82_FR_36951 82 FR 36801 - 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

82 FR 36801 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 82, Issue 150 (August 7, 2017)

Page Range36801-36802
FR Document2017-16495

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.

Federal Register, Volume 82 Issue 150 (Monday, August 7, 2017) 
[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)]
[Notices]
[Pages 36801-36802]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-16495]


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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 [email protected] 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 [email protected] 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
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* 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

Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices 36801 TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued Number of Number of responses Total annual Hours per Total 21 CFR section or activity respondents per responses response hours respondent 202.1(j)(1)(iii); assuring that adverse information be pub- licized ................................................................................ 0 0 0 12 0 202.1(j)(4); voluntary submission of ad to FDA ................... 5 1 5 20 100 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 Average Number of disclosures Total annual Total 21 CFR section or activity burden per respondents per disclosures hours disclosure respondent CDER 202.1; ad prepared in accordance with part 202 ................ 394 105.3 41,494 400 16,597,600 202.1(j)(1); info. included re. fatalities or serious damage .. 1 1 1 40 40 CBER 202.1; ad prepared in accordance with part 202 ................ 47 63.4 2,984 400 1,193,600 202.1(j)(1); info. included re. fatalities or serious damage .. 0 0 0 40 0 CVM 202.1; ad prepared in accordance with part 202 ................ 25 36 900 400 360,000 202.1(j)(1); info. included re. fatalities or serious damage .. 0 0 0 40 0 Total .............................................................................. ........................ ........................ ........................ ........................ 18,151,240 1 There are no capital costs or operating and maintenance costs associated with this collection. Dated: August 2, 2017. review and approval. Comments Abstract: HRSA’s AIDS Drug Anna K. Abram, submitted during the first public review Assistance Program (ADAP) is funded Deputy Commissioner for Policy, Planning, of this ICR will be provided to OMB. through the Ryan White HIV/AIDS Legislation, and Analysis. OMB will accept further comments from Program (RWHAP), Part B, Title XXVI of [FR Doc. 2017–16607 Filed 8–4–17; 8:45 am] the public during the review and the Public Health Service Act, which BILLING CODE 4164–01–P approval period. provides grants to states and territories. DATES: Comments on this ICR should be The ADAP provides medications for the received no later than September 6, treatment of HIV. Program funds may DEPARTMENT OF HEALTH AND 2017. also be used to purchase health HUMAN SERVICES ADDRESSES: Submit your comments, insurance for eligible clients and for including the ICR Title, to the desk services that enhance access, adherence, Health Resources and Services and monitoring of HIV drug treatments. Administration officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by The following states, territories, and Agency Information Collection fax to 202–395–5806. Pacific Island jurisdictions are eligible Activities: Submission to OMB for FOR FURTHER INFORMATION CONTACT: To to apply for RWHAP ADAP funding: All Review and Approval; Public Comment request a copy of the clearance requests 50 states, the District of Columbia, the Request; Information Collection submitted to OMB for review, email the Commonwealth of Puerto Rico, the U.S. Request Title: AIDS Drug Assistance HRSA Information Collection Clearance Virgin Islands, Guam, American Samoa, Program Data Report, OMB No. 0915– Officer at paperwork@hrsa.gov or call the Commonwealth of the Northern 0345—Extension (301) 443–1984. Mariana Islands, the Republic of Palau, SUPPLEMENTARY INFORMATION: When the Federated States of Micronesia, and AGENCY: Health Resources and Services submitting comments or requesting the Republic of the Marshall Islands. As Administration (HRSA), Department of information, please include the part of the funding requirements, ADAP Health and Human Services (HHS). information request collection title for grant recipients submit reports mstockstill on DSK30JT082PROD with NOTICES ACTION: Notice reference, in compliance with Section concerning information on patients 3506(c)(2)(A) of the Paperwork served, eligibility requirements, SUMMARY: In compliance with the Reduction Act of 1995. pharmaceuticals prescribed, pricing and Paperwork Reduction Act of 1995, Information Collection Request Title: other sources of support to provide HIV HRSA has submitted an Information AIDS Drug Assistance Program Data medication treatment, cost data, and Collection Request (ICR) to the Office of Report OMB No. 0915–0345— coordination with Medicaid. The ADAP Management and Budget (OMB) for Extension. Data Report (ADR) will be submitted VerDate Sep<11>2014 18:14 Aug 04, 2017 Jkt 241001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 E:\FR\FM\07AUN1.SGM 07AUN1

