80 FR 34683 - Agency Information Collection Activities; Proposed Collection; Public Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary

Federal Register Volume 80, Issue 116 (June 17, 2015)

Page Range		34683-34684
FR Document		2015-14850

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.

Federal Register, Volume 80 Issue 116 (Wednesday, June 17, 2015)

[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Notices]
[Pages 34683-34684]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-14850]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

[Document Identifier: HHS-OS-0990-new-30D]

Agency Information Collection Activities; Proposed Collection;
Public Comment Request

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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

SUMMARY: In compliance with section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the Office of the Secretary (OS), Department of
Health and Human Services, announces plans to submit a new Information
Collection Request (ICR), described below, to the Office of Management
and Budget (OMB). Comments submitted during the first public review of
this ICR will be provided to OMB. OMB will accept further comments from
the public on this ICR during the review and approval period.

DATES: Comments on the ICR must be received on or before July 17, 2015.

ADDRESSES: Submit your comments to
Information.CollectionClearance@hhs.gov or by calling (202) 690-6162.

FOR FURTHER INFORMATION CONTACT: Information Collection Clearance
staff, Information.CollectionClearance@hhs.gov or (202) 690-6162.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the document identifier HHS-OS-0990-new-30D
for reference. Information Collection Request Title: Title X
Sustainability Assessment Tool for Grantees and Service Sites.
Abstract: The Office of Population Affairs within the Office of the
Assistant Secretary for Health seeks to collect data from the Title X
centers on efforts related to (1) assisting individuals in obtaining
health insurance; (2) partnerships with primary care providers; (3)
availability and use of electronic health records; (4) monitoring
patient care quality; (5) factors affecting revenue sources; and (6)
the way that sites conduct analyses to consider the cost of providing
services.
Need and Proposed Use of the Information: The Title X Family
Planning Program (``Title X program'' or ``program'') is the only
Federal grant program dedicated solely to providing individuals with
comprehensive family planning and related preventive health services
(e.g., screening for breast and cervical cancer, sexually transmitted
diseases (STDs), and human immunodeficiency virus [HIV]). By law,
priority is given to persons from low-income families (Section 1006[c]
of Title X of the Public Health Service Act, 42 U.S.C. 300). The Office
of Population Affairs (OPA) within the Office of the Assistant
Secretary for Health administers the Title X program.
The American health care system is experiencing unprecedented
levels of change as a result of the Patient Protection and Affordable
Care Act (ACA). The exact impact of these health system changes to
Title X centers needs to be assessed in order to ensure the

[[Page 34684]]

long term sustainability of the Title X network.
Data collected from this effort will be used to inform the work of
the training centers so they can better support the Title X grantees.
This data will help OPA better understand challenges affecting Title X
centers in order to better work with HHS entities and national
stakeholders to provide resources to Title X centers. Data will be
collected through an online data collection tool directly from grantees
and from Title X centers.
Likely Respondents: This annual reporting requirement is service
sites that receive funding (either directly from OPA or through a sub
recipient or grantee agency) for family planning services authorized
and funded by the Title X Family Planning Program [``Population
Research and Voluntary Family Planning Programs'' (91)], which was
enacted in 1970 as Title X of the Public Health Service Act (Section
1001 of Title X of the Public Health Service Act, 42 United States Code
[U.S.C.] 300).

Total Estimated Annualized Burden--Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average
Number of annualized
Type of respondent Form name Number of responses per burden per Annual total
respondents respondent response burden (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,
Asst Information Collection Clearance Officer.
[FR Doc. 2015-14850 Filed 6-16-15; 8:45 am]
BILLING CODE 4150-48-P

Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices 34683

Medical Device Reporting (MDR) (part 814, subpart E (21 CFR part 814, subpart annual reports a summary of adverse
803 (21 CFR part 803)). The reporting of E), including the submission of periodic reactions maintained by the collecting
adverse device events summarized in an reports under § 814.84. or transfusing facility, or similar reports
annual report will alert FDA to trends Collecting or transfusing facilities and of adverse events collected, in addition
or clusters of events that might be a manufacturers have certain to those required under the MDR
safety issue otherwise unreported under responsibilities under Federal regulation. The MedWatch medical
the MDR regulation. regulations. For example, collecting or device reporting code instructions
Reclassification of this device from transfusing facilities are required to (http://www.fda.gov/MedicalDevices/
class III to class II for the intended use maintain records of any reports of DeviceRegulationandGuidance/
of routine collection of blood and blood complaints of adverse reactions (21 CFR GuidanceDocuments/ucm106737.htm)
components relieves manufacturers of 606.170), while the manufacturer is contains a comprehensive list of adverse
the burden of complying with the responsible for conducting an events associated with device use,
premarket approval requirements of investigation of each event that is including most of those events that we
section 515 of the FD&C Act (21 U.S.C. reasonably known to the manufacturer recommend summarizing in the annual
360e), and may permit small potential and evaluating the cause of the event report.
competitors to enter the marketplace by (§ 803.50(b)). In addition, manufacturers In the Federal Register of January 29,
reducing the burden. Although the of medical devices are required to 2015 (80 FR 4927), FDA published a 60-
special control guidance recommends submit to FDA individual adverse event day notice requesting public comment
that manufacturers of these devices file reports of death, serious injury, and on the proposed collection of
with FDA an annual report for 3 malfunctions (§ 803.50). information. No comments were
consecutive years, this would be less In the special control guidance received.
burdensome than the current document, FDA recommends that FDA estimates the burden of this
postapproval requirements under part manufacturers include in their three collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Reporting activity responses per burden per Total hours
respondents responses
respondent response

