Roadmap for Engaging With the Food and Drug Administration's Center for Drug Evaluation and Research; Public Workshop, 16044-16045 [2017-06370]
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16044
Federal Register / Vol. 82, No. 61 / Friday, March 31, 2017 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
21 CFR section
1271.265(e)
1271.270(a)
1271.270(e)
1271.290(d)
1271.320(b)
Number of
records per
recordkeeper
Total annual
records
Average burden per
recordkeeping
Total hours 3
..............................................................
..............................................................
..............................................................
and (e) .................................................
..............................................................
1,561
1,561
1,774
1,561
1,249
1,324.08
1,324.08
2
66.25
5
2,066,890
2,066,890
3,548
103,419
6,245
.083 (5 minutes) ........
.25 (15 minutes) ........
.5 (30 minutes) ..........
.25 (15 minutes) ........
1 ................................
171,552
516,723
1,774
25,855
6,245
Total ..................................................................
........................
........................
........................
....................................
2,066,060
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
1271.47(a), 1271.85(b)(2), 1271.160(b)(2) and (d)(1), 1271.180(a), 1271.190(d)(1), 1271.200(b), 1271.200(c), 1271.230(a),
1271.250(a), 1271.265(e), 1271.265(f), 1271.270(b) and (d), 1271.290(b)(1), and 1271.320(a).
3 Rounded to the nearest whole number.
2 Sections
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR section
Number of
disclosures
per respondent
Total annual
disclosures
Average burden per
disclosure
Total hours
1271.55(a) ................................................................
1271.60(c) and (d)(2) ...............................................
1271.290(c) ..............................................................
1271.290(f) ...............................................................
1271.370(b) and (c) .................................................
1,551
1,375
1,561
1,561
1,561
1,422.88
416
1,324.08
1
1,324.08
2,206,890
572,000
2,066,890
1,561
2,066,890
.5 (30 minutes) ..........
.5 (30 minutes) ..........
.083 (5 minutes) ........
1 ................................
.25 (15 minutes) ........
1,103,445
286,000
171,552
1,561
516,723
Total ..................................................................
........................
........................
........................
....................................
2,079,281
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–06398 Filed 3–30–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0001]
Roadmap for Engaging With the Food
and Drug Administration’s Center for
Drug Evaluation and Research; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration’s (FDA’s) Center for
Drug Evaluation and Research (CDER),
is announcing the following public
workshop entitled ‘‘Roadmap for
Engaging with FDA’s Center for Drug
Evaluation and Research (CDER).’’ The
purpose of this workshop is to help the
public learn how to successfully engage
with CDER.
DATES: The public workshop will be
held on May 12, 2017, from 9 a.m. to 3
p.m.
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SUMMARY:
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The public workshop will
be held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20903–0002.
Entrance for the public workshop
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Chris Melton, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–7381, NAVCDER@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing a public
workshop entitled ‘‘Roadmap for
Engaging with FDA’s Center for Drug
Evaluation and Research (CDER).’’ This
workshop is intended to help the public
learn the most effective ways to
successfully engage with CDER. There
will be presentations on learning about
the drug approval process, as well as the
PO 00000
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opportunity for questions and answers
following each presentation.
II. Participating in the Public Workshop
Registration: Persons interested in
attending this workshop must register
online at https://www.eventbrite.com/e/
fda-public-workshop-roadmap-forengaging-with-fdas-center-for-drugevaluation-and-research-cder-tickets28608664285?utm_source=eb_
email&utm_medium=email&utm_
campaign=new_event_email&utm_
term=viewmyevent_button. Please
provide complete contact information
for each attendee, including name, title,
affiliation, address, email and
telephone.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public workshop must
register by May 5, 2016, 6 p.m. EST.
Early registration is recommended
because seating is limited; therefore,
FDA may limit the number of
participants from each organization. If
time and space permit, onsite
registration on the day of the public
workshop will be provided beginning at
8 a.m. We will let registrants know if
registration closes before the day of the
public workshop.
