Agency Information Collection Activities; Proposed Collection; Comment Request, 17217-17218 [2013-06382]

Download as PDF 17217 Federal Register / Vol. 78, No. 54 / Wednesday, March 20, 2013 / Notices K. Distribution Records Sections 212.20(c) and 212.90(a) require that written procedures regarding distribution of PET drug products be established and maintained. We estimate that it will take approximately 1 hour annually to establish and maintain records of these procedures for each PET production facility. Section 212.90(b) requires that distribution records be maintained. We estimate that it will take approximately 15 minutes to create an actual distribution record for each batch of PET drug products, with a total burden of approximately 16,157 hours for all PET producers. L. Complaints Sections 212.20(c) and 212.100 require that PET drug producers establish written procedures for dealing with complaints, as well as document how each complaint is handled. We estimate that establishing and maintaining written procedures for complaints will take approximately 1 hour annually for each PET production facility and that each facility will receive approximately one complaint a year and will spend approximately 30 minutes recording how the complaint was dealt with. TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers 21 CFR Section Number of records per recordkeeper Total annual records 212.20(c) and (e); 212.50(a) and (b) ..................................... 212.20(d) and (e); 212.50(c); 212.80(c) ................................. 129 129 1.71 501 221 64,629 212.20(c); 212.30(b); 212.50(d), 212.60(f) ............................. 212.30(b); 212.50(d); 212.60(f) .............................................. 129 129 15 3,758 1,935 484,782 212.20(c); 212.40(a) and (b) .................................................. 212.40(e) ................................................................................ 129 129 2 36 258 4,644 212.20(c); 212.60(a) and (b); 212.61(a); 212.70(a), (b), and (d). 212.60(g); 212.61(b); 212.70(d)(2) and (d)(3) ....................... 129 25 3,225 129 501 64,629 212.70(f) ................................................................................. 212.20(c); 212.71(a) ............................................................... 212.71(b) ................................................................................ 212.20(c); 212.71(d) ............................................................... 212.20(c); 212.90(a) ............................................................... 212.90(b) ................................................................................ 129 129 129 129 129 129 1 36 1 1 1 501 129 4,644 129 129 129 64,629 212.20(c); 212.100(a) ............................................................. 212.100(b) and (c) .................................................................. 129 129 1 1 129 129 Total ................................................................................ ........................ ........................ ........................ 1 There Average burden per recordkeeper 20 ................ .5 ................. (30 min.) 1 .................. .08 ............... (5 min.) 1 .................. .166 ............. (10 min.) 1 .................. Total hours 4,420 32,315 1,935 40,237 258 771 3,225 .16 ............... (10 min.) 1 .................. 1 .................. 1 .................. 1 .................. 1 .................. .25 ............... (15 min.) 1 .................. .5 ................. (30 min.) 10,728 ..................... 115,400 129 4,644 129 129 129 16,157 129 65 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 21 CFR Section Number of respondents Annual frequency of disclosure Total annual disclosures Hours per disclosure Total hours 212.70(e) .............................................................................. 129 .25 32 1 32 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: March 14, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–06351 Filed 3–19–13; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration srobinson on DSK4SPTVN1PROD with NOTICES BILLING CODE 4160–01–P Agency Information Collection Activities; Proposed Collection; Comment Request ACTION: Notice. SUMMARY: 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 VerDate Mar<14>2013 18:04 Mar 19, 2013 Jkt 229001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 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, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443– 1984. HRSA especially requests comments on: (1) The necessity and utility of the E:\FR\FM\20MRN1.SGM 20MRN1 17218 Federal Register / Vol. 78, No. 54 / Wednesday, March 20, 2013 / Notices proposed information collection for the proper performance of the agency’s functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Information Collection Request Title: HRSA AIDS Education and Training Centers Evaluation Activities: (OMB No. 0915–0281)—Revision Abstract: The AIDS Education and Training Centers (AETC) Program, under the Ryan White HIV/AIDS Program established by Title XXVI of the Public Health Service (PHS) Act, as amended, supports a network of regional and national centers that conduct targeted, multi-disciplinary education and training programs for health care providers treating persons with HIV/AIDS. The AETCs’ purpose is to increase the number of health care providers who are effectively educated and motivated to counsel, diagnose, treat, and medically manage individuals with HIV infection, and to help prevent high risk behaviors that lead to HIV transmission. As part of an ongoing effort to evaluate AETC activities, information is needed on AETC training sessions, consultations, and technical assistance activities. Each regional center collects information on AETC training events, and is required to report aggregate data on their activities to HRSA’s HIV/AIDS Bureau (HAB). The data provides information on the number of training events, including clinical trainings and consultations, as well as technical assistance activities conducted by each regional center, the number of health care providers receiving professional training or consultation, and the time and effort expended on different levels of training and consultation activities. In addition, information is obtained on the populations served by AETC trainees, and the increase in capacity achieved through training events. Collection of this information allows HRSA’s HAB to provide information on training activities and types of education and training provided to Ryan White HIV/AIDS Program Grantees, Number of respondents Form Responses per respondent resource allocation, and capacity expansion. Trainees are asked to complete the Participant Information Form (PIF) for each activity they complete, and trainers are asked to complete the Event Record (ER). 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 Information Collection Request are summarized in the table below. The annual estimate of burden is as follows: Total responses Average burden per response (in hours) Total burden hours PIF .................................................................. ER .................................................................. 116,624 18,070 1 1 116,624 18,070 0.167 0.2 19,476.2 3,614.0 Total ........................................................ 134,694 ............................ 134,694 .............................. 23,090.2 Number of respondents Responses per respondent Total responses Hours per response Total burden hours 16 2 32 32 1024.0 The estimated annual burden to AETCs is as follows: Aggregate Data Set ......................................... The total burden hours are 24,114.2. Submit your comments to paperwork@hrsa.gov or mail to the HRSA Reports Clearance Officer, Room 10–29, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Deadline: Comments on this Information Collection Request must be received within 60 days of this notice. srobinson on DSK4SPTVN1PROD with NOTICES ADDRESSES: Dated: March 12, 2013. Bahar Niakan, Director, Division of Policy and Information Coordination. [FR Doc. 2013–06382 Filed 3–19–13; 8:45 am] BILLING CODE 4165–15–P VerDate Mar<14>2013 18:04 Mar 19, 2013 Jkt 229001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel, ‘‘Limited Competition: Collaborative Partnership to Advance Global Biomedical Research Programs (U01).’’ Date: April 12, 2013. Time: 1:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6700B Rockledge Drive, Bethesda, MD 20817, (Telephone Conference Call). Contact Person: Andrea L Wurster, Ph.D., Scientific Review Officer, Scientific Review Program, DEA/NIAID/NIH/DHHS, Room E:\FR\FM\20MRN1.SGM 20MRN1

