Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request, 41404-41405 [2013-16599]

Download as PDF 41404 Federal Register / Vol. 78, No. 132 / Wednesday, July 10, 2013 / Notices to be retained for at least 10 years beyond the date of transplantation if known, distribution, disposition, or expiration of the tissue, whichever is the latest. Section 1270.35(a) through (d) requires specific records to be maintained to document the following: (1) The results and interpretation of all required infectious disease tests; (2) information on the identity and relevant medical records of the donor; (3) the receipt and/or distribution of human tissue, and (4) the destruction or other disposition of human tissue. Respondents to this collection of information are manufacturers of human tissue intended for transplantation. Based on information from the Center for Biologics Evaluation and Research’s (CBER’s) database system, FDA estimates that there are approximately 281 tissue establishments, of which 185 are conventional tissue banks and 96 are eye tissue banks. Based on information provided by industry, there are an estimated total of 1,959,270 conventional tissue products and 82,741 eye tissue products recovered per year with an average of 25 percent of the tissue discarded due to unsuitability for transplant. In addition, there are an estimated 73,075 donors of conventional tissue and 49,026 donors of eye tissue each year. Accredited members of the American Association of Tissue Banks (AATB) and Eye Bank Association of America (EBAA) adhere to standards of those organizations that are comparable to the recordkeeping requirements in part 1270. Based on information provided by CBER’s database system, 90 percent of the conventional tissue banks are members of AATB (185 × 90 percent = 166), and 85 percent of eye tissue banks are members of EBAA (96 × 85 percent = 82). Therefore, recordkeeping by these 248 establishments (166 + 82 = 248) is excluded from the burden estimates as usual and customary business activities (5 CFR 1320.3(b)(2)). The recordkeeping burden, thus, is estimated for the remaining 33 establishments, which is 12 percent of all establishments (281 ¥ 248 = 33, or 33/281 = 12 percent). FDA assumes that all current tissue establishments have developed written procedures in compliance with part 1270. Therefore, their information collection burden is for the general review and update of written procedures estimated to take an annual average of 24 hours, and for the recording and justifying of any deviations from the written procedures under § 1270.31(a) and (b), estimated to take an annual average of 1 hour. The information collection burden for maintaining records concurrently with the performance of each significant screening and testing step and for retaining records for 10 years under § 1270.33(a), (f), and (h) include documenting the results and interpretation of all required infectious disease tests and results and the identity and relevant medical records of the donor required under § 1270.35(a) and (b). Therefore, the burden under these provisions is calculated together in table 1 of this document. The recordkeeping estimates for the number of total annual records and hours per record are based on information provided by industry and FDA experience. FDA estimates the burden of this information collection as follows: TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of records per recordkeeper Number of recordkeepers 21 CFR Section 1270.31(a), (b), (c), and (d) 2 ....... 1270.31(a) and 1270.31(b) 3 ........ 1270.33(a), (f), and (h), and 1270.35(a) and (b) ................... 1270.35(c) .................................... 1270.35(d) .................................... Total annual records Average burden per recordkeeping Total hours 33 33 1 2 33 66 24 1 792 66 33 33 33 7,869.48 14,850.96 1,856.36 259,693 490,082 61,260 1 1 1 259,693 490,082 61,260 Total ...................................... 811,893 1 There are no capital costs or operating and maintenance costs associated with this collection of information. and update of standard operating procedures (SOPs). 3 Documentation of deviations from SOPs. 2 Review Dated: July 3, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–16556 Filed 7–9–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES TKELLEY on DSK3SPTVN1PROD with NOTICES Health Resources and Services Administration Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: VerDate Mar<15>2010 17:42 Jul 09, 2013 Jkt 229001 In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (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 within 30 days of this notice. ADDRESSES: Submit your comments, including the Information Collection Request Title, to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to 202–395–5806. SUMMARY: PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 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: Information Collection Request Title: Evaluating the Impact of 1115 Medicaid Waivers on Ryan White HIV/AIDS Program and Its Clients and Providers OMB No. 0915–xxxx—NEW Abstract: Section 1115 of the Social Security Act allows states to develop, test, and implement new approaches to providing Medicaid coverage outside of federal program rules. Leading up to full implementation of the Affordable Care Act, states have begun to use Section 1115 Medicaid demonstration waivers as a ‘‘bridge’’ to 2014. This project will FOR FURTHER INFORMATION CONTACT: E:\FR\FM\10JYN1.SGM 10JYN1 41405 Federal Register / Vol. 78, No. 132 / Wednesday, July 10, 2013 / Notices examine 1115 Medicaid waivers that have expanded eligibility to include specifically people living with HIV/ AIDS (PLWH) who are not otherwise eligible for Medicaid services. Since 1990, the Ryan White HIV/AIDS Program (RWHAP) has provided funding for primary care, medications, and support services for PLWH, helping fill the health care and service gap for those who are uninsured or ineligible for Medicaid. As part of this project, case studies will be conducted in eight states that have implemented 1115 Medicaid waivers to expand Medicaid eligibility for PLWH. The case studies will include site visits and discussions with the state Medicaid programs and with RWHAP grantees and service providers to examine the waivers and their impact on PLWH. In addition, the studies will explore whether and how the 1115 Medicaid waivers have helped states and RWHAP grantees and providers prepare for implementation of the Affordable Care Act, including providing insights into Medicaid expansion. Need and Proposed Use of the Information: Given the important role of the RWHAP and Medicaid in meeting the health care needs of PLWH, there is a need to understand better, how Medicaid expansion and the 1115 Medicaid waivers will affect the RWHAP and how the waivers have prepared states for implementation of the Affordable Care Act. Likely Respondents: Data will be collected through qualitative interviews, guided by discussion tools with questions tailored for four specific groups of individuals from: (1) State Medicaid agencies; (2) RWHAP Part B grantees and service providers; (3) RWHAP Part A grantees and service providers; and (4) and RWHAP White Part C grantees and clinical providers. 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 Qualitative Interview Data Collection Tool for State Medicaid Agency Groups ........................................................ Qualitative Interview Data Collection Tool for Ryan White Part A Administrators and Members of Planning Councils .................................................................................... Qualitative Interview Data Collection Tool for Ryan White Part A Administrators and Members of Planning Councils .................................................................................... Qualitative Interview Data Collection Tool for Ryan White Part B and ADAP (AIDS Directors, Part B Coordinators and ADAP Coordinators) .................................................. Qualitative Interview Data Collection Tool for Ryan White Clinical Providers (RW Part C Grantees in clinical settings or Similar Clinical Care Providers) .......................... [FR Doc. 2013–16599 Filed 7–9–13; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES TKELLEY on DSK3SPTVN1PROD with NOTICES Health Resources and Services Administration Agency Information Collection Activities; Proposed Collection; Public Comment Request Health Resources and Services Administration, HHS. AGENCY: ACTION: Notice. VerDate Mar<15>2010 17:42 Jul 09, 2013 Jkt 229001 Total burden hours 40 2 80 64 1 64 2 128 16 1 16 2 32 80 1 80 2 160 80 1 80 2 160 280 ........................ ........................ ........................ 560 In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this Information Collection Request must be received within 60 days of this notice. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Frm 00054 Average burden per response (in hours) 1 SUMMARY: PO 00000 Total responses 40 Total .............................................................................. Dated: July 3, 2013. Bahar Niakan, Director, Division of Policy and Information Coordination. Number of responses per respondent Fmt 4703 Sfmt 4703 Officer, Room 10–29, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Information Collection Clearance Officer at (301) 443–1984. FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting information, please include the information request collection title for reference. SUPPLEMENTARY INFORMATION: E:\FR\FM\10JYN1.SGM 10JYN1

Agencies

[Federal Register Volume 78, Number 132 (Wednesday, July 10, 2013)]
[Notices]
[Pages 41404-41405]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16599]


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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

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the Health Resources and Services Administration 
(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 within 30 days of this 
notice.

ADDRESSES: Submit your comments, including the Information Collection 
Request 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: Information Collection Request Title: 
Evaluating the Impact of 1115 Medicaid Waivers on Ryan White HIV/AIDS 
Program and Its Clients and Providers OMB No. 0915-xxxx--NEW
    Abstract: Section 1115 of the Social Security Act allows states to 
develop, test, and implement new approaches to providing Medicaid 
coverage outside of federal program rules. Leading up to full 
implementation of the Affordable Care Act, states have begun to use 
Section 1115 Medicaid demonstration waivers as a ``bridge'' to 2014. 
This project will

[[Page 41405]]

examine 1115 Medicaid waivers that have expanded eligibility to include 
specifically people living with HIV/AIDS (PLWH) who are not otherwise 
eligible for Medicaid services. Since 1990, the Ryan White HIV/AIDS 
Program (RWHAP) has provided funding for primary care, medications, and 
support services for PLWH, helping fill the health care and service gap 
for those who are uninsured or ineligible for Medicaid.
    As part of this project, case studies will be conducted in eight 
states that have implemented 1115 Medicaid waivers to expand Medicaid 
eligibility for PLWH. The case studies will include site visits and 
discussions with the state Medicaid programs and with RWHAP grantees 
and service providers to examine the waivers and their impact on PLWH. 
In addition, the studies will explore whether and how the 1115 Medicaid 
waivers have helped states and RWHAP grantees and providers prepare for 
implementation of the Affordable Care Act, including providing insights 
into Medicaid expansion.
    Need and Proposed Use of the Information: Given the important role 
of the RWHAP and Medicaid in meeting the health care needs of PLWH, 
there is a need to understand better, how Medicaid expansion and the 
1115 Medicaid waivers will affect the RWHAP and how the waivers have 
prepared states for implementation of the Affordable Care Act.
    Likely Respondents: Data will be collected through qualitative 
interviews, guided by discussion tools with questions tailored for four 
specific groups of individuals from: (1) State Medicaid agencies; (2) 
RWHAP Part B grantees and service providers; (3) RWHAP Part A grantees 
and service providers; and (4) and RWHAP White Part C grantees and 
clinical providers.
    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
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of         Total        burden per     Total burden
            Form name               respondents    responses per     responses     response  (in       hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Qualitative Interview Data                    40               1              40               2              80
 Collection Tool for State
 Medicaid Agency Groups.........
Qualitative Interview Data                    64               1              64               2             128
 Collection Tool for Ryan White
 Part A Administrators and
 Members of Planning Councils...
Qualitative Interview Data                    16               1              16               2              32
 Collection Tool for Ryan White
 Part A Administrators and
 Members of Planning Councils...
Qualitative Interview Data                    80               1              80               2             160
 Collection Tool for Ryan White
 Part B and ADAP (AIDS
 Directors, Part B Coordinators
 and ADAP Coordinators).........
Qualitative Interview Data                    80               1              80               2             160
 Collection Tool for Ryan White
 Clinical Providers (RW Part C
 Grantees in clinical settings
 or Similar Clinical Care
 Providers).....................
                                 -------------------------------------------------------------------------------
    Total.......................             280  ..............  ..............  ..............             560
----------------------------------------------------------------------------------------------------------------


    Dated: July 3, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-16599 Filed 7-9-13; 8:45 am]
BILLING CODE 4165-15-P