Annual Report ...................................................................... 4 1 4 5 20
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on FDA records, there are SUMMARY: In compliance with section from the Title X centers on efforts
approximately four manufacturers of 3506(c)(2)(A) of the Paperwork related to (1) assisting individuals in
automated blood cell separator devices. Reduction Act of 1995, the Office of the obtaining health insurance; (2)
The estimated average burden per Secretary (OS), Department of Health partnerships with primary care
response is based on the time that the and Human Services, announces plans providers; (3) availability and use of
manufacturers will spend preparing and to submit a new Information Collection electronic health records; (4) monitoring
submitting the annual report. Request (ICR), described below, to the patient care quality; (5) factors affecting
Other burden hours required for Office of Management and Budget revenue sources; and (6) the way that
§ 864.9245 are reported and approved (OMB). Comments submitted during the sites conduct analyses to consider the
under OMB control number 0910–0120 first public review of this ICR will be cost of providing services.
(premarket notification submission provided to OMB. OMB will accept Need and Proposed Use of the
501(k), 21 CFR part 807, subpart E), and further comments from the public on Information: The Title X Family
OMB control number 0910–0437 (MDR, this ICR during the review and approval Planning Program (‘‘Title X program’’ or
part 803). period. ‘‘program’’) is the only Federal grant
Dated: June 10, 2015. DATES: Comments on the ICR must be program dedicated solely to providing
Leslie Kux, received on or before July 17, 2015. individuals with comprehensive family
planning and related preventive health
Associate Commissioner for Policy. ADDRESSES: Submit your comments to
services (e.g., screening for breast and
[FR Doc. 2015–14889 Filed 6–16–15; 8:45 am] Information.CollectionClearance@
cervical cancer, sexually transmitted
BILLING CODE 4164–01–P hhs.gov or by calling (202) 690–6162.
diseases (STDs), and human
FOR FURTHER INFORMATION CONTACT: immunodeficiency virus [HIV]). By law,
Information Collection Clearance staff, priority is given to persons from low-
DEPARTMENT OF HEALTH AND Information.CollectionClearance@ income families (Section 1006[c] of Title
HUMAN SERVICES hhs.gov or (202) 690–6162. X of the Public Health Service Act, 42
SUPPLEMENTARY INFORMATION: When U.S.C. 300). The Office of Population
Office of the Secretary
submitting comments or requesting Affairs (OPA) within the Office of the
[Document Identifier: HHS–OS–0990–new– information, please include the Assistant Secretary for Health
asabaliauskas on DSK5VPTVN1PROD with NOTICES

30D] document identifier HHS–OS–0990– administers the Title X program.
new–30D for reference. Information The American health care system is
Agency Information Collection Collection Request Title: Title X experiencing unprecedented levels of
Activities; Proposed Collection; Public Sustainability Assessment Tool for change as a result of the Patient
Comment Request Grantees and Service Sites. Protection and Affordable Care Act
AGENCY: Office of the Secretary, HHS. Abstract: The Office of Population (ACA). The exact impact of these health
Affairs within the Office of the Assistant system changes to Title X centers needs
ACTION: Notice.
Secretary for Health seeks to collect data to be assessed in order to ensure the

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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

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Document Created: 2015-12-15 14:22:43
Document Modified: 2015-12-15 14:22:43

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
Action		Notice.
Dates		Comments on the ICR must be received on or before July 17, 2015.
Contact		Information Collection Clearance staff, [email protected] or (202) 690-6162.
FR Citation		80 FR 34683

80 FR 34683 - Agency Information Collection Activities; Proposed Collection; Public Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESOffice of the Secretary

Federal Register Volume 80, Issue 116 (June 17, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary