Agency Information Collection Request. 30-Day Public Comment Request, 29525-29526 [2019-13323]
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jbell on DSK3GLQ082PROD with NOTICES
Federal Register / Vol. 84, No. 121 / Monday, June 24, 2019 / Notices
Monique Hill, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 6338,
Silver Spring, MD 20993–0002, 240–
402–5771, serina.hunter-thomas@
fda.hhs.gov or 301–796–4620,
monique.hill@fda.hhs.gov respectively,
or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area). A notice in the Federal Register
about last minute modifications that
impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the Agency’s
website at https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting. For those
unable to attend in person, the meeting
will also be available via Webcast. The
Webcast will be available at the
following link: https://
collaboration.fda.gov/apac091319/.
SUPPLEMENTARY INFORMATION:
Agenda: On September 13, 2019, the
Center for Biologics Evaluation and
Research’s (CBER) Vaccines and Related
Biological Products Advisory
Committee (VRBPAC) will meet in open
session to discuss and make
recommendations on the safety and
efficacy of Peanut [Arachis hypogaea]
Allergen Powder manufactured by
Aimmune Therapeutics, Inc, indicated
for treatment to reduce the risk of
anaphylaxis after accidental exposure to
peanut in patients aged 4 to 17 years
with a confirmed diagnosis of peanut
allergy.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s website after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: On September 13, 2019,
from 8:30 a.m. to 4:30 p.m., the meeting
is open to the public. Interested persons
may present data, information, or views,
orally or in writing, on issues pending
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before the committee. Written
submissions may be made to the contact
person on or before September 6, 2019.
On September 13, 2019, oral
presentations from the public will be
scheduled between approximately 1
p.m. to 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before August
29, 2019. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by August 30, 2019.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Serina HunterThomas at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at:
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: June 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–13354 Filed 6–21–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0945–0002]
Agency Information Collection
Request. 30-Day Public Comment
Request
AGENCY:
PO 00000
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
SUMMARY:
Comments on the ICR must be
received on or before July 24, 2019.
DATES:
Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
0990–New–30D and project title for
reference.
Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (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.
Title of the Collection: Health
Information Privacy and Civil Rights/
Conscience and Religious Freedom
Discrimination Complaint.
Type of Collection: Revision.
OMB No. 0945–0002.
Abstract: The Office for Civil Rights is
seeking a revision on an approval for a
3-year clearance on a previous
collection. Individuals may file written
or electronic complaints with the Office
for Civil Rights when they believe they
have been discriminated against by
programs or entities that receive Federal
financial assistance from the Health and
Human Service or if they believe that
their right to the privacy of protected
health information freedom has been
violated. Annual Number of
Respondents frequency of submission is
record keeping and reporting on
occasion.
SUPPLEMENTARY INFORMATION:
Office of the Secretary, HHS.
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Sfmt 4703
29525
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Federal Register / Vol. 84, No. 121 / Monday, June 24, 2019 / Notices
ESTIMATED ANNUALIZED BURDEN TABLE
Written forms/
electronic forms
Type of
respondent
Civil Rights/Conscience Religious Freedom Discrimination Complaint.
Health Information Privacy Complaint .....
Total .................................................
Individuals
for-profit
Individuals
for-profit
[FR Doc. 2019–13323 Filed 6–21–19; 8:45 am]
BILLING CODE 4153–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0390]
Agency Information Collection
Request. 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before July 24, 2019.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
0990–New–30D and project title for
reference.
SUMMARY:
Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (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.
jbell on DSK3GLQ082PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
16:50 Jun 21, 2019
Jkt 247001
or households, Notinstitutions.
or households, Notinstitutions.
....................................................
Terry Clark,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
Number of
responses per
respondent
Number of
respondents
Frm 00034
Fmt 4703
Total
burden hours
8433
1
45/60
6325
25,299
1
45/60
18,974
........................
........................
........................
25,299
Title of the Collection: Challenge and
Prize Competition Solicitations.
Type of Collection: Reinstatement w/
chg.
OMB No. 0990–0390—Office of the
Chief Technology Officer (CTO)
Abstract: The Office of the Secretary
(OS), Department of Health & Human
Services (HHS) requests that the Office
of Management and Budget (OMB)
approve a request for a generic clearance
approval of the information collected for
challenge and prize competition
solicitations.
Challenges and prize competitions
enable HHS to tap into the expertise and
creativity of the public in new ways as
well as extend awareness of HHS
programs and priorities. Within HHS,
the Office of the Chief Technology
Officer (CTO) has taken lead
responsibility in coordinating
challenges and prize competitions and
implementing policies regarding the use
of these tools. HHS’s goal is to engage
a broader number of stakeholders who
are inspired to work on some of our
most pressing health issues, thus
supporting a new ecosystem of
scientists, developers, and
entrepreneurs who can continue to
innovate for public health.
