Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request, 58738-58739 [2015-24702]
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58738
Federal Register / Vol. 80, No. 189 / Wednesday, September 30, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0007]
Biosimilar User Fee Act; Stakeholder
Meetings on Biosimilar User Fee Act of
2012 Reauthorization; Request for
Notification of Regulated Industry
Organization Intention To Participate
AGENCY:
Food and Drug Administration,
HHS.
Notice; request for notification
of participation.
ACTION:
The Food and Drug
Administration (FDA) is issuing this
notice to request that industry trade
associations, whose members include
drug companies currently engaged in
development or manufacture of
biosimilar biological products in the
U.S., or drug companies intending to
engage in these activities during the
period of FY 2018–2022, notify FDA of
their intent to participate in industry
stakeholder meetings in support of
timely reauthorization of the Biosimilar
User Fee Act of 2012 (BsUFA). The
statutory authority for BsUFA expires at
the end of September 2017. At that time,
new legislation will be required for FDA
to continue collecting user fees to fund
the biosimilar biological product review
process. The Federal Food, Drug, and
Cosmetic Act (the FD&C Act) requires
that FDA engage in negotiations with
regulated industry to develop
recommendations to present to Congress
with respect to the reauthorization of
BsUFA. The purpose of this request for
notification is to ensure that qualifying
industry organizations notify FDA of
their intention to participate in the
planned negotiation process.
DATES: Submit notification of intention
to participate by October 30, 2015.
ADDRESSES: Submit notification of
intention to participate in FDA-industry
user fee negotiations by email to
biosimilars@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Sandra Benton, Food and Drug
Administration, Center for Drug
Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6340,
Silver Spring, MD 20993, 301–796–
1042, FAX: 301–847–3529;
sandra.benton@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting that industry trade
associations, whose members include
drug companies currently engaged in
development or manufacture of
biosimilar biological products in the
U.S., or drug companies intending to
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:27 Sep 29, 2015
Jkt 235001
engage in these activities during the
period of FY 2018–2022, notify the
Agency of their intent to participate in
FDA-industry negotiations on the
reauthorization of BsUFA. BsUFA
authorizes FDA to collect fees from the
biosimilar biological product industry
for certain activities relating to
biosimilar biological product
development, for certain types of
applications and supplements for
approval of biosimilar biological
products, on establishments where
approved biosimilar biological products
are made, and on biosimilar biological
products after approval. BsUFA fees
finance critical and measurable aspects
of FDA’s biosimilar biological product
review program. The statutory authority
for BsUFA expires at the end of
September 2017. Without new
legislation, FDA will no longer be able
to collect user fees for future fiscal years
to fund the biosimilar biological product
review process. Section 744I(e) (21
U.S.C. 379j–53(e)) of the FD&C Act
requires that FDA, in developing
reauthorization recommendations to
present to Congress, consult with a
range of public and industry
stakeholders including representatives
from patient and consumer advocacy
groups,health care professionals,
scientific and academic experts, and the
regulated industry. FDA will initiate
this process on December 18, 2015, by
holding a public meeting at which these
key stakeholders and other members of
the public will be given an opportunity
to present their views on
reauthorization. The FD&C Act further
requires that after negotiations with the
regulated industry are concluded, FDA
shall present those recommendations for
public review and comment, and finally
transmit recommendations to Congress,
revised as necessary based on public
input, not later than January 15, 2017.
Consistent with FDA’s approach to
the Prescription Drug User Fee Act
(PDUFA) industry stakeholder meetings,
the BsUFA industry stakeholder
meetings will include industry trade
associations that represent biosimilar
biological product manufacturers rather
than individual companies.
Accordingly, FDA is issuing this
Federal Register notice to request that
industry associations, whose members
include drug companies currently
engaged in the development or
manufacture of biosimilar biological
products in the U.S, or drug companies
intending to engage in these activities
during the period of FY 2018–2022,
notify FDA of their intent to participate
in the industry stakeholder meetings on
BsUFA reauthorization.
