Agency Information Collection Activities; Proposed Collection; Public Comment Request, 38217-38218 [2015-16256]
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Federal Register / Vol. 80, No. 127 / Thursday, July 2, 2015 / Notices
discuss the disease, its impact on
patients’ daily lives, the types of
treatment benefit that matter most to
patients, and patients’ perspectives on
the adequacy of available therapies.
These meetings include participation of
FDA review divisions, the relevant
patient community, and other interested
stakeholders.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
II. Disease Area Selection
On October 8, 2014, FDA published a
Federal Register notice (79 FR 60857)
that requested public comment on
potential disease areas to be addressed
in FYs 2016–2017. In that notice, based
on several criteria listed, FDA identified
16 disease areas as potential candidates
for remaining public meetings and
invited public comment on the
preliminary list and on disease areas
that were not listed.
Following publication of the notice,
almost 2,700 comments addressing over
50 disease areas were submitted by
patients, patient advocates and
advocacy groups, caregivers, healthcare
providers, professional societies,
scientific and academic experts,
pharmaceutical companies, and others.
The majority of comments received
were submitted by individual patients.
The comments focused generally on
nominating individual disease areas or
groups of disease areas to be addressed
and on providing general suggestions for
the Patient-Focused Drug Development
Initiative. The comments received also
discussed the impact of these
nominated diseases on the patients’
daily lives, the symptoms that were
most concerning to patients, and the
nature of (or lack of) specific treatments
for these diseases. The majority of
comments received concerned lewy
body dementia, frontotemporal lobar
degeneration, and neuropathies. Other
disease areas, such as hereditary
angioedema, dystonia,
temporomandibular disorders, lupus,
alopecia areata, chronic lymphocytic
leukemia, trigeminal neuralgia, and
arachnoiditis, also received a significant
number of comments.
In selecting the disease areas of focus
for the Patient-Focused Drug
Development Initiative of FYs 2016–
2017, FDA carefully considered the
valuable public comments received, the
perspectives of reviewing divisions at
FDA, and the following selection
criteria, which were published in the
October 8, 2014, Federal Register
notice:
• Disease areas that are chronic,
symptomatic, or affect functioning and
activities of daily living;
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21:16 Jul 01, 2015
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• Disease areas for which aspects of
the disease are not formally captured in
clinical trials;
• Disease areas for which there are
currently no therapies or very few
therapies, or the available therapies do
not directly affect how a patient feels,
functions, or survives; and
• Disease areas that have a severe
impact on identifiable subpopulations
(such as children or the elderly).
FDA’s selection also reflects disease
areas from FDA review divisions that
were not covered by the meetings held
during FYs 2013–15. For its FYs 2016–
2017 list of disease areas, FDA has
added a broad range of diseases based
upon disease severity (less severe to
more severe) and upon the size of the
affected population (rare diseases to
more prevalent diseases). FDA has
identified the following diseases to be
the focus of meetings scheduled in FYs
2016–2017:
• Alopecia areata
• Autism
• Hereditary angioedema
• Non-tuberculous mycobacterial
infections
• Patients who have received an organ
transplant
• Psoriasis
• Neuropathic pain associated with
peripheral neuropathy
• Sarcopenia
A schedule of the meetings planned
can be found at the FDA PatientFocused Drug Development Web site,
which is described in section III of this
notice. The Agency recognizes that there
are many more disease areas than can be
addressed in the planned FDA meetings
under the formal PDUFA V
commitment, and FDA will seek other
opportunities to gather public input on
disease areas not addressed through this
Patient-Focused Drug Development
Initiative. FDA encourages stakeholders
to identify and organize patient-focused
collaborations to generate public input
on other disease areas using the process
established through this PatientFocused Drug Development Initiative as
a model. Information on additional
opportunities for gathering patient input
can be found on the Patient-Focused
Drug Development Web site.
III. Patient-Focused Drug Development
Web Site
FDA’s Web site on Patient-Focused
Drug Development is available online at
https://www.fda.gov/ForIndustry/
UserFees/PrescriptionDrugUserFee/
ucm326192.htm. This Web site contains
the general schedule of upcoming
meetings for FYs 2016–2017,
information on how stakeholders can
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38217
prepare for these upcoming meetings,
and information on how stakeholders
may leverage the Patient-Focused Drug
Development Initiative to generate input
on disease areas not addressed through
the Patient-Focused Drug Development
PDUFA V commitment. The Web site
will be updated as new information
becomes available.
Dated: June 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–16359 Filed 7–1–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: HHS–OS–0937–0166–
60D]
Agency Information Collection
Activities; Proposed Collection; Public
Comment Request
Office of Population Affairs,
Office of the Assistant Secretary for
Health, HHS.
ACTION: Notice.
AGENCY:
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
SUMMARY:
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38218
Federal Register / Vol. 80, No. 127 / Thursday, July 2, 2015 / Notices
Abstract: This is a request for
extension of a currently approved
collection for the disclosure and recordkeeping 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
respondents
Number of
responses per
respondent
Average
burden per
response
Type of respondent
Information collection
Citizens Seeking Sterilization
Information Disclosure for Sterilization
Consent Form.
Record-keeping for Sterilization Consent
Form.
100,000
1
1
100,000
100,000
1
15/60
25,000
.....................................................................
........................
........................
........................
125,000
Citizens Seeking Sterilization
Total ................................
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
asabaliauskas on DSK5VPTVN1PROD with NOTICES
National Cancer Institute Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections 552b(c)
(4) and 552b(c) (6), Title 5 U.S.C., as
amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
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Jkt 235001
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel, NCI
Program Project Meeting 1 (P01).
Date: October 8–9, 2015.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
North Bethesda, MD 20852.
Contact Person: Caterina Bianco, MD,
Ph.D., Scientific Review Officer, Research
Program Review Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 9609 Medical Center Drive,
Room 7W610, Bethesda, MD 20892–9750,
240–276–6459, biancoc@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: June 26, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–16213 Filed 7–1–15; 8:45 am]
BILLING CODE 4140–01–P
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Total hours
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflicts: Cardiovascular Sciences.
Date: July 20, 2015.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Sara Ahlgren, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, RM 4136,
Bethesda, MD 20892, 301–435–0904,
sara.ahlgren@nih.gov.
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]]>Agencies
[Federal Register Volume 80, Number 127 (Thursday, July 2, 2015)]
[Notices]
[Pages 38217-38218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16256]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
