Agency Information Collection Activities: Proposed Collection: Comment Request, 30032-30033 [2010-12964]
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30032
Federal Register / Vol. 75, No. 103 / Friday, May 28, 2010 / Notices
Reports Clearance Officer at (301) 443–
1129.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the agency; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
comments and suggestions submitted
within 60 days of this publication.
Dated: May 25, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010–12877 Filed 5–27–10; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, e-mail
paperwork@hrsa.gov or call the HRSA
Proposed Project: Organ Procurement
and Transplantation Network and
Scientific Registry of Transplant
Recipients Data System (OMB No.
0915–0157)—Extension
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.
Number of
respondents
jlentini on DSKJ8SOYB1PROD with NOTICES
Form
Deceased Donor Registration ..............................................
Death referral data ...............................................................
Death Notification Referral—Eligible ...................................
Death Notification Referral—Imminent ................................
Living Donor Registration ....................................................
Living Donor Follow-up ........................................................
Donor Histocompatibility ......................................................
Recipient Histocompatibility .................................................
Heart Candidate Registration ..............................................
Lung Candidate Registration ...............................................
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 ................................................
VerDate Mar<15>2010
17:43 May 27, 2010
Jkt 220001
PO 00000
Frm 00066
Responses
per
respondents
58
58
58
58
308
308
156
156
127
68
51
127
127
241
241
241
129
129
129
143
143
143
143
143
143
44
44
44
684
Fmt 4703
Sfmt 4703
216
12
161
168
39
50
131
196
35
42
2
36
320
183
83
742
109
58
519
14
7
85
7
3
20
7
5
28
10
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 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.
No revisions of the 26 data collection
forms are proposed at this time;
however, the OPTN is currently
undergoing a review of the forms and
expects to submit proposed revisions
within the next year.
The annual estimate of burden is as
follows:
Total
responses
12,528
696
9338
9744
12,012
15,400
20,436
30,576
4,445
2,856
102
4,572
40,640
44,103
20,003
178,822
14,061
7,482
66,951
2,002
1,001
12,155
1,001
429
2,860
308
220
1,232
6,840
E:\FR\FM\28MYN1.SGM
28MYN1
Hours per
response
0.7500
10.0000
0.2000
0.5000
0.6500
0.5000
0.1000
0.2000
0.5000
0.5000
0.5000
0.7500
0.6500
0.5000
0.7500
0.5500
0.5000
0.6500
0.5000
0.5000
0.9000
0.8500
0.5000
0.7500
0.6500
0.5000
0.9000
0.8500
0.2000
Total burden
hours
9,396.00
6,960.00
1,867.60
4,872.00
7,807.80
7,700.00
2,043.60
6,115.20
2,222.50
1,428.00
51.00
3,429.00
26,416.00
22,051.50
15,002.25
98,352.10
7,030.50
4,863.30
33,475.50
1,001.00
900.90
10,331.75
500.50
321.75
1,859.00
154.00
198.00
1,047.20
1,368.00
Federal Register / Vol. 75, No. 103 / Friday, May 28, 2010 / Notices
Number of
respondents
Form
Total ..............................................................................
463
Responses
per
respondents
........................
Total
responses
522,815
Hours per
response
........................
30033
Total burden
hours
278,765.95
* Includes an estimated 2,500 kidney transplant patients transplanted prior to the initiation of the data system.
E-mail comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–33,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments
should be received within 60 days of
this notice.
Dated: May 25, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2010–12964 Filed 5–27–10; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0119]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Registration of
Food Facilities Under the Public Health
Security and Bioterrorism
Preparedness and Response Act of
2002
AGENCY:
Food and Drug Administration,
HHS.
jlentini on DSKJ8SOYB1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by June 28,
2010.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0502. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management, Food and Drug
VerDate Mar<15>2010
17:43 May 27, 2010
Jkt 220001
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Registration of Food Facilities Under
the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002— (OMB Control
Number 0910–0502)—Extension
The Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism
Act) added section 415 of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 350d), which requires
domestic and foreign facilities that
manufacture, process, pack, or hold
food for human or animal consumption
in the United States to register with
FDA. Sections 1.230 through 1.235 of
FDA’s regulations (21 CFR 1.230
through 1.235) set forth the procedures
for registration of food facilities.
Information provided to FDA under
these regulations will help the agency to
notify quickly the facilities that might
be affected by a deliberate or accidental
contamination of the food supply.
Description of Respondents: The
respondents to this information
collection include owners, operators, or
agents in charge of domestic or foreign
facilities that manufacture/process,
pack, or hold food for human or animal
consumption in the United States.
Domestic facilities are required to
register whether or not food from the
facility enters interstate commerce.
Foreign facilities that manufacture/
process, pack, or hold food also are
required to register unless food from
that facility undergoes further
processing (including packaging) by
another foreign facility before the food
is exported to the United States.
However, if the subsequent foreign
facility performs only a minimal
activity, such as putting on a label, both
facilities are required to register.
FDA’s regulations require that each
facility that manufactures, processes,
packs, or holds food for human or
animal consumption in the United
States register with FDA using Form
FDA 3537 (§ 1.231). The term ‘‘Form
FDA 3537’’ refers to both the paper
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
version of the form and the electronic
system known as the Food Facility
Registration Module, which is available
at https://www.access.fda.gov. The
agency strongly encourages electronic
registration because it is faster and more
convenient. The system the agency has
developed can accept electronic
registrations from anywhere in the
world 24 hours a day, 7 days a week. A
registering facility will receive
confirmation of electronic registration
and its registration number
instantaneously once all the required
fields on the registration screen are
filled in. However, paper registrations
will be accepted. Form FDA 3537 is
available for download for registration
by mail, fax, or CD–ROM. Registration
by mail may take several weeks to
several months, depending on the speed
of the mail system and the number of
paper registrations that FDA will have
to enter manually.