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
Please notify FDA if you are a trade
association interested in participating in
this process by providing an email to
biosimilars@fda.hhs.gov by October 30,
2015. Your email should contain
complete contact information, including
name, title, organization affiliation,
address, email address, telephone
number, and notice of any special
accommodations required because of
disability. It is anticipated that the
negotiation process will begin within
the first quarter of calendar year 2016 in
order to ensure that FDA-industry
negotiations can be concluded and the
subsequent public consultation process
conducted in advance of the statutory
deadline in January 2017.
Dated: September 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–24815 Filed 9–29–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS–OS–0990–0281–
30D]
Agency Information Collection
Activities; Submission to OMB for
Review and Approval; Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, has submitted an
Information Collection Request (ICR),
described below, to the Office of
Management and Budget (OMB) for
review and approval. The ICR is for
revision of the approved information
collection assigned OMB control
number 0990–0281, scheduled to expire
on November 30, 2015. 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 October 30, 2015.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUMMARY:
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58739
Federal Register / Vol. 80, No. 189 / Wednesday, September 30, 2015 / Notices
When
submitting comments or requesting
information, please include the OMB
control number 0990–0281 for
reference.
Information Collection Request Title:
Prevention Communication Formative
Research—Revision—OMB No. 0990–
0281—Office of Disease Prevention and
Health Promotion.
Abstract: The Office of Disease
Prevention and Health Promotion’s
(ODPHP) focus includes developing and
disseminating prevention information to
the public. Changes in this request
include updated national hourly wage
and minor changes to data collection
activities and related burden hours in
order to meet the needs of the initiatives
mentioned below. This request builds
on previous formative research
approaches to place more emphasis on
Web-based data collection to allow
SUPPLEMENTARY INFORMATION:
greater geographical diversity among
respondents, to decrease respondent
burden, and to save government costs.
As a federal government agency, ODPHP
strives to be responsive to the needs of
America’s diverse audiences while
simultaneously serving all Americans
across a range of channels. To carry out
its prevention information efforts,
ODPHP is committed to conducting
formative and usability research to
provide guidance on the development
and implementation of its disease
prevention and health promotion
communication and education efforts.
This generic clearance request describes
data collection activities involving
methods such as: Individual interviews,
focus groups, Web-based surveys, card
sorting and various forms of usability
testing to establish a deeper
understanding of the interests and needs
of consumers and health professionals
for disease prevention and health
promotion information and tools.
The information collected will be
used by ODPHP to improve its
communication, products, and services
that support key office activities
including: Healthy People, Dietary
Guidelines for Americans, Physical
Activity Guidelines for Americans,
healthfinder.gov, and increasing health
care quality and patient safety. ODPHP
communicates through its Web sites
(www.healthfinder.gov,
www.HealthyPeople.gov,
www.health.gov) and through other
channels including social media, print
materials, interactive training modules,
and reports.
Likely Respondents: Respondents are
likely to be either consumers or health
professionals.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden/
response
(in hours)
Number of
responses/
respondent
Number of
respondents
Data collection task
Instrument/form name
In-depth interviews ......................................
Screener ..............................
Interview ..............................
Screener ..............................
Focus Group ........................
Screener ..............................
Survey ..................................
Screener ..............................
Card Sort .............................
Screener ..............................
135
45
240
80
6000
2000
180
60
360
1
1
1
1
1
1
1
1
1
Usability Test .......................
120
1
..............................................
........................
........................
Focus groups ...............................................
Web-based surveys .....................................
Card sorting .................................................
Usability and prototype testing of materials
(print and Web).
Total ......................................................
Terry S. Clark,
Asst Information Collection Clearance
Officer.
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.
[FR Doc. 2015–24702 Filed 9–29–15; 8:45 am]
BILLING CODE 4150–32–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
mstockstill on DSK4VPTVN1PROD with NOTICES
National Heart, Lung, and Blood
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
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18:27 Sep 29, 2015
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Name of Committee: Heart, Lung, and
Blood Initial Review Group; NHLBI
Mentored Clinical and Basic Science Review
Committee.
Date: October 22–23, 2015.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Westin Crystal City, 1800 Jefferson
Davis Highway, Arlington, VA 22202.
