Agency Information Collection Activities: Submission for OMB Review; Comment Request, 37249-37250 [E7-13170]

Download as PDF 37249 Federal Register / Vol. 72, No. 130 / Monday, July 9, 2007 / Notices facilities for construction-related activities and/or capital equipment purchases. Awarded facilities are required to provide a periodic (quarterly for construction-related projects, annually for equipment only projects) update of the status of the funded project until it is completed. The monitoring period averages about 3 years, although some projects take up to 5 years to complete. The information collected from these updates is vital to An electronic form has been developed for progress reporting for the HCOF program. This form will provide awardees access to directly input the required status update information in a timely, consistent, and uniform manner. The electronic form will minimize burden to respondents and will inform respondents when there are missing data elements prior to submission. The estimate of burden for the form is as follows: program management staff to determine whether projects are progressing according to the established timeframes, meeting deadlines established in the Notice of Grant Award (NGA), and drawing down funds appropriately. The data collected from the updates is also shared with the Division of Grants Management Operations (DGMO) and the Division of Engineering Services (DES) for their assistance in the overall evaluation of each project’s progress. Number of respondents Project type Response per respondent Total responses Hours per response Total burden hours Construction-Related ........................................................... Equipment Only ................................................................... 395 523 4 1 1,580 523 .5 .5 790 262 Total .............................................................................. 918 ........................ 2,103 ........................ 1,052 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to: Karen Matsuoka, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503. Dated: June 28, 2007. Caroline Lewis, Associate Administrator for Management. [FR Doc. E7–13169 Filed 7–6–07; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 information is used to indicate the disease severity of transplant candidates, to monitor compliance of member organizations with OPTN rules and requirements, and to report periodically on the clinical and scientific status of organ donation and transplantation in this country. Data are used to develop transplant, donation and allocation policies, to determine if institutional members are complying with policy, to determine member specific performance, to ensure patient safety when no alternative sources of data exist and to fulfill the requirements of the OPTN Final Rule. The practical utility of the data collection is further enhanced by requirements that the OPTN data must be made available, consistent with applicable laws, for use by OPTN members, the Scientific Registry of Transplant Recipients, the Department of Health and Human Services, and others for evaluation, research, patient information, and other important purposes. Revisions in the 26 data collection forms are intended to implement approved reduction in data collection for candidates and recipients, to provide additional information specific to pediatric patients, and to clarify existing questions. U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301) 443–1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: Data System for Organ Procurement and Transplantation Network and Associated Forms (OMB No. 0915– 0157)—Revision Section 372 of the Public Health Service (PHS) Act requires that the Secretary, by contract, provide for the establishment and operation of an Organ Procurement and Transplantation Network (OPTN). The OPTN, among other responsibilities, operates and maintains a national waiting list of individuals requiring organ transplants, maintains a computerized system for matching donor organs with transplant candidates on the waiting list, and operates a 24-hour system to facilitate matching organs with individuals included in the list. Data for the OPTN data system are collected from transplant hospitals, organ procurement organizations, and tissue-typing laboratories. The ESTIMATES OF ANNUALIZED HOUR BURDEN Number of respondents rwilkins on PROD1PC63 with NOTICES Form Deceased Donor Registration .............................................. Death referral data ............................................................... Living Donor Registration .................................................... Living Donor Follow-up ........................................................ Donor Histocompatibility ...................................................... Recipient Histocompatibility ................................................. Heart Candidate Registration .............................................. Lung Candidate Registration ............................................... VerDate Aug<31>2005 16:59 Jul 06, 2007 Jkt 211001 PO 00000 Frm 00068 Responses per respondents 58 58 711 711 154 154 135 67 Fmt 4703 Sfmt 4703 Total responses 215 12 10 18 95 172 23 27 E:\FR\FM\09JYN1.SGM 12,470 696 7,110 12,798 14,630 26,488 3,105 1,809 09JYN1 Hours per response 0.4200 10.0000 0.4100 0.3300 0.0600 0.1100 0.2800 0.2800 Total burden hours 5,237.4000 6,960.0000 2,915.1000 4,223.3400 877.8000 2,913.6800 869.4000 506.5200 37250 Federal Register / Vol. 72, No. 130 / Monday, July 9, 2007 / Notices ESTIMATES OF ANNUALIZED HOUR BURDEN—Continued Number of respondents Form Responses per respondents Total responses Hours per response Total burden hours Heart/Lung Candidate Registration ..................................... Thoracic Registration ........................................................... Thoracic Follow-up ............................................................... Kidney Candidate Registration ............................................ Kidney Registration .............................................................. Kidney Follow-up ................................................................. Liver Candidate Registration ............................................... Liver Registration ................................................................. Liver Follow-up ..................................................................... Kidney/Pancreas Candidate Registration ............................ Kidney/Pancreas Registration .............................................. Kidney/Pancreas Follow-up ................................................. Pancreas Candidate Registration ........................................ Pancreas Registration .......................................................... Pancreas Follow-up ............................................................. Intestine Candidate Registration .......................................... Intestine Registration ........................................................... Intestine Follow-up ............................................................... Post Transplant Malignancy ................................................ 59 135 135 250 250 250 125 125 125 146 146 146 146 146 146 45 45 45 711 1 27 229 133 69 544 89 54 383 12 7 65 7 3 23 8 4 17 6 59 3,645 30,915 33,250 17,250 136,000 11,125 6,750 47,875 1,752 1,022 9,490 1,022 438 3,358 360 180 765 4,266 0.2800 0.4400 0.4130 0.2800 0.4400 0.3332 0.2800 0.4000 0.3336 0.2800 0.5300 0.5027 0.2800 0.4400 0.4133 0.2400 0.5300 0.5059 0.0800 16.5200 1,603.8000 12,767.8950 9,310.0000 7,590.0000 45,315.2000 3,115.0000 2,700.0000 15,971.1000 490.5600 541.6600 4,770.6230 286.1600 192.7200 1,387.8614 86.4000 95.4000 387.0135 341.2800 Total .............................................................................. 923 ........................ 388,628 ........................ 131,472.4329 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to: Karen Matsuoka, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503. Dated: June 28, 2007. Caroline Lewis, Associate Administrator for Management. [FR Doc. E7–13170 Filed 7–6–07; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Notice Regarding the 340B Drug Pricing Program; Children’s Hospitals Health Resources and Services Administration, HHS. ACTION: Notice. rwilkins on PROD1PC63 with NOTICES AGENCY: SUMMARY: Section 340B of the Public Health Service Act (section 340B) and section 1927(a) of the Social Security Act (section 1927(a)) implement a drug pricing program in which manufacturers who sell covered outpatient drugs to covered entities must agree to charge a price that will not exceed an amount determined under a statutory formula. Section 6004 of the Deficit Reduction Act of 2005 (Pub. L. 109–171) (section 6004) added children’s hospitals to the list of covered entities eligible to access VerDate Aug<31>2005 18:46 Jul 06, 2007 Jkt 211001 340B discounted drugs. The purpose of this notice is to inform interested parties of proposed guidelines regarding the addition of children’s hospitals that meet certain requirements, specifically: (1) The process for the addition of children’s hospitals to the 340B Program; and (2) the obligation of manufacturers to provide the statutorily mandated discount to children’s hospitals. These proposed guidelines will not take effect until final guidelines are issued. DATES: The public is invited to comment on the proposed guidelines by September 7, 2007. After consideration of the submitted comments, the Health Resources and Services Administration (HRSA) will issue the final guidelines. ADDRESSES: Address all comments to Mr. Bradford R. Lang, Public Health Analyst, Office of Pharmacy Affairs (OPA), Healthcare Systems Bureau (HSB), HRSA, 5600 Fishers Lane, Parklawn Building, Room 10C–03, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: Mr. Jimmy Mitchell, Director, OPA, HSB, HRSA, 5600 Fishers Lane, Parklawn Building, Room 10C–03, Rockville, MD 20857, or by telephone through the Pharmacy Services Support Center at 1–800–628–6297. SUPPLEMENTARY INFORMATION: (A) Background Section 602 of Public Law 102–585, the Veterans Health Care Act of 1992, enacted section 340B, Limitation on Prices of Drugs Purchased by Covered Entities and added certain PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 implementation provisions for the 340B Program to section 1927(a) of the Social Security Act. Section 340B contains the majority of the requirements for covered entities participating in the 340B Program, while the relevant provisions of section 1927(a) of the Social Security Act provide primarily for the requirement that manufacturers provide the statutorily mandated discount to covered entities. Section 340B contains a list of covered entities that are eligible to receive discounts through the 340B Program. The list includes entities such as Federally Qualified Health Centers, State-operated AIDS drug purchasing assistance programs, and certain disproportionate share hospitals. Children’s hospitals were not included as covered entities under section 340B in the Veterans Health Care Act of 1992 as enacted. Section 6004 added children’s hospitals as covered entities eligible to access 340B discounted drugs. To accomplish this, section 6004 did not amend section 340B (which contains many of the requirements for covered entities). Section 6004 amended section 1927(a) of the Social Security Act (which primarily contains requirements for manufacturers’ participation) to add children’s hospitals to the 340B Program. To be eligible for the 340B Drug Pricing Program, section 1927(a), as amended by section 6004, requires children’s hospitals to meet the requirements of clauses (i) and (iii) of section 340B(a)(4)(L) of the Public Health Service Act, which contain E:\FR\FM\09JYN1.SGM 09JYN1