The generic clearance is necessary for
HHS to launch several challenges or
prize competitions annually in a short
turnaround. The information collected
for these challenges and prize
competitions will generally include the
submitter’s or other contact person’s
first and last name, organizational
affiliation and role in the organization
(for identification purposes); email
address or other contact information (to
follow up if the submitted solution is
selected as finalist or winner); street
address (to confirm that the submitter or
affiliated organization is located in the
United States, for eligibility purposes);
information confirming whether the
submitter’s age is 13 years or older (to
ensure compliance with the Children’s
Online Privacy Protection Act of 1998
(15 U.S.C. 6501–6505) (COPPA) or 18
years or older (to ensure necessary
consents are obtained); and a narrative
PO 00000
Average
burden
hours per
response
Sfmt 4703
description of the solution. HHS may
also request information indicating the
submitter’s technical background,
educational level, ethnicity, age range,
gender, and race (to evaluate entrants’
diversity and backgrounds), how the
submitter learned about the challenge or
prize competition and what the
submitter currently understands about
the HHS agency hosting the challenge or
prize competition (to gauge the effect of
the challenge or prize competition on
increasing public awareness of HHS
programs and priorities, and generally
to enable HHS to improve its outreach
strategies to ensure a diverse and broad
innovator constituency is fostered
through the use of challenges and prize
competitions). Finally, HHS may ask for
additional information tailored to the
particular challenge or prize
competition through structured
questions. This information will enable
HHS to more effectively create and
administer challenges and prize
competitions.
Upon entry or during the judging
process, solvers under the age of 18 may
be asked to confirm parental consent,
thereby requiring solvers under 18 to
have a parent or guardian signature in
a format outlined in the specific criteria
of each challenge or prize competition
in order to qualify for the contest. To
protect online privacy of minors,
birthdate may be required by the
website host to ensure the challenge
platform meets the requirements of
COPPA. Eligibility to win a cash prize
will be outlined in the specific criteria
of each contest and will only apply to
U.S. citizens, permanent residents, or
private entities incorporated in and
maintaining a primary place of business
in the U.S. To administer the cash prize,
HHS will need to collect additional
relevant payment information— such as
Social Security Number and/or
Taxpayer ID and information regarding
the winners’ financial institutions—in
order to comply with financial
accounting processes.
Likely Respondents: Likely
respondents include individuals,
businesses, and state and local
E:\FR\FM\24JNN1.SGM
24JNN1
]]>Agencies
[Federal Register Volume 84, Number 121 (Monday, June 24, 2019)]
[Notices]
[Pages 29525-29526]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13323]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0945-0002]
Agency Information Collection Request. 30-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, the Office of the Secretary (OS), Department of Health and
Human Services, is publishing the following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before July 24, 2019.
ADDRESSES: Submit your comments to [email protected] or via
facsimile to (202) 395-5806.
FOR FURTHER INFORMATION CONTACT: Sherrette Funn, [email protected]
or (202) 795-7714. When submitting comments or requesting information,
please include the document identifier 0990-New-30D and project title
for reference.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (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.
Title of the Collection: Health Information Privacy and Civil
Rights/Conscience and Religious Freedom Discrimination Complaint.
Type of Collection: Revision.
OMB No. 0945-0002.
Abstract: The Office for Civil Rights is seeking a revision on an
approval for a 3-year clearance on a previous collection. Individuals
may file written or electronic complaints with the Office for Civil
Rights when they believe they have been discriminated against by
programs or entities that receive Federal financial assistance from the
Health and Human Service or if they believe that their right to the
privacy of protected health information freedom has been violated.
Annual Number of Respondents frequency of submission is record keeping
and reporting on occasion.
[[Page 29526]]
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Number of Average
Written forms/ electronic Type of Number of responses per burden hours Total burden
forms respondent respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
Civil Rights/Conscience Individuals or 8433 1 45/60 6325
Religious Freedom households, Not-
Discrimination Complaint. for-profit
institutions.
Health Information Privacy Individuals or 25,299 1 45/60 18,974
Complaint. households, Not-
for-profit
institutions.
---------------------------------------------------------------------------------
Total..................... ................ .............. .............. .............. 25,299
----------------------------------------------------------------------------------------------------------------
Terry Clark,
Office of the Secretary, Paperwork Reduction Act Reports Clearance
Officer.
[FR Doc. 2019-13323 Filed 6-21-19; 8:45 am]
BILLING CODE 4153-01-P