Contact Person: Keith A. Mintzer, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7186, Bethesda, MD 20892–7924, 301–594–
7947, mintzerk@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
Total response
burden
(in hours)
10/60
1
10/60
1.5
5/60
15/60
10/60
1
10/60
22.5
45
40
120
500
500
180
60
60
1
..........................
120
1,647.50
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: September 24, 2015.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–24690 Filed 9–29–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Complementary &
Integrative Health; 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.
E:\FR\FM\30SEN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 189 (Wednesday, September 30, 2015)]
[Notices]
[Pages 58738-58739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24702]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS-OS-0990-0281-30D]
Agency Information Collection Activities; Submission to OMB for
Review and Approval; Public Comment Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the Secretary (OS), Department of
Health and Human Services, has submitted an Information Collection
Request (ICR), described below, to the Office of Management and Budget
(OMB) for review and approval. The ICR is for revision of the approved
information collection assigned OMB control number 0990-0281, scheduled
to expire on November 30, 2015. 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 October 30,
2015.
ADDRESSES: Submit your comments to OIRA_submission@omb.eop.gov or via
facsimile to (202) 395-5806.
FOR FURTHER INFORMATION CONTACT: Information Collection Clearance
staff, Information.CollectionClearance@hhs.gov or (202) 690-6162.
[[Page 58739]]
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the OMB control number 0990-0281 for
reference.
Information Collection Request Title: Prevention Communication
Formative Research--Revision--OMB No. 0990-0281--Office of Disease
Prevention and Health Promotion.
Abstract: The Office of Disease Prevention and Health Promotion's
(ODPHP) focus includes developing and disseminating prevention
information to the public. Changes in this request include updated
national hourly wage and minor changes to data collection activities
and related burden hours in order to meet the needs of the initiatives
mentioned below. This request builds on previous formative research
approaches to place more emphasis on Web-based data collection to allow
greater geographical diversity among respondents, to decrease
respondent burden, and to save government costs. As a federal
government agency, ODPHP strives to be responsive to the needs of
America's diverse audiences while simultaneously serving all Americans
across a range of channels. To carry out its prevention information
efforts, ODPHP is committed to conducting formative and usability
research to provide guidance on the development and implementation of
its disease prevention and health promotion communication and education
efforts. This generic clearance request describes data collection
activities involving methods such as: Individual interviews, focus
groups, Web-based surveys, card sorting and various forms of usability
testing to establish a deeper understanding of the interests and needs
of consumers and health professionals for disease prevention and health
promotion information and tools.
The information collected will be used by ODPHP to improve its
communication, products, and services that support key office
activities including: Healthy People, Dietary Guidelines for Americans,
Physical Activity Guidelines for Americans, healthfinder.gov, and
increasing health care quality and patient safety. ODPHP communicates
through its Web sites (www.healthfinder.gov, www.HealthyPeople.gov,
www.health.gov) and through other channels including social media,
print materials, interactive training modules, and reports.
Likely Respondents: Respondents are likely to be either consumers
or health professionals.
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden/ Total response
Data collection task Instrument/form Number of responses/ response (in burden (in
name respondents respondent hours) hours)
----------------------------------------------------------------------------------------------------------------
In-depth interviews.......... Screener........ 135 1 10/60 22.5
Interview....... 45 1 1 45
Focus groups................. Screener........ 240 1 10/60 40
Focus Group..... 80 1 1.5 120
Web-based surveys............ Screener........ 6000 1 5/60 500
Survey.......... 2000 1 15/60 500
Card sorting................. Screener........ 180 1 10/60 180
Card Sort....... 60 1 1 60
Usability and prototype Screener........ 360 1 10/60 60
testing of materials (print
and Web).
Usability Test.. 120 1 1 120
----------------------------------------------------------------
Total.................... ................ .............. .............. ............... 1,647.50
----------------------------------------------------------------------------------------------------------------
Terry S. Clark,
Asst Information Collection Clearance Officer.
[FR Doc. 2015-24702 Filed 9-29-15; 8:45 am]
BILLING CODE 4150-32-P
