Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: AIDS Drug Assistance Program Data Report, OMB No. 0915-0345-Extension, 36801-36802 [2017-16495]
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36801
Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
responses
per
respondent
Number of
respondents
21 CFR section or activity
Total annual
responses
Hours per
response
Total
hours
202.1(j)(1)(iii); assuring that adverse information be publicized ................................................................................
202.1(j)(4); voluntary submission of ad to FDA ...................
0
5
0
1
0
5
12
20
0
100
Total ..............................................................................
........................
........................
........................
........................
11,466
1 There
are no capital costs or operating and maintenance costs associated with this collection.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR section or activity
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total
hours
CDER
202.1; ad prepared in accordance with part 202 ................
202.1(j)(1); info. included re. fatalities or serious damage ..
394
1
105.3
1
41,494
1
400
40
16,597,600
40
63.4
0
2,984
0
400
40
1,193,600
0
CBER
202.1; ad prepared in accordance with part 202 ................
202.1(j)(1); info. included re. fatalities or serious damage ..
47
0
CVM
202.1; ad prepared in accordance with part 202 ................
202.1(j)(1); info. included re. fatalities or serious damage ..
25
0
36
0
900
0
400
40
360,000
0
Total ..............................................................................
........................
........................
........................
........................
18,151,240
1 There
are no capital costs or operating and maintenance costs associated with this collection.
Dated: August 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–16607 Filed 8–4–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Information Collection
Request Title: AIDS Drug Assistance
Program Data Report, OMB No. 0915–
0345—Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice
mstockstill on DSK30JT082PROD with NOTICES
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
SUMMARY:
VerDate Sep<11>2014
18:14 Aug 04, 2017
Jkt 241001
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than September 6,
2017.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference, in compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995.
Information Collection Request Title:
AIDS Drug Assistance Program Data
Report OMB No. 0915–0345—
Extension.
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
Abstract: HRSA’s AIDS Drug
Assistance Program (ADAP) is funded
through the Ryan White HIV/AIDS
Program (RWHAP), Part B, Title XXVI of
the Public Health Service Act, which
provides grants to states and territories.
The ADAP provides medications for the
treatment of HIV. Program funds may
also be used to purchase health
insurance for eligible clients and for
services that enhance access, adherence,
and monitoring of HIV drug treatments.
The following states, territories, and
Pacific Island jurisdictions are eligible
to apply for RWHAP ADAP funding: All
50 states, the District of Columbia, the
Commonwealth of Puerto Rico, the U.S.
Virgin Islands, Guam, American Samoa,
the Commonwealth of the Northern
Mariana Islands, the Republic of Palau,
the Federated States of Micronesia, and
the Republic of the Marshall Islands. As
part of the funding requirements, ADAP
grant recipients submit reports
concerning information on patients
served, eligibility requirements,
pharmaceuticals prescribed, pricing and
other sources of support to provide HIV
medication treatment, cost data, and
coordination with Medicaid. The ADAP
Data Report (ADR) will be submitted
E:\FR\FM\07AUN1.SGM
07AUN1
36802
Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices
annually and consists of a Grantee
Report and a client-level data file. HRSA
is requesting an extension of the ADR
with minor revisions to patient/client
eligibility requirements, which will
align data reporting with the Ryan
White HIV/AIDS Services Report.
Specifically, within Client Variables in
the client-level data file:
• Deletion of variable ID 7,
‘‘Transgender’’
• Addition of ‘‘Transgender Male to
Female’’, ‘‘Transgender Female to
Male’’, and ‘‘Transgender Other’’ as
response options for variable ID 6,
‘‘Gender’’
Need and Proposed Use of the
Information: The RWHAP requires the
submission of annual reports by the
Secretary of Department of Health and
Human Services (HHS) to the
appropriate committees of Congress.
The collection of recipient-level and
client level data enables HRSA to more
effectively respond to requests from the
Secretary of HHS. In addition, clientlevel information is needed by HRSA to
review program performance and inform
strategic planning. Client-level data is
also needed to support the monitoring
of national goals to end the HIV
epidemic: Reduce new HIV infections;
increase access to care and optimize
health outcomes for people living with
HIV; reduce HIV-related health
disparities and health inequities; and
achieve a more coordinated national
response to the HIV epidemic.
Likely Respondents: State ADAP grant
recipients of Ryan White HIV/AIDS
Program Part B funding.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Grantee Report ....................................................................
Client-level File ....................................................................
54
54
1
1
54
54
6
81
324
4,374
Total ..............................................................................
* 54
........................
54
........................
4,698
* The same respondents complete the Grantee Report and the Client-level Report.
Amy McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2017–16495 Filed 8–4–17; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
AGENCY:
ACTION:
Notice.
HRSA is publishing this
notice of petitions received under the
National Vaccine Injury Compensation
Program (the program), as required by
the Public Health Service (PHS) Act, as
amended. While the Secretary of HHS is
named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
mstockstill on DSK30JT082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:14 Aug 04, 2017
Jkt 241001
For
information about requirements for
filing petitions, and the program in
general, contact Lisa L. Reyes, Acting
Clerk, United States Court of Federal
Claims, 717 Madison Place NW.,
Washington, DC 20005, (202) 357–6400.
