80 FR 38217 - Agency Information Collection Activities; Proposed Collection; Public Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 127 (July 2, 2015)

Page Range		38217-38218
FR Document		2015-16256

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 an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0937-0166, which expires on October 31, 2015. Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

Federal Register, Volume 80 Issue 127 (Thursday, July 2, 2015)

[Federal Register Volume 80, Number 127 (Thursday, July 2, 2015)]
[Notices]
[Pages 38217-38218]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-16256]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: HHS-OS-0937-0166-60D]

Agency Information Collection Activities; Proposed Collection;
Public Comment Request

AGENCY: Office of Population Affairs, Office of the Assistant Secretary
for Health, HHS.

ACTION: Notice.

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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 an Information
Collection Request (ICR), described below, to the Office of Management
and Budget (OMB). The ICR is for extending the use of the approved
information collection assigned OMB control number 0937-0166, which
expires on October 31, 2015. Prior to submitting the ICR to OMB, OS
seeks comments from the public regarding the burden estimate, below, or
any other aspect of the ICR.

DATES: Comments on the ICR must be received on or before August 31,
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-0937-0166-
60D for reference.
Information Collection Request Title: HHS 42 CFR part 50, subpart
B; Sterilization of Persons in Federally Assisted Family Planning
Projects--OMB No. 0937-0166-Extension--OASH, Office of Population
Affairs--Office of Family Planning

[[Page 38218]]

Abstract: This is a request for extension of a currently approved
collection for the disclosure and record-keeping requirements codified
at 42 CFR part 50, subpart B (``Sterilization of Persons in Federally
Assisted Family Planning Projects''). The consent form solicits
information to assure voluntary and informed consent to persons
undergoing sterilization in programs of health services which are
supported by federal financial assistance administered by the Public
Health Service (PHS). Consent forms are signed by individuals
undergoing a federally funded sterilization procedure and certified by
necessary medical authorities. Forms are incorporated into the
patient's medical records and the agency's records. Through periodic
site audits and visits, PHS staff review completed consent forms to
determine compliance with the regulation. Thus, the purpose of the
consent form is twofold. First, it serves as a mechanism to ensure that
a person receives information about sterilization and voluntarily
consents to the procedure. Second, it facilitates compliance
monitoring. The Sterilization Consent Form has been revised to reflect
a new expiration date on the Required Consent Form. There are no other
revisions to the form.
Likely Respondents: Interested persons who desire to send comments
regarding this burden estimate or any other aspect of this collection
of information that OS specifically requests comments.

Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Number of
Type of respondent Information Number of responses per Average burden Total hours
collection respondents respondent per response
----------------------------------------------------------------------------------------------------------------
Citizens Seeking Sterilization Information 100,000 1 1 100,000
Disclosure for
Sterilization
Consent Form.
Citizens Seeking Sterilization Record-keeping 100,000 1 15/60 25,000
for
Sterilization
Consent Form.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 125,000
----------------------------------------------------------------------------------------------------------------

OS specifically requests comments on (1) the necessity and utility
of the proposed information collection for the proper performance of
the agency's functions, (2) the accuracy of the estimated burden, (3)
ways to enhance the quality, utility, and clarity of the information to
be collected, and (4) the use of automated collection techniques or
other forms of information technology to minimize the information
collection burden.

Terry S. Clark,
Asst Information Collection Clearance Officer.
[FR Doc. 2015-16256 Filed 7-1-15; 8:45 am]
BILLING CODE 4150-34-P

