80 FR 59788 - Agency Information Collection Activities: Proposed Collection: Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 80, Issue 191 (October 2, 2015)
Health Resources and Services Administration
Federal Register Volume 80, Issue 191 (October 2, 2015)
| Page Range | 59788-59789 | |
| FR Document | 2015-24956 |
[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)] [Notices] [Pages 59788-59789] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-24956] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information [[Page 59789]] Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this Information Collection Request must be received no later than December 1, 2015. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 10-29, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: 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 Information Collection Clearance Officer at (301) 443-1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. 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 title XXVI of the Public Health Service Act, as amended, Ryan White HIV/AIDS Program legislation 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 AETC Program's 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. Need and Proposed Use of the Information: 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 and the HIV/AIDS Bureau (HAB). These data provide 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 and 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. Likely Respondents: Trainees are asked to complete the Participant Information Form (PIF) once a year, and trainers are asked to complete an Event Record (ER) for each training event they conduct during the year. In addition to each regional AETC (8 total), the AETC National Coordinating Resource Center will compile these data into a data set and submit to HAB once a year. 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 estimated annual response burden to trainers, as well as attendees of training programs as follows: ---------------------------------------------------------------------------------------------------------------- Average Number of Number of Total burden per Total burden Form name respondents responses per responses response (in hours respondent hours) ---------------------------------------------------------------------------------------------------------------- Participant Information Form 90,193 1 90,193 0.167 15,062 (PIF).......................... Event Record (ER)............... 18,070 1 18,070 0.2 3,614 Total....................... 108,263 .............. 108,263 .............. 18,676 ---------------------------------------------------------------------------------------------------------------- The estimated annual burden to AETCs is as follows: ---------------------------------------------------------------------------------------------------------------- Number of Responses per Total Hours per Total burden respondents respondent responses response hours ---------------------------------------------------------------------------------------------------------------- Aggregate Data Set............ 9 2 18 32 576 ---------------------------------------------------------------------------------------------------------------- The total burden hours are 19,252. HRSA specifically requests comments on (1) the necessity and utility of the 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. Jackie Painter, Director, Division of the Executive Secretariat. [FR Doc. 2015-24956 Filed 10-1-15; 8:45 am] BILLING CODE 4165-15-P
![59788 Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Notices
comment period related to the use of in Vivo Bioequivalence of Product for electronic access to the guidance
vitro methods as a mechanism for Performance and Quality of Non- document.
assessing the in vivo product Systemically Absorbed Drug Products FOR FURTHER INFORMATION CONTACT: John
bioequivalence (BE) of nonsystemically for Animals; Reopening of the Comment Harshman, CVM, Food and Drug
absorbed drug products intended for use Period. Received comments will be Administration, HFV–170, MPN2, 7500
in veterinary species, published in the placed in the docket and, except for Standish Place, Rockville, MD 20855,
Federal Register of March 18, 2015 (80 those submitted as ‘‘Confidential 240–402–0845.
FR 14146). FDA is reopening the Submissions,’’ publicly viewable at
SUPPLEMENTARY INFORMATION:
comment period to receive new http://www.regulations.gov or at the
information. Division of Dockets Management I. Background
between 9 a.m. and 4 p.m., Monday In the Federal Register of March 18,
DATES: Submit either electronic or
through Friday. 2015 (80 FR 14146), FDA announced a
written comments by November 2, 2015. • Confidential Submissions—To
ADDRESSES: You may submit comments public meeting to discuss the use of in
submit a comment with confidential vitro methods as a mechanism for
as follows: information that you do not wish to be assessing the in vivo product
Electronic Submissions made publicly available submit your bioequivalence of nonsystemically
comments only as a written/paper absorbed drug products intended for use
Submit electronic comments in the submission. You should submit two
following way: in veterinary species. In the same
copies total. One copy will include the notice, FDA said that it is seeking
• Federal eRulemaking Portal: http:// information you claim to be confidential
www.regulations.gov. Follow the additional public comment to the
with a heading or cover note that states docket. Interested persons were
instructions for submitting comments. ‘‘THIS DOCUMENT CONTAINS
Comments submitted electronically, originally given until May 18, 2015, to
CONFIDENTIAL INFORMATION’’. The comment on this issue. Following
including attachments, to http:// Agency will review this copy, including
www.regulations.gov will be posted to publication of that notice, FDA received
the claimed confidential information, in
the docket unchanged. Because your a request to allow interested persons
its consideration of comments. The
comment will be made public, you are additional time to comment. In response
second copy, which will have the
solely responsible for ensuring that your to that request, FDA published a
claimed confidential information
comment does not include any Federal Register notice on June 10,
redacted/blacked out, will be available
confidential information that you or a 2015, reopening the comment period for
for public viewing and posted on http://
third party may not wish to be posted, 60 days, until August 10, 2015.