For information on HRSA’s role in the
program, contact the Director, National
Vaccine Injury Compensation Program,
5600 Fishers Lane, Rm. 08N146B,
Rockville, MD 20857; (301) 443–6593,
or visit our Web site at: https://
www.hrsa.gov/vaccinecompensation/
index.html.
FOR FURTHER INFORMATION CONTACT:
The
program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
compensation are to file a petition with
the U.S. Court of Federal Claims and to
serve a copy of the petition on the
Secretary of HHS, who is named as the
respondent in each proceeding. The
Secretary has delegated this
responsibility under the Program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
appropriate, and make initial decisions
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
vaccines described in the Vaccine Injury
Table (the table) set forth at 42 CFR
100.3. This Table lists for each covered
childhood vaccine the conditions that
may lead to compensation and, for each
condition, the time period for
occurrence of the first symptom or
manifestation of onset or of significant
aggravation after vaccine
administration. Compensation may also
be awarded for conditions not listed in
the table and for conditions that are
manifested outside the time periods
specified in the table, but only if the
petitioner shows that the condition was
caused by one of the listed vaccines.
Section 2112(b)(2) of the PHS Act, 42
U.S.C. 300aa–12(b)(2), requires that
‘‘[w]ithin 30 days after the Secretary
receives service of any petition filed
under section 2111 the Secretary shall
publish notice of such petition in the
Federal Register.’’ Set forth below is a
list of petitions received by HRSA on
June 1, 2017, through June 30, 2017.
This list provides the name of
petitioner, city and state of vaccination
(if unknown then city and state of
person or attorney filing claim), and
E:\FR\FM\07AUN1.SGM
07AUN1
Agencies
[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)]
[Notices]
[Pages 36801-36802]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16495]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; Information Collection
Request Title: AIDS Drug Assistance Program Data Report, OMB No. 0915-
0345--Extension
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act of 1995, HRSA
has submitted an Information Collection Request (ICR) to the Office of
Management and Budget (OMB) for review and approval. Comments submitted
during the first public review of this ICR will be provided to OMB. OMB
will accept further comments from the public during the review and
approval period.
DATES: Comments on this ICR should be received no later than September
6, 2017.
ADDRESSES: Submit your comments, including the ICR Title, to the desk
officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by
fax to 202-395-5806.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email the HRSA Information
Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443-
1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference, in compliance with Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995.
Information Collection Request Title: AIDS Drug Assistance Program
Data Report OMB No. 0915-0345--Extension.
Abstract: HRSA's AIDS Drug Assistance Program (ADAP) is funded
through the Ryan White HIV/AIDS Program (RWHAP), Part B, Title XXVI of
the Public Health Service Act, which provides grants to states and
territories. The ADAP provides medications for the treatment of HIV.
Program funds may also be used to purchase health insurance for
eligible clients and for services that enhance access, adherence, and
monitoring of HIV drug treatments. The following states, territories,
and Pacific Island jurisdictions are eligible to apply for RWHAP ADAP
funding: All 50 states, the District of Columbia, the Commonwealth of
Puerto Rico, the U.S. Virgin Islands, Guam, American Samoa, the
Commonwealth of the Northern Mariana Islands, the Republic of Palau,
the Federated States of Micronesia, and the Republic of the Marshall
Islands. As part of the funding requirements, ADAP grant recipients
submit reports concerning information on patients served, eligibility
requirements, pharmaceuticals prescribed, pricing and other sources of
support to provide HIV medication treatment, cost data, and
coordination with Medicaid. The ADAP Data Report (ADR) will be
submitted
[[Page 36802]]
annually and consists of a Grantee Report and a client-level data file.
HRSA is requesting an extension of the ADR with minor revisions to
patient/client eligibility requirements, which will align data
reporting with the Ryan White HIV/AIDS Services Report. Specifically,
within Client Variables in the client-level data file:
Deletion of variable ID 7, ``Transgender''
Addition of ``Transgender Male to Female'', ``Transgender
Female to Male'', and ``Transgender Other'' as response options for
variable ID 6, ``Gender''
Need and Proposed Use of the Information: The RWHAP requires the
submission of annual reports by the Secretary of Department of Health
and Human Services (HHS) to the appropriate committees of Congress. The
collection of recipient-level and client level data enables HRSA to
more effectively respond to requests from the Secretary of HHS. In
addition, client-level information is needed by HRSA to review program
performance and inform strategic planning. Client-level data is also
needed to support the monitoring of national goals to end the HIV
epidemic: Reduce new HIV infections; increase access to care and
optimize health outcomes for people living with HIV; reduce HIV-related
health disparities and health inequities; and achieve a more
coordinated national response to the HIV epidemic.
Likely Respondents: State ADAP grant recipients of Ryan White HIV/
AIDS Program Part B funding.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Grantee Report.................. 54 1 54 6 324
Client-level File............... 54 1 54 81 4,374
-------------------------------------------------------------------------------
Total....................... * 54 .............. 54 .............. 4,698
----------------------------------------------------------------------------------------------------------------
* The same respondents complete the Grantee Report and the Client-level Report.
Amy McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2017-16495 Filed 8-4-17; 8:45 am]
BILLING CODE 4165-15-P