Federal Register / Vol. 80, No. 127 / Thursday, July 2, 2015 / Notices 38217

discuss the disease, its impact on • Disease areas for which aspects of prepare for these upcoming meetings,
patients’ daily lives, the types of the disease are not formally captured in and information on how stakeholders
treatment benefit that matter most to clinical trials; may leverage the Patient-Focused Drug
patients, and patients’ perspectives on • Disease areas for which there are Development Initiative to generate input
the adequacy of available therapies. currently no therapies or very few on disease areas not addressed through
These meetings include participation of therapies, or the available therapies do the Patient-Focused Drug Development
FDA review divisions, the relevant not directly affect how a patient feels, PDUFA V commitment. The Web site
patient community, and other interested functions, or survives; and will be updated as new information
stakeholders. • Disease areas that have a severe becomes available.
impact on identifiable subpopulations Dated: June 26, 2015.
II. Disease Area Selection
(such as children or the elderly). Leslie Kux,
On October 8, 2014, FDA published a FDA’s selection also reflects disease
Associate Commissioner for Policy.
Federal Register notice (79 FR 60857) areas from FDA review divisions that
[FR Doc. 2015–16359 Filed 7–1–15; 8:45 am]
that requested public comment on were not covered by the meetings held
during FYs 2013–15. For its FYs 2016– BILLING CODE 4164–01–P
potential disease areas to be addressed
in FYs 2016–2017. In that notice, based 2017 list of disease areas, FDA has
on several criteria listed, FDA identified added a broad range of diseases based
upon disease severity (less severe to DEPARTMENT OF HEALTH AND
16 disease areas as potential candidates HUMAN SERVICES
for remaining public meetings and more severe) and upon the size of the
invited public comment on the affected population (rare diseases to [Document Identifier: HHS–OS–0937–0166–
preliminary list and on disease areas more prevalent diseases). FDA has 60D]
that were not listed. identified the following diseases to be
the focus of meetings scheduled in FYs Agency Information Collection
Following publication of the notice, 2016–2017: Activities; Proposed Collection; Public
almost 2,700 comments addressing over Comment Request
50 disease areas were submitted by • Alopecia areata
patients, patient advocates and • Autism AGENCY: Office of Population Affairs,
advocacy groups, caregivers, healthcare • Hereditary angioedema Office of the Assistant Secretary for
providers, professional societies, • Non-tuberculous mycobacterial Health, HHS.
scientific and academic experts, infections
ACTION: Notice.
pharmaceutical companies, and others. • Patients who have received an organ
The majority of comments received transplant SUMMARY: In compliance with section
• Psoriasis 3506(c)(2)(A) of the Paperwork
were submitted by individual patients.
• Neuropathic pain associated with Reduction Act of 1995, the Office of the
The comments focused generally on
peripheral neuropathy Secretary (OS), Department of Health
nominating individual disease areas or
• Sarcopenia and Human Services, announces plans
groups of disease areas to be addressed
and on providing general suggestions for A schedule of the meetings planned to submit an Information Collection
the Patient-Focused Drug Development can be found at the FDA Patient- Request (ICR), described below, to the
Initiative. The comments received also Focused Drug Development Web site, Office of Management and Budget
discussed the impact of these which is described in section III of this (OMB). The ICR is for extending the use
nominated diseases on the patients’ notice. The Agency recognizes that there of the approved information collection
daily lives, the symptoms that were are many more disease areas than can be assigned OMB control number 0937–
most concerning to patients, and the addressed in the planned FDA meetings 0166, which expires on October 31,
nature of (or lack of) specific treatments under the formal PDUFA V 2015. Prior to submitting the ICR to
for these diseases. The majority of commitment, and FDA will seek other OMB, OS seeks comments from the
comments received concerned lewy opportunities to gather public input on public regarding the burden estimate,
body dementia, frontotemporal lobar disease areas not addressed through this below, or any other aspect of the ICR.
degeneration, and neuropathies. Other Patient-Focused Drug Development DATES: Comments on the ICR must be
disease areas, such as hereditary Initiative. FDA encourages stakeholders received on or before August 31, 2015.
angioedema, dystonia, to identify and organize patient-focused
ADDRESSES: Submit your comments to
temporomandibular disorders, lupus, collaborations to generate public input
Information.CollectionClearance@
alopecia areata, chronic lymphocytic on other disease areas using the process
hhs.gov or by calling (202) 690–6162.
leukemia, trigeminal neuralgia, and established through this Patient-
Focused Drug Development Initiative as FOR FURTHER INFORMATION CONTACT:
arachnoiditis, also received a significant Information Collection Clearance staff,
number of comments. a model. Information on additional
opportunities for gathering patient input Information.CollectionClearance@
In selecting the disease areas of focus can be found on the Patient-Focused hhs.gov or (202) 690–6162.
for the Patient-Focused Drug Drug Development Web site. SUPPLEMENTARY INFORMATION: When
Development Initiative of FYs 2016– submitting comments or requesting
2017, FDA carefully considered the III. Patient-Focused Drug Development information, please include the
valuable public comments received, the Web Site document identifier HHS–OS–0937–
asabaliauskas on DSK5VPTVN1PROD with NOTICES

perspectives of reviewing divisions at FDA’s Web site on Patient-Focused 0166–60D for reference.
FDA, and the following selection Drug Development is available online at Information Collection Request Title:
criteria, which were published in the http://www.fda.gov/ForIndustry/ HHS 42 CFR part 50, subpart B;
October 8, 2014, Federal Register UserFees/PrescriptionDrugUserFee/ Sterilization of Persons in Federally
notice: ucm326192.htm. This Web site contains Assisted Family Planning Projects—
• Disease areas that are chronic, the general schedule of upcoming OMB No. 0937–0166–Extension—
symptomatic, or affect functioning and meetings for FYs 2016–2017, OASH, Office of Population Affairs—
activities of daily living; information on how stakeholders can Office of Family Planning

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38218 Federal Register / Vol. 80, No. 127 / Thursday, July 2, 2015 / Notices

Abstract: This is a request for by individuals undergoing a federally Second, it facilitates compliance
extension of a currently approved funded sterilization procedure and monitoring. The Sterilization Consent
collection for the disclosure and record- certified by necessary medical Form has been revised to reflect a new
keeping requirements codified at 42 authorities. Forms are incorporated into expiration date on the Required Consent
CFR part 50, subpart B (‘‘Sterilization of the patient’s medical records and the Form. There are no other revisions to
Persons in Federally Assisted Family agency’s records. Through periodic site the form.
Planning Projects’’). The consent form audits and visits, PHS staff review
solicits information to assure voluntary completed consent forms to determine Likely Respondents: Interested
and informed consent to persons compliance with the regulation. Thus, persons who desire to send comments
undergoing sterilization in programs of the purpose of the consent form is regarding this burden estimate or any
health services which are supported by twofold. First, it serves as a mechanism other aspect of this collection of
federal financial assistance to ensure that a person receives information that OS specifically
administered by the Public Health information about sterilization and requests comments.
Service (PHS). Consent forms are signed voluntarily consents to the procedure.