36802 Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices annually and consists of a Grantee Human Services (HHS) to the Burden Statement: Burden in this Report and a client-level data file. HRSA appropriate committees of Congress. context means the time expended by is requesting an extension of the ADR The collection of recipient-level and persons to generate, maintain, retain, with minor revisions to patient/client client level data enables HRSA to more disclose or provide the information eligibility requirements, which will effectively respond to requests from the requested. This includes the time align data reporting with the Ryan Secretary of HHS. In addition, client- needed to review instructions; to White HIV/AIDS Services Report. level information is needed by HRSA to develop, acquire, install and utilize Specifically, within Client Variables in review program performance and inform technology and systems for the purpose the client-level data file: strategic planning. Client-level data is of collecting, validating and verifying • Deletion of variable ID 7, also needed to support the monitoring information, processing and ‘‘Transgender’’ of national goals to end the HIV maintaining information, and disclosing epidemic: Reduce new HIV infections; • Addition of ‘‘Transgender Male to and providing information; to train increase access to care and optimize Female’’, ‘‘Transgender Female to personnel and to be able to respond to health outcomes for people living with Male’’, and ‘‘Transgender Other’’ as a collection of information; to search HIV; reduce HIV-related health response options for variable ID 6, data sources; to complete and review disparities and health inequities; and ‘‘Gender’’ the collection of information; and to achieve a more coordinated national Need and Proposed Use of the response to the HIV epidemic. transmit or otherwise disclose the Information: The RWHAP requires the Likely Respondents: State ADAP grant information. The total annual burden submission of annual reports by the recipients of Ryan White HIV/AIDS hours estimated for this ICR are Secretary of Department of Health and Program Part B funding. summarized in the table below. TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS Average Number of Number of Total burden per Total burden Form name responses per respondents responses response hours respondent (in 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, FOR FURTHER INFORMATION CONTACT: For as to eligibility for, and amount of, Acting Director, Division of the Executive information about requirements for compensation. Secretariat. filing petitions, and the program in A petition may be filed with respect [FR Doc. 2017–16495 Filed 8–4–17; 8:45 am] general, contact Lisa L. Reyes, Acting to injuries, disabilities, illnesses, BILLING CODE 4165–15–P Clerk, United States Court of Federal conditions, and deaths resulting from Claims, 717 Madison Place NW., vaccines described in the Vaccine Injury Washington, DC 20005, (202) 357–6400. Table (the table) set forth at 42 CFR DEPARTMENT OF HEALTH AND For information on HRSA’s role in the 100.3. This Table lists for each covered HUMAN SERVICES program, contact the Director, National childhood vaccine the conditions that Vaccine Injury Compensation Program, may lead to compensation and, for each Health Resources and Services 5600 Fishers Lane, Rm. 08N146B, condition, the time period for Administration Rockville, MD 20857; (301) 443–6593, occurrence of the first symptom or or visit our Web site at: http:// manifestation of onset or of significant National Vaccine Injury Compensation aggravation after vaccine www.hrsa.gov/vaccinecompensation/ Program; List of Petitions Received administration. Compensation may also index.html. be awarded for conditions not listed in AGENCY: Health Resources and Services SUPPLEMENTARY INFORMATION: The the table and for conditions that are Administration (HRSA), Department of program provides a system of no-fault manifested outside the time periods Health and Human Services (HHS). compensation for certain individuals specified in the table, but only if the ACTION: Notice. who have been injured by specified petitioner shows that the condition was childhood vaccines. Subtitle 2 of Title caused by one of the listed vaccines. SUMMARY: HRSA is publishing this XXI of the PHS Act, 42 U.S.C. 300aa– Section 2112(b)(2) of the PHS Act, 42 notice of petitions received under the 10 et seq., provides that those seeking U.S.C. 300aa–12(b)(2), requires that National Vaccine Injury Compensation compensation are to file a petition with ‘‘[w]ithin 30 days after the Secretary Program (the program), as required by the U.S. Court of Federal Claims and to receives service of any petition filed the Public Health Service (PHS) Act, as serve a copy of the petition on the under section 2111 the Secretary shall amended. While the Secretary of HHS is Secretary of HHS, who is named as the publish notice of such petition in the mstockstill on DSK30JT082PROD with NOTICES named as the respondent in all respondent in each proceeding. The Federal Register.’’ Set forth below is a proceedings brought by the filing of Secretary has delegated this list of petitions received by HRSA on petitions for compensation under the responsibility under the Program to June 1, 2017, through June 30, 2017. Program, the United States Court of HRSA. The Court is directed by statute This list provides the name of Federal Claims is charged by statute to appoint special masters who take petitioner, city and state of vaccination with responsibility for considering and evidence, conduct hearings as (if unknown then city and state of acting upon the petitions. appropriate, and make initial decisions person or attorney filing claim), and VerDate Sep<11>2014 18:14 Aug 04, 2017 Jkt 241001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 E:\FR\FM\07AUN1.SGM 07AUN1


Document Created: 2017-08-05 02:59:44
Document Modified: 2017-08-05 02:59:44
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice
DatesComments on this ICR should be received no later than September 6, 2017.
ContactTo request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at [email protected] or call (301) 443- 1984.
FR Citation82 FR 36801 
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