Agency Information Collection Activities: Proposed Collection: Public Comment Request, 59788-59789 [2015-24956]
Download as PDF
<![CDATA[
59788
Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Notices
comment period related to the use of in
vitro methods as a mechanism for
assessing the in vivo product
bioequivalence (BE) of nonsystemically
absorbed drug products intended for use
in veterinary species, published in the
Federal Register of March 18, 2015 (80
FR 14146). FDA is reopening the
comment period to receive new
information.
Submit either electronic or
written comments by November 2, 2015.
ADDRESSES: You may submit comments
as follows:
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public submit the comment as a written/
paper submission and in the manner
detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
mstockstill on DSK4VPTVN1PROD with NOTICES
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2015–N–0684 for Identification of
Alternative In Vitro Bioequivalence
Pathways Which Can Reliably Ensure In
VerDate Sep<11>2014
20:43 Oct 01, 2015
Jkt 238001
Vivo Bioequivalence of Product
Performance and Quality of NonSystemically Absorbed Drug Products
for Animals; Reopening of the Comment
Period. Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION’’. The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the guidance to the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT: John
Harshman, CVM, Food and Drug
Administration, HFV–170, MPN2, 7500
Standish Place, Rockville, MD 20855,
240–402–0845.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of March 18,
2015 (80 FR 14146), FDA announced a
public meeting to discuss the use of in
vitro methods as a mechanism for
assessing the in vivo product
bioequivalence of nonsystemically
absorbed drug products intended for use
in veterinary species. In the same
notice, FDA said that it is seeking
additional public comment to the
docket. Interested persons were
originally given until May 18, 2015, to
comment on this issue. Following
publication of that notice, FDA received
a request to allow interested persons
additional time to comment. In response
to that request, FDA published a
Federal Register notice on June 10,
2015, reopening the comment period for
60 days, until August 10, 2015.
II. Request for Comments
Following publication of the June 10,
2015, notice reopening the comment
period for 60 days, FDA received a
request to allow interested persons an
additional 30 days to comment. FDA
has considered the request and is
reopening the comment period for 30
days, until November 2, 2015.
Dated: September 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–25121 Filed 10–1–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
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
SUMMARY:
E:\FR\FM\02OCN1.SGM
02OCN1
59789
Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Notices
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
Number of
responses per
respondent
Number of
respondents
Form name
Participant Information Form (PIF) ....................................
Event Record (ER) .............................................................
Total ............................................................................
90,193
18,070
108,263
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
burden per
response
(in hours)
Total
responses
1
1
........................
90,193
18,070
108,263
Total burden
hours
0.167
0.2
..........................
15,062
3,614
18,676
The estimated annual burden to
AETCs is as follows:
Number of
respondents
mstockstill on DSK4VPTVN1PROD with NOTICES
Aggregate Data Set .........................................................
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
Responses
per respondent
9
Total
responses
2
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
Hours per
response
18
20:43 Oct 01, 2015
Jkt 238001
PO 00000
Frm 00070
Fmt 4703
Sfmt 9990
32
576
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
VerDate Sep<11>2014
Total burden
hours
E:\FR\FM\02OCN1.SGM
02OCN1
]]>Agencies
[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Notices]
[Pages 59788-59789]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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
