Agency Information Collection Activities: Proposed Collection: Comment Request, 30032-30033 [2010-12964]

Download as PDF 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 http://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