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of Average
Number of
Type of respondent Information collection responses per burden per Total hours
respondents respondent response

Citizens Seeking Sterilization Information Disclosure for Sterilization 100,000 1 1 100,000
Consent Form.
Citizens Seeking Sterilization Record-keeping for Sterilization Consent 100,000 1 15/60 25,000
Form.

Total ................................ ..................................................................... ........................ ........................ ........................ 125,000

OS specifically requests comments on applications, the disclosure of which DEPARTMENT OF HEALTH AND
(1) the necessity and utility of the would constitute a clearly unwarranted HUMAN SERVICES
proposed information collection for the invasion of personal privacy.
proper performance of the agency’s National Institutes of Health
Name of Committee: National Cancer
functions, (2) the accuracy of the Institute Special Emphasis Panel, NCI
estimated burden, (3) ways to enhance Center for Scientific Review; Notice of
Program Project Meeting 1 (P01). Closed Meetings
the quality, utility, and clarity of the Date: October 8–9, 2015.
information to be collected, and (4) the Time: 8:00 a.m. to 5:00 p.m.
use of automated collection techniques Pursuant to section 10(d) of the
Agenda: To review and evaluate grant Federal Advisory Committee Act, as
or other forms of information applications.
technology to minimize the information amended (5 U.S.C. App.), notice is
Place: Bethesda North Marriott Hotel &
collection burden. hereby given of the following meetings.
Conference Center, 5701 Marinelli Road,
Terry S. Clark, North Bethesda, MD 20852. The meetings will be closed to the
Contact Person: Caterina Bianco, MD, public in accordance with the
Asst Information Collection Clearance
Officer. Ph.D., Scientific Review Officer, Research provisions set forth in sections
Program Review Branch, Division of 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
[FR Doc. 2015–16256 Filed 7–1–15; 8:45 am]
Extramural Activities, National Cancer as amended. The grant applications and
BILLING CODE 4150–34–P
Institute, NIH, 9609 Medical Center Drive, the discussions could disclose
Room 7W610, Bethesda, MD 20892–9750, confidential trade secrets or commercial
240–276–6459, biancoc@mail.nih.gov. property such as patentable material,
DEPARTMENT OF HEALTH AND
(Catalogue of Federal Domestic Assistance and personal information concerning
HUMAN SERVICES
Program Nos. 93.392, Cancer Construction; individuals associated with the grant
National Institutes of Health 93.393, Cancer Cause and Prevention applications, the disclosure of which
Research; 93.394, Cancer Detection and would constitute a clearly unwarranted
National Cancer Institute Notice of Diagnosis Research; 93.395, Cancer invasion of personal privacy.
Closed Meeting Treatment Research; 93.396, Cancer Biology Name of Committee: Center for Scientific
Research; 93.397, Cancer Centers Support; Review Special Emphasis Panel; Member
Pursuant to section 10(d) of the
93.398, Cancer Research Manpower; 93.399, Conflicts: Cardiovascular Sciences.
Federal Advisory Committee Act, as
Cancer Control, National Institutes of Health, Date: July 20, 2015.
amended (5 U.S.C. App.), notice is
HHS) Time: 12:00 p.m. to 5:00 p.m.
hereby given of the following meeting.
Agenda: To review and evaluate grant
The meeting will be closed to the Dated: June 26, 2015.
applications.
public in accordance with the
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Melanie J. Gray, Place: National Institutes of Health, 6701
provisions set forth in sections 552b(c) Program Analyst, Office of Federal Advisory Rockledge Drive, Bethesda, MD 20892,
(4) and 552b(c) (6), Title 5 U.S.C., as Committee Policy. (Virtual Meeting).
amended. The grant applications and [FR Doc. 2015–16213 Filed 7–1–15; 8:45 am] Contact Person: Sara Ahlgren, Ph.D.,
the discussions could disclose Scientific Review Officer, Center for
BILLING CODE 4140–01–P
confidential trade secrets or commercial Scientific Review, National Institutes of
property such as patentable material, Health, 6701 Rockledge Drive, RM 4136,
and personal information concerning Bethesda, MD 20892, 301–435–0904,
individuals associated with the grant sara.ahlgren@nih.gov.

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Document Created: 2015-12-15 13:16:19
Document Modified: 2015-12-15 13:16:19

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 August 31, 2015.
Contact		Information Collection Clearance staff, [email protected] or (202) 690-6162.
FR Citation		80 FR 38217