80_FR_8919 80 FR 8886 - Submission for OMB Review; 30-Day Comment Request; Health Information National Trends Survey (HINTS) (NCI) [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer."> [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer." /> [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer." />

80 FR 8886 - Submission for OMB Review; 30-Day Comment Request; Health Information National Trends Survey (HINTS) (NCI)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 33 (February 19, 2015)

Page Range8886-8887
FR Document2015-03382

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 December 4, 2014 (Vol. 79, No. 233, pages 72003--4) and allowed 60 days for public comment. A total of five public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), 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.

Federal Register, Volume 80 Issue 33 (Thursday, February 19, 2015) 
[Federal Register Volume 80, Number 33 (Thursday, February 19, 2015)]
[Notices]
[Pages 8886-8887]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-03382]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; Health 
Information National Trends Survey (HINTS) (NCI)

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

[[Page 8887]]

listed below. This proposed information collection was previously 
published in the Federal Register on December 4, 2014 (Vol. 79, No. 
233, pages 72003--4) and allowed 60 days for public comment. A total of 
five public comments were received. The purpose of this notice is to 
allow an additional 30 days for public comment. The National Cancer 
Institute (NCI), 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, OIRA_submission@omb.eop.gov 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: Bradford W. Hesse, Ph.D., Health 
Communication and Informatics Research Branch, 9609 Medical Center 
Drive, MSC 9761, Room 3E610, Rockville, MD 20850 or call non-toll free 
number 240-276-6721 or Email your request, including your address, to 
hesseb@mail.nih.gov. Formal requests for additional plans and 
instruments must be requested in writing.
    Proposed Collection: Health Information National Trends Survey 
(HINTS) 0925-0538, Reinstatement with Change, National Cancer Institute 
(NCI), National Institutes of Health (NIH).
    Need and Use of Information Collection: This partnership between 
NCI and FDA will include assessing the public's knowledge of medical 
devices, communications related to product recalls, nutritional 
supplement labeling, and topics to inform FDA's regulatory authority 
over tobacco, such as risk perceptions about new tobacco products, 
product pack color gradations, perceptions of product harm, and tobacco 
product claims and labels. This HINTS survey will couple knowledge-
related questions with inquiries into the communication channels 
through which understanding is being obtained, and assessment of FDA-
regulated material. This survey will extend the information collected 
and priorities from HINTS which have been to provide a comprehensive 
assessment of the American public's current access to, and use of, 
information about cancer across the cancer care continuum from cancer 
prevention, early detection, diagnosis, treatment, and survivorship.
    OMB approval is requested for 1 year. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 2,159.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                  Number of      Average burden
             Type of respondents                 Number of      responses per     per response     Total annual
                                                respondents       respondent       (in hours)      burden hour
----------------------------------------------------------------------------------------------------------------
Individuals.................................           4,318                1            30/60            2,159
----------------------------------------------------------------------------------------------------------------


    Dated: February 9, 2015.
Karla Bailey,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2015-03382 Filed 2-18-15; 8:45 am]
BILLING CODE 4140-01-P

