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]

Download as PDF 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: http:// 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