respondent responses per
respondents response burden
respondent (in hours) hours
19. Follow-up/Tracking Participant Adults—Parents of shadow youth ..................... 4,684 2 8/60 1,249
Information Form for sample
shadow youth (completed by par-
ents).
20. Consent for Extended Interview Adults—New adults and Wave 1 youth re- 13,984 1 4/60 932
spondents who age up to adult cohort at
Wave 4.
21. Parent Permission and Consent Adults—Parents of new youth and parents of 7,657 1 5/60 638
for Parent Interview. Shadow youth who age up to youth cohort at
Wave 4.
22. Assent for Extended Interview .. Youth—New youth and shadow youth who age 7,657 1 3/60 383
up to youth cohort at Wave 4.
23. Consent for Biological Samples Adults—New adults and Wave 1 youth re- 10,737 1 5/60 895
spondents who age up to adult cohort at
Wave 4.
24. Parent permission for urine col- Adults—Parents of youth respondents at pre- 15,360 1 3/60 768
lection. vious wave.
25. Assent for urine collection ......... Youth .................................................................. 15,059 1 5/60 1,255
Total ......................................... ............................................................................ 388,229 442,123 .................... 94,798
Dated: June 27, 2016. FOR FURTHER INFORMATION CONTACT: Dated: June 14, 2016.
Genevieve deAlmeida, Grace A. Kim, Valuation and Special Joanne R. Stump,
Project Clearance Liaison, National Institute Programs Branch, Regulations and Acting Executive Director, Regulations and
on Drug Abuse, NIH. Rulings, Office of International Trade Rulings, Office of International Trade.
[FR Doc. 2016–15644 Filed 6–30–16; 8:45 am] (202) 325–7941.
HQ H273091
BILLING CODE 4140–01–P SUPPLEMENTARY INFORMATION: Notice is
hereby given that on June 14, 2016, June 14, 2016
pursuant to subpart B of Part 177, U.S. OT:RR:CTF:VS H273091 GaK
Customs and Border Protection
DEPARTMENT OF HOMELAND Regulations (19 CFR part 177, subpart CATEGORY: Origin
SECURITY B), CBP issued a final determination Janet C. Wallett
concerning the country of origin of FCI USA LLC.
U.S. Customs and Border Protection certain network cables and transceivers, 825 Old Trail Road
which may be offered to the U.S. Etters, PA 17319
Notice of Issuance of Final Government under an undesignated RE: U.S. Government Procurement; Country
Determination Concerning Certain government procurement contract. This of origin of copper cables containing
Network Cables and Transceivers final determination, HQ H273091, was transceivers and of the fiber optic
AGENCY: U.S. Customs and Border issued under procedures set forth at 19 transceiver; Substantial Transformation
Protection, Department of Homeland CFR part 177, subpart B, which Dear Ms. Wallett:
Security. implements Title III of the Trade This is in response to your letter dated
Agreements Act of 1979, as amended January 6, 2016, requesting a final
ACTION: Notice of final determination. (19 U.S.C. 2511–18). In the final determination on behalf of FCI USA LLC
determination, CBP concluded that the (‘‘FCI’’), pursuant to subpart B of part 177 of
SUMMARY: This document provides processing of the imported merchandise the U.S. Customs & Border Protection
notice that U.S. Customs and Border in the U.S. does not result in a (‘‘CBP’’) Regulations (19 CFR part 177).
Protection (‘‘CBP’’) has issued a final substantial transformation. Therefore, Under these regulations, which implement
determination concerning the country of the country of origin of the transceivers Title III of the Trade Agreements Act of 1979
origin of certain transceivers imported (‘‘TAA’’), as amended (19 U.S.C. § 2511 et
and of the network cables containing seq.), CBP issues country of origin advisory
separately and certain imported network transceivers is China for purposes of
cables containing transceivers. Based rulings and final determinations as to
U.S. Government procurement. whether an article is or would be a product
upon the facts presented, CBP has Section 177.29, CBP Regulations (19 of a designated country or instrumentality for
concluded in both instances that the CFR 177.29), provides that a notice of the purposes of granting waivers of certain
country of origin of the merchandise is final determination shall be published ‘‘Buy American’’ restrictions in U.S. law or
China for purposes of U.S. Government in the Federal Register within 60 days practice for products offered for sale to the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
procurement. of the date the final determination is U.S. Government. This final determination
DATES: The final determination was issued. Section 177.30, CBP Regulations concerns the country of origin of FCI’s
Copper Direct Attach Copper (‘‘DAC’’)
issued on June 14, 2016. A copy of the (19 CFR 177.30), provides that any
cable—HPL500 (‘‘Cable’’) and Fiber Optic
final determination is attached. Any party-at-interest, as defined in 19 CFR Transceivers—HPL512 (‘‘Transceivers’’). We
party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial review of a note that as a U.S. importer, FCI is a party-
177.22(d), may seek judicial review of final determination within 30 days of at-interest within the meaning of 19 CFR
this final determination within August publication of such determination in the § 177.22(d)(1) and is entitled to request this
1, 2016. Federal Register. final determination.
VerDate Sep<11>2014 19:05 Jun 30, 2016 Jkt 238001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\01JYN1.SGM 01JYN1](https://thefederalregister.org/doc/81_FR_43344/page/3.svg)
Document Created: 2016-07-14 11:37:15
Document Modified: 2016-07-14 11:37:15
| 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 | |
| Dates | Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. | |
| Contact | 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 | |
| FR Citation | 81 FR 43217 |
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