8886 Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices • A statement of either the quantity or ingredients, if the immediate product considered a collection of information volume of the repackaged drug product, label is too small to include this under the PRA because the information whichever is appropriate. information, and directions for use, is ‘‘originally supplied by the Federal • The date the drug product was including, as appropriate, dosage and Government to the recipient for the repackaged. administration, and the following purpose of disclosure to the public’’ (5 • The beyond-use-date of the information to facilitate adverse event CFR 1320.3(c)(2)). repackaged drug product. reporting: http://www.fda.gov/ We also estimate that annually a total • Storage and handling instructions medwatch and 1–800–FDA–1088. of approximately 10 outsourcing for the repackaged drug product. Another condition in the draft facilities (‘‘Number of Respondents’’ in • The National Drug Code (NDC) guidance is that each repackaged drug table 1, row 2) will each produce a copy number of the repackaged drug product, product is accompanied by a copy of the of prescribing information as set forth in if available.1 prescribing information that section III.A.11 of the draft guidance for • The statement ‘‘Not for resale,’’ and, accompanied the original drug product approximately 10 repackaged drug if the drug is distributed by an that was repackaged. products (‘‘Frequency per Disclosure’’ outsourcing facility other than pursuant We estimate that annually a total of in table 1, row 1) for a total of 100 to a prescription for an individual approximately 10 outsourcing facilities disclosures (‘‘total disclosures’’ in table identified patient, the statement ‘‘Office (‘‘Number of Respondents’’ in table 1, 1, row 2). We also estimate that Use Only.’’ row 1) will each design, test, and providing prescribing information • If included on the label of the FDA- produce approximately 10 different labeling will take approximately 1 hour approved drug product from which the labels (‘‘Frequency per Disclosure’’ in for each repackaged drug product drug product is being repackaged, a list table 1, row 1) for a total of 100 labels (‘‘Hours per Disclosure’’ in table 1, row of the active and inactive ingredients, that include the information set forth in 2). The provision to add http:// unless such information is included on section III.A.11 of the draft guidance www.fda.gov/medwatch and 1–800– the label for the container from which (including directions for use) (‘‘Total FDA–1088 is not included in this the individual units are removed, as Disclosures’’ in table 1, row 1). We also burden estimate because it is not described in this document. estimate that designing, testing, and considered a collection of information In addition, a condition in the draft producing each label will take under the PRA because the information guidance is that the label on the approximately 0.5 hours for each is ‘‘originally supplied by the Federal container from which the individual repackaged drug product (‘‘Hours per Government to the recipient for the units are removed for administration Disclosure’’ in table 1, row 1). The purpose of disclosure to the public’’ (5 (secondary packaging, e.g., the bag, box, provision to add the statement http:// CFR 1320.3(c)(2)). or other package in which the www.fda.gov/medwatch and 1–800– The total estimated third-party repackaged products are distributed) FDA–1088 is not included in this disclosure burden resulting from the includes the active and inactive burden estimate because it is not draft guidance is as follows: TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN Number of Frequency per Total Hours per Repackaging by outsourcing facilities Total hours respondents disclosure disclosures disclosure Designing, testing, and producing each label on immediate containers, packages and/or outer containers ................. 10 10 100 .5 50 Prescribing information labeling produced for each repack- aged drug product ............................................................ 10 10 100 1 100 Total .............................................................................. ........................ ........................ ........................ ........................ 150 There are no capital costs or operating and maintenance costs associated with this collection of information. *(30 minutes) The draft guidance also references V. Electronic Access DEPARTMENT OF HEALTH AND registration, product reporting, and HUMAN SERVICES CGMP requirements for outsourcing Persons with access to the Internet facilities. In the Federal Register of can obtain the document at either http:// National Institutes of Health December 4, 2013 (78 FR 72899), FDA www.fda.gov/Drugs/Guidance estimated the burden resulting from ComplianceRegulatoryInformation/ Submission for OMB Review; 30-Day outsourcing facility registration. In the Guidances/default.htm or http:// Comment Request; Health Information Federal Register of December 4, 2013 www.regulations.gov. National Trends Survey (HINTS) (NCI) (78 FR 72897), FDA estimated the Dated: February 11, 2015. SUMMARY: Under the provisions of burden resulting from outsourcing Leslie Kux, Section 3507(a)(1)(D) of the Paperwork facility interim product reporting. In the Associate Commissioner for Policy. Reduction Act of 1995, the National emcdonald on DSK67QTVN1PROD with NOTICES Federal Register of July 2, 2014 (79 FR [FR Doc. 2015–03417 Filed 2–18–15; 8:45 am] Institutes of Health (NIH), has submitted 37743), FDA estimated the burden BILLING CODE 4164–01–P to the Office of Management and Budget resulting from outsourcing facility (OMB) a request for review and compliance with CGMP requirements. approval of the information collection 1 The NDC number of the original approved drug product should not be placed on the repackaged drug product. VerDate Sep<11>2014 16:58 Feb 18, 2015 Jkt 235001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\19FEN1.SGM 19FEN1

Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices 8887 listed below. This proposed information DATES: Comment Due Date: Comments public’s knowledge of medical devices, collection was previously published in regarding this information collection are communications related to product the Federal Register on December 4, best assured of having their full effect if recalls, nutritional supplement labeling, 2014 (Vol. 79, No. 233, pages 72003— received within 30-days of the date of and topics to inform FDA’s regulatory 4) and allowed 60 days for public this publication. authority over tobacco, such as risk comment. A total of five public FOR FURTHER INFORMATION CONTACT: To perceptions about new tobacco comments were received. The purpose obtain a copy of the data collection products, product pack color gradations, of this notice is to allow an additional plans and instruments or request more perceptions of product harm, and 30 days for public comment. The information on the proposed project tobacco product claims and labels. This National Cancer Institute (NCI), contact: Bradford W. Hesse, Ph.D., HINTS survey will couple knowledge- National Institutes of Health, may not Health Communication and Informatics related questions with inquiries into the conduct or sponsor, and the respondent Research Branch, 9609 Medical Center communication channels through which is not required to respond to, an Drive, MSC 9761, Room 3E610, understanding is being obtained, and information collection that has been Rockville, MD 20850 or call non-toll assessment of FDA-regulated material. extended, revised, or implemented on or free number 240–276–6721 or Email This survey will extend the information after October 1, 1995, unless it displays your request, including your address, to collected and priorities from HINTS a currently valid OMB control number. hesseb@mail.nih.gov. Formal requests which have been to provide a Direct Comments To OMB: Written for additional plans and instruments comprehensive assessment of the comments and/or suggestions regarding must be requested in writing. American public’s current access to, and the item(s) contained in this notice, Proposed Collection: Health use of, information about cancer across especially regarding the estimated Information National Trends Survey the cancer care continuum from cancer public burden and associated response (HINTS) 0925–0538, Reinstatement with prevention, early detection, diagnosis, time, should be directed to the: Office Change, National Cancer Institute (NCI), treatment, and survivorship. of Management and Budget, Office of National Institutes of Health (NIH). OMB approval is requested for 1 year. Regulatory Affairs, OIRA_submission@ Need and Use of Information There are no costs to respondents other omb.eop.gov or by fax to 202–395–6974, Collection: This partnership between than their time. The total estimated Attention: NIH Desk Officer. NCI and FDA will include assessing the annualized burden hours are 2,159. ESTIMATED ANNUALIZED BURDEN HOURS Number of Average Number of responses burden per Total annual Type of respondents respondents per respond- response burden hour ent (in hours) Individuals ........................................................................................................ 4,318 1 30/60 2,159 Dated: February 9, 2015. would constitute a clearly unwarranted 7188; Bethesda, MD 20892–7924; 301–435– Karla Bailey, invasion of personal privacy. 0287; carolko@mail.nih.gov. NCI Project Clearance Liaison, National Name of Committee: National Heart, Lung, (Catalogue of Federal Domestic Assistance Institutes of Health. and Blood Institute Special Emphasis Panel; Program Nos. 93.233, National Center for Short-term Educational Experiences in Sleep Disorders Research; 93.837, Heart and [FR Doc. 2015–03382 Filed 2–18–15; 8:45 am] Hematology. Vascular Diseases Research; 93.838, Lung BILLING CODE 4140–01–P Diseases Research; 93.839, Blood Diseases Date: March 11, 2015. Time: 8:00 a.m. to 3:00 p.m. and Resources Research, National Institutes Agenda: To review and evaluate grant of Health, HHS). DEPARTMENT OF HEALTH AND applications. Dated: February 12, 2015. HUMAN SERVICES Place: Hyatt Regency Bethesda; One Michelle Trout, Bethesda Metro Center; 7400 Wisconsin National Institutes of Health Avenue; Bethesda, MD 20814. Program Analyst, Office of Federal Advisory Contact Person: Melissa E Nagelin, Ph.D.; Committee Policy. National Heart, Lung, and Blood Scientific Review Officer; Office of Scientific [FR Doc. 2015–03344 Filed 2–18–15; 8:45 am] Institute; Notice of Closed Meetings Review/DERA; National Heart, Lung, and BILLING CODE 4140–01–P Blood Institute; 6701 Rockledge Drive; Room Pursuant to section 10(d) of the 7202; Bethesda, MD 20892; 301–435–0297; Federal Advisory Committee Act, as nagelinmh2@nhlbi.nih.gov. DEPARTMENT OF HEALTH AND amended (5 U.S.C. App.), notice is Name of Committee: National Heart, Lung, HUMAN SERVICES hereby given of the following meetings. and Blood Institute Special Emphasis Panel; International Strategic Timing of National Institutes of Health The meetings will be closed to the Antiretroviral Therapy. public in accordance with the Date: March 13, 2015. National Heart, Lung, and Blood provisions set forth in sections Time: 11:00 a.m. to 1:00 p.m. Institute; Notice of Closed Meeting emcdonald on DSK67QTVN1PROD with NOTICES 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Agenda: To review and evaluate grant as amended. The grant applications and applications. Pursuant to section 10(d) of the the discussions could disclose Place: National Institutes of Health; 6705 Federal Advisory Committee Act, as Rockledge Drive, Room 7188; Bethesda, MD confidential trade secrets or commercial 20817; (Telephone Conference Call). amended (5 U.S.C. App.), notice is property such as patentable material, Contact Person: Chang Sook Kim, Ph.D.; hereby given of the following meeting. and personal information concerning Scientific Review Officer; Office of Scientific The meeting will be closed to the individuals associated with the grant Review/DERA; National Heart, Lung, and public in accordance with the applications, the disclosure of which Blood Institute; 6701 Rockledge Drive; Room provisions set forth in sections VerDate Sep<11>2014 16:58 Feb 18, 2015 Jkt 235001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\19FEN1.SGM 19FEN1


Document Created: 2018-02-16 11:12:44
Document Modified: 2018-02-16 11:12:44
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
DatesComment 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.
ContactTo obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: Bradford W. Hesse, Ph.D., Health Communication and Informatics Research Branch, 9609 Medical Center Drive, MSC 9761, Room 3E610, Rockville, MD 20850 or call non-toll free
FR Citation80 FR 8886 
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR