60-day FRN

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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: http://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to http://
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 http://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’’).

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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

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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
http://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 http://
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: http://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 http://
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

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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]
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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:

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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
[email protected] 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 [email protected]
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

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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

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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]
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Total burden
hours

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