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