Information FDA requires on the
registration form includes the name and
full address of the facility; emergency
contact information; all trade names the
facility uses; applicable food product
categories identified in § 170.3 (21 CFR
170.3), unless ‘‘most/all’’ human food
categories ‘‘or none of the above
mandatory categories’’ is selected as a
response; and a certification statement
that includes the name of the individual
authorized to submit the registration
form. Additionally, facilities are
encouraged to submit their preferred
mailing address; type of activity
conducted at the facility; food categories
not included under § 170.3, but which
are helpful to FDA for responding to an
incident; type of storage, if the facility
is primarily a holding facility; and
approximate dates of operation if the
facility’s business is seasonal.
In addition to registering, a facility is
required to submit timely updates
within 60 days of a change to any
required information on its registration
form, using Form FDA 3537 (§ 1.234),
and to cancel its registration when the
facility ceases to operate or is sold to
new owners or ceases to manufacture/
process, pack, or hold food for
consumption in the United States, using
Form FDA 3537a (§ 1.235).
In the Federal Register of March 16,
2010 (75 FR 12547), FDA published a
60-day notice requesting public
comment on the proposed collection of
E:\FR\FM\28MYN1.SGM
28MYN1
Agencies
[Federal Register Volume 75, Number 103 (Friday, May 28, 2010)]
[Notices]
[Pages 30032-30033]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-12964]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Comment Request
In compliance with the requirement for opportunity for public
comment on proposed data collection projects (section 3506(c)(2)(A) of
Title 44, United States Code, as amended by the Paperwork Reduction Act
of 1995, Pub. L. 104-13), the Health Resources and Services
Administration (HRSA) publishes periodic summaries of proposed projects
being developed for submission to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995. To request more
information on the proposed project or to obtain a copy of the data
collection plans and draft instruments, e-mail paperwork@hrsa.gov or
call the HRSA Reports Clearance Officer at (301) 443-1129.
Comments are invited on: (a) The proposed collection of information
for the proper performance of the functions of the agency; (b) the
accuracy of the agency's estimate of the burden of the proposed
collection of information; (c) ways to enhance the quality, utility,
and clarity of the information to be collected; and (d) ways to
minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology.
Proposed Project: Organ Procurement and Transplantation Network and
Scientific Registry of Transplant Recipients Data System (OMB No. 0915-
0157)--Extension
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 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.
No revisions of the 26 data collection forms are proposed at this
time; however, the OPTN is currently undergoing a review of the forms
and expects to submit proposed revisions within the next year.
The annual estimate of burden is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Form respondents respondents responses response hours
----------------------------------------------------------------------------------------------------------------
Deceased Donor Registration..... 58 216 12,528 0.7500 9,396.00
Death referral data............. 58 12 696 10.0000 6,960.00
Death Notification Referral-- 58 161 9338 0.2000 1,867.60
Eligible.......................
Death Notification Referral-- 58 168 9744 0.5000 4,872.00
Imminent.......................
Living Donor Registration....... 308 39 12,012 0.6500 7,807.80
Living Donor Follow-up.......... 308 50 15,400 0.5000 7,700.00
Donor Histocompatibility........ 156 131 20,436 0.1000 2,043.60
Recipient Histocompatibility.... 156 196 30,576 0.2000 6,115.20
Heart Candidate Registration.... 127 35 4,445 0.5000 2,222.50
Lung Candidate Registration..... 68 42 2,856 0.5000 1,428.00
Heart/Lung Candidate 51 2 102 0.5000 51.00
Registration...................
Thoracic Registration........... 127 36 4,572 0.7500 3,429.00
Thoracic Follow-up.............. 127 320 40,640 0.6500 26,416.00
Kidney Candidate Registration... 241 183 44,103 0.5000 22,051.50
Kidney Registration............. 241 83 20,003 0.7500 15,002.25
Kidney Follow-up *.............. 241 742 178,822 0.5500 98,352.10
Liver Candidate Registration.... 129 109 14,061 0.5000 7,030.50
Liver Registration.............. 129 58 7,482 0.6500 4,863.30
Liver Follow-up................. 129 519 66,951 0.5000 33,475.50
Kidney/Pancreas Candidate 143 14 2,002 0.5000 1,001.00
Registration...................
Kidney/Pancreas Registration.... 143 7 1,001 0.9000 900.90
Kidney/Pancreas Follow-up....... 143 85 12,155 0.8500 10,331.75
Pancreas Candidate Registration. 143 7 1,001 0.5000 500.50
Pancreas Registration........... 143 3 429 0.7500 321.75
Pancreas Follow-up.............. 143 20 2,860 0.6500 1,859.00
Intestine Candidate Registration 44 7 308 0.5000 154.00
Intestine Registration.......... 44 5 220 0.9000 198.00
Intestine Follow-up............. 44 28 1,232 0.8500 1,047.20
Post Transplant Malignancy...... 684 10 6,840 0.2000 1,368.00
-------------------------------------------------------------------------------
[[Page 30033]]
Total....................... 463 .............. 522,815 .............. 278,765.95
----------------------------------------------------------------------------------------------------------------
* Includes an estimated 2,500 kidney transplant patients transplanted prior to the initiation of the data
system.
E-mail comments to paperwork@hrsa.gov or mail the HRSA Reports
Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments should be received within 60 days
of this notice.
Dated: May 25, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information Coordination.
[FR Doc. 2010-12964 Filed 5-27-10; 8:45 am]
BILLING CODE 4165-15-P