Agencies

[Federal Register Volume 72, Number 130 (Monday, July 9, 2007)]
[Notices]
[Pages 37249-37250]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-13170]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

    Periodically, the Health Resources and Services Administration 
(HRSA) publishes abstracts of information collection requests under 
review by the Office of Management and Budget (OMB), in compliance with 
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request 
a copy of the clearance requests submitted to OMB for review, call the 
HRSA Reports Clearance Office on (301) 443-1129.
    The following request has been submitted to the Office of 
Management and Budget for review under the Paperwork Reduction Act of 
1995:

Proposed Project: Data System for Organ Procurement and Transplantation 
Network and Associated Forms (OMB No. 0915-0157)--Revision

    Section 372 of the Public Health Service (PHS) Act requires that 
the Secretary, by contract, provide for the establishment and operation 
of an Organ Procurement and Transplantation Network (OPTN). The OPTN, 
among other responsibilities, operates and maintains a national waiting 
list of individuals requiring organ transplants, maintains a 
computerized system for matching donor organs with transplant 
candidates on the waiting list, and operates a 24-hour system to 
facilitate matching organs with individuals included in the list.
    Data for the OPTN data system are collected from transplant 
hospitals, organ procurement organizations, and tissue-typing 
laboratories. The information is used to indicate the disease severity 
of transplant candidates, to monitor compliance of member organizations 
with OPTN rules and requirements, and to report periodically on the 
clinical and scientific status of organ donation and transplantation in 
this country. Data are used to develop transplant, donation and 
allocation policies, to determine if institutional members are 
complying with policy, to determine member specific performance, to 
ensure patient safety when no alternative sources of data exist and to 
fulfill the requirements of the OPTN Final Rule. The practical utility 
of the data collection is further enhanced by requirements that the 
OPTN data must be made available, consistent with applicable laws, for 
use by OPTN members, the Scientific Registry of Transplant Recipients, 
the Department of Health and Human Services, and others for evaluation, 
research, patient information, and other important purposes.
    Revisions in the 26 data collection forms are intended to implement 
approved reduction in data collection for candidates and recipients, to 
provide additional information specific to pediatric patients, and to 
clarify existing questions.

                                       Estimates of Annualized Hour Burden
----------------------------------------------------------------------------------------------------------------
                                     Number of     Responses per       Total         Hours per     Total burden
              Form                  respondents     respondents      responses       response          hours
----------------------------------------------------------------------------------------------------------------
Deceased Donor Registration.....              58             215          12,470          0.4200      5,237.4000
Death referral data.............              58              12             696         10.0000      6,960.0000
Living Donor Registration.......             711              10           7,110          0.4100      2,915.1000
Living Donor Follow-up..........             711              18          12,798          0.3300      4,223.3400
Donor Histocompatibility........             154              95          14,630          0.0600        877.8000
Recipient Histocompatibility....             154             172          26,488          0.1100      2,913.6800
Heart Candidate Registration....             135              23           3,105          0.2800        869.4000
Lung Candidate Registration.....              67              27           1,809          0.2800        506.5200

[[Page 37250]]

 
Heart/Lung Candidate                          59               1              59          0.2800         16.5200
 Registration...................
Thoracic Registration...........             135              27           3,645          0.4400      1,603.8000
Thoracic Follow-up..............             135             229          30,915          0.4130     12,767.8950
Kidney Candidate Registration...             250             133          33,250          0.2800      9,310.0000
Kidney Registration.............             250              69          17,250          0.4400      7,590.0000
Kidney Follow-up................             250             544         136,000          0.3332     45,315.2000
Liver Candidate Registration....             125              89          11,125          0.2800      3,115.0000
Liver Registration..............             125              54           6,750          0.4000      2,700.0000
Liver Follow-up.................             125             383          47,875          0.3336     15,971.1000
Kidney/Pancreas Candidate                    146              12           1,752          0.2800        490.5600
 Registration...................
Kidney/Pancreas Registration....             146               7           1,022          0.5300        541.6600
Kidney/Pancreas Follow-up.......             146              65           9,490          0.5027      4,770.6230
Pancreas Candidate Registration.             146               7           1,022          0.2800        286.1600
Pancreas Registration...........             146               3             438          0.4400        192.7200
Pancreas Follow-up..............             146              23           3,358          0.4133      1,387.8614
Intestine Candidate Registration              45               8             360          0.2400         86.4000
Intestine Registration..........              45               4             180          0.5300         95.4000
Intestine Follow-up.............              45              17             765          0.5059        387.0135
Post Transplant Malignancy......             711               6           4,266          0.0800        341.2800
                                 -------------------------------------------------------------------------------
    Total.......................             923  ..............         388,628  ..............    131,472.4329
----------------------------------------------------------------------------------------------------------------

    Written comments and recommendations concerning the proposed 
information collection should be sent within 30 days of this notice to: 
Karen Matsuoka, Human Resources and Housing Branch, Office of 
Management and Budget, New Executive Office Building, Room 10235, 
Washington, DC 20503.

    Dated: June 28, 2007.
Caroline Lewis,
Associate Administrator for Management.
[FR Doc. E7-13170 Filed 7-6-07; 8:45 am]
BILLING CODE 4165-15-P