www.regulations.gov. Submit both
such as medical information, your or copies to the Division of Dockets II. Request for Comments
anyone else’s Social Security number, or Management. If you do not wish your Following publication of the June 10,
confidential business information, such name and contact information to be 2015, notice reopening the comment
as a manufacturing process. Please note made publicly available, you can period for 60 days, FDA received a
that if you include your name, contact provide this information on the cover request to allow interested persons an
information, or other information that sheet and not in the body of your additional 30 days to comment. FDA
identifies you in the body of your comments and you must identify this has considered the request and is
comments, that information will be information as ‘‘confidential.’’ Any reopening the comment period for 30
posted on http://www.regulations.gov. information marked as ‘‘confidential’’
• If you want to submit a comment days, until November 2, 2015.
will not be disclosed except in
with confidential information that you accordance with 21 CFR 10.20 and other Dated: September 28, 2015.
do not wish to be made available to the applicable disclosure law. For more Leslie Kux,
public submit the comment as a written/ information about FDA’s posting of Associate Commissioner for Policy.
paper submission and in the manner comments to public dockets, see 80 FR [FR Doc. 2015–25121 Filed 10–1–15; 8:45 am]
detailed (see ‘‘Written/Paper 56469, September 18, 2015, or access BILLING CODE 4164–01–P
Submissions’’ and ‘‘Instructions’’). the information at: http://www.fda.gov/
Written/Paper Submissions regulatoryinformation/dockets/
default.htm. DEPARTMENT OF HEALTH AND
Submit written/paper submissions as Docket: For access to the docket to HUMAN SERVICES
follows: read background documents or the
• Mail/Hand delivery/Courier (for electronic and written/paper comments Health Resources and Services
written/paper submissions): Division of received, go to http:// Administration
Dockets Management (HFA–305), Food www.regulations.gov and insert the
and Drug Administration, 5630 Fishers docket number, found in brackets in the Agency Information Collection
Lane, Rm. 1061, Rockville, MD 20852. heading of this document, into the Activities: Proposed Collection: Public
• For written/paper comments ‘‘Search’’ box and follow the prompts Comment Request
submitted to the Division of Dockets and/or go to the Division of Dockets AGENCY: Health Resources and Services
Management, FDA will post your Management, 5630 Fishers Lane, Rm. Administration, HHS.
comment, as well as any attachments, 1061, Rockville, MD 20852. ACTION: Notice.
except for information submitted, Submit written requests for single
mstockstill on DSK4VPTVN1PROD with NOTICES
marked and identified, as confidential, copies of the guidance to the Policy and SUMMARY: In compliance with the
if submitted as detailed in Regulations Staff (HFV–6), Center for requirement for opportunity for public
‘‘Instructions.’’ Veterinary Medicine, Food and Drug comment on proposed data collection
Instructions: All submissions received Administration, 7519 Standish Pl., projects (section 3506(c)(2)(A) of the
must include the Docket No. FDA– Rockville, MD 20855. Send one self- Paperwork Reduction Act of 1995), the
2015–N–0684 for Identification of addressed adhesive label to assist that Health Resources and Services
Alternative In Vitro Bioequivalence office in processing your requests. See Administration (HRSA) announces
Pathways Which Can Reliably Ensure In the SUPPLEMENTARY INFORMATION section plans to submit an Information
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![Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Notices 59789
Collection Request (ICR), described national centers that conduct targeted, education and training provided to Ryan
below, to the Office of Management and multi-disciplinary education and White HIV/AIDS Program Grantees;
Budget (OMB). Prior to submitting the training programs for health care resource allocation; and capacity
ICR to OMB, HRSA seeks comments providers treating persons with HIV/ expansion.