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[Federal Register Volume 78, Number 54 (Wednesday, March 20, 2013)]
[Notices]
[Pages 17217-17218]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06382]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities; Proposed Collection; 
Comment Request

ACTION: Notice.

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

SUMMARY: 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, email paperwork@hrsa.gov or 
call the HRSA Reports Clearance Officer at (301) 443-1984.
    HRSA especially requests comments on: (1) The necessity and utility 
of the

[[Page 17218]]

proposed information collection for the proper performance of the 
agency's functions, (2) the accuracy of the estimated burden, (3) ways 
to enhance the quality, utility, and clarity of the information to be 
collected, and (4) the use of automated collection techniques or other 
forms of information technology to minimize the information collection 
burden.

Information Collection Request Title: HRSA AIDS Education and Training 
Centers Evaluation Activities: (OMB No. 0915-0281)--Revision

    Abstract: The AIDS Education and Training Centers (AETC) Program, 
under the Ryan White HIV/AIDS Program established by Title XXVI of the 
Public Health Service (PHS) Act, as amended, supports a network of 
regional and national centers that conduct targeted, multi-disciplinary 
education and training programs for health care providers treating 
persons with HIV/AIDS. The AETCs' purpose is to increase the number of 
health care providers who are effectively educated and motivated to 
counsel, diagnose, treat, and medically manage individuals with HIV 
infection, and to help prevent high risk behaviors that lead to HIV 
transmission.
    As part of an ongoing effort to evaluate AETC activities, 
information is needed on AETC training sessions, consultations, and 
technical assistance activities. Each regional center collects 
information on AETC training events, and is required to report 
aggregate data on their activities to HRSA's HIV/AIDS Bureau (HAB). The 
data provides information on the number of training events, including 
clinical trainings and consultations, as well as technical assistance 
activities conducted by each regional center, the number of health care 
providers receiving professional training or consultation, and the time 
and effort expended on different levels of training and consultation 
activities. In addition, information is obtained on the populations 
served by AETC trainees, and the increase in capacity achieved through 
training events. Collection of this information allows HRSA's HAB to 
provide information on training activities and types of education and 
training provided to Ryan White HIV/AIDS Program Grantees, resource 
allocation, and capacity expansion. Trainees are asked to complete the 
Participant Information Form (PIF) for each activity they complete, and 
trainers are asked to complete the Event Record (ER).
    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 Information Collection Request are summarized in the table below.
    The annual estimate of burden is as follows:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                       Average burden
                             Form                                  Number of       Responses per    Total responses  per response  (in    Total burden
                                                                  respondents       respondent                             hours)             hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
PIF..........................................................           116,624                 1           116,624              0.167          19,476.2
ER...........................................................            18,070                 1            18,070              0.2             3,614.0
                                                              ------------------------------------------------------------------------------------------
    Total....................................................           134,694  ................           134,694  .................          23,090.2
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The estimated annual burden to AETCs is as follows:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Number of        Responses per                           Hours per         Total burden
                                                              respondents         respondent      Total responses        response            hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aggregate Data Set.......................................                16                  2                 32                 32             1024.0
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The total burden hours are 24,114.2.

ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail to the 
HRSA Reports Clearance Officer, Room 10-29, Parklawn Building, 5600 
Fishers Lane, Rockville, MD 20857.
    Deadline: Comments on this Information Collection Request must be 
received within 60 days of this notice.

    Dated: March 12, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-06382 Filed 3-19-13; 8:45 am]
BILLING CODE 4165-15-P