from the public regarding the burden AIDS. The AETC Program’s purpose is Likely Respondents: Trainees are
estimate, below, or any other aspect of to increase the number of health care asked to complete the Participant
the ICR. providers who are effectively educated Information Form (PIF) once a year, and
DATES: Comments on this Information and motivated to counsel, diagnose, trainers are asked to complete an Event
Collection Request must be received no treat, and medically manage individuals Record (ER) for each training event they
later than December 1, 2015. with HIV infection, and to help prevent conduct during the year. In addition to
ADDRESSES: Submit your comments to high risk behaviors that lead to HIV each regional AETC (8 total), the AETC
paperwork@hrsa.gov or mail the HRSA transmission. National Coordinating Resource Center
Information Collection Clearance Need and Proposed Use of the will compile these data into a data set
Officer, Room 10–29, Parklawn Information: As part of an ongoing effort and submit to HAB once a year.
Building, 5600 Fishers Lane, Rockville, to evaluate AETC activities, information Burden Statement: Burden in this
MD 20857. is needed on AETC training sessions, context means the time expended by
FOR FURTHER INFORMATION CONTACT: To consultations, and technical assistance persons to generate, maintain, retain,
request more information on the activities. Each regional center collects disclose or provide the information
proposed project or to obtain a copy of information on AETC training events, requested. This includes the time
the data collection plans and draft and is required to report aggregate data needed to review instructions; to
instruments, email paperwork@hrsa.gov on their activities to HRSA and the HIV/ develop, acquire, install and utilize
or call the HRSA Information Collection AIDS Bureau (HAB). These data provide technology and systems for the purpose
Clearance Officer at (301) 443–1984. information on the number of training of collecting, validating and verifying
SUPPLEMENTARY INFORMATION: When events, including clinical trainings and information, processing and
submitting comments or requesting consultations, as well as technical maintaining information, and disclosing
information, please include the assistance activities conducted by each and providing information; to train
information request collection title for regional center, the number of health personnel and to be able to respond to
reference. care providers receiving professional a collection of information; to search
Information Collection Request Title: training or consultation, and the time data sources; to complete and review
HRSA AIDS Education and Training and effort expended on different levels the collection of information; and to
Centers Evaluation Activities (OMB No. of training and consultation activities. transmit or otherwise disclose the
0915–0281)—Revision. In addition, information is obtained on information. The total annual burden
Abstract: The AIDS Education and the populations served by AETC hours estimated for this Information
Training Centers (AETC) Program, trainees and the increase in capacity Collection Request are summarized in
under the title XXVI of the Public achieved through training events. the table below.
Health Service Act, as amended, Ryan Collection of this information allows The estimated annual response
White HIV/AIDS Program legislation HRSA and HAB to provide information burden to trainers, as well as attendees
supports a network of regional and on training activities and types of of training programs as follows:
Average
Number of
Number of Total burden per Total burden
Form name responses per
respondents responses response hours
respondent (in hours)
Participant Information Form (PIF) .................................... 90,193 1 90,193 0.167 15,062
Event Record (ER) ............................................................. 18,070 1 18,070 0.2 3,614
Total ............................................................................ 108,263 ........................ 108,263 .......................... 18,676
The estimated annual burden to
AETCs is as follows:
Number of Responses Total Hours per Total burden
respondents per respondent responses response hours
Aggregate Data Set ......................................................... 9 2 18 32 576
The total burden hours are 19,252. estimated burden, (3) ways to enhance technology to minimize the information
HRSA specifically requests comments the quality, utility, and clarity of the collection burden.
on (1) the necessity and utility of the information to be collected, and (4) the
Jackie Painter,
proposed information collection for the use of automated collection techniques
mstockstill on DSK4VPTVN1PROD with NOTICES
proper performance of the agency’s Director, Division of the Executive Secretariat.
or other forms of information
functions, (2) the accuracy of the [FR Doc. 2015–24956 Filed 10–1–15; 8:45 am]
BILLING CODE 4165–15–P
VerDate Sep<11>2014 20:43 Oct 01, 2015 Jkt 238001 PO 00000 Frm 00070 Fmt 4703 Sfmt 9990 E:\FR\FM\02OCN1.SGM 02OCN1](https://thefederalregister.org/doc/80_FR_59979/page/2.svg)
Document Created: 2015-12-15 08:44:50
Document Modified: 2015-12-15 08:44:50
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this Information Collection Request must be received no later than December 1, 2015. | |
| Contact | To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email [email protected] or call the HRSA Information Collection Clearance Officer at (301) 443-1984. | |
| FR Citation | 80 FR 59788 |
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