If you need special accommodations
due to a disability, please contact Chris
Melton no later than May 1, 2017.
E:\FR\FM\31MRN1.SGM
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Federal Register / Vol. 82, No. 61 / Friday, March 31, 2017 / Notices
Transcripts: Please be advised that as
soon as a transcript of the public
workshop is available, it will be
assessable at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. A transcript
will also be available in either hardcopy
or on CD–ROM, after submission of a
Freedom of Information request. The
Freedom of Information office address is
available on the Agency’s Web site at
https://www.fda.gov.
Dated: March 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–06370 Filed 3–30–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Notice To Propose the Re-Designation
of the Service Delivery Area for the
Tolowa Dee-ni’ Nation (Smith River
Rancheria)
Indian Health Service,
Department of Health and Human
Services.
AGENCY:
ACTION:
Notice.
This notice advises the public
that the Indian Health Service (IHS)
proposes to expand the geographic
boundaries of the Service Delivery Area
for the Tolowa Dee-ni’ Nation (Tribe)
previously known as the Smith River
Rancheria of Smith River, California.
The Tolowa Dee-ni’s Tribal
Headquarters is located three miles
south of the California-Oregon border in
Northern California.
The entire State of California,
excluding the counties of Alameda,
Contra Costa, Los Angeles, Marin,
Orange, Sacramento, San Francisco, San
Mateo, Santa Clara, Kern, Merced,
Monterey, Napa, San Benito, San
Joaquin, San Luis Obispo, Santa Cruz,
Solano, Stanislaus, and Ventura, are
designated a Purchased/Referred Care
(PRC) Service Delivery Area, formerly
referred to as a Contract Health Service
Delivery Area, by statute. The current
Service Delivery Area for the Tolowa
Dee-ni’ Nation Tribal members is the
statutorily established California PRC
Service Delivery Area. The expanded
PRC Service Delivery Area for the
Tolowa Dee-ni’ Nation includes the
statutorily established California PRC
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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16:31 Mar 30, 2017
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Service Delivery Area and Curry County
in the State of Oregon.
DATES: Comments must be submitted
May 1, 2017.
ADDRESSES: In commenting, please refer
to the title of this notice. Because of staff
and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission. You may submit
comments in one of four ways (please
choose only one of the ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the ‘‘Submit a Comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address ONLY: Evonne Bennett-Barnes,
Indian Health Service, 5600 Fishers
Lane, Mailstop: 09E70, Rockville,
Maryland 20852.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
above address.
4. By hand or courier. If you prefer,
you may deliver (by hand or courier)
your written comments before the close
of the comment period to the address
above.
If you intend to deliver your
comments to the Rockville address,
please call telephone number (301) 443–
1116 in advance to schedule your
arrival with a staff member.
Comments will be made available for
public inspection at the Rockville
address from 8:30 a.m. to 5:00 p.m.,
Monday–Friday, two weeks after
publication of this notice.
FOR FURTHER INFORMATION CONTACT:
Terri Schmidt, Acting Director, Office of
Resource Access and Partnerships,
Indian Health Service, 5600 Fishers
Lane, Mailstop: 10E85C, Rockville,
Maryland 20852. Telephone 301/443–
2694 (This is not a toll free number).
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment.
Background: The IHS currently
provides services under regulations
codified at 42 CFR part 136, subparts A
through C. Subpart C defines a Contract
Health Service Delivery Area, now
known as PRC Service Delivery Area, as
the geographic area within which PRC
will be made available by the IHS to
members of an identified Indian
community who reside in the Service
Delivery Area. Potential eligibility for
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Fmt 4703
Sfmt 4703
16045
services alone, or residence in a PRC
Service Delivery Area by a person who
is within the scope of the Indian health
program, as set forth in 42 CFR 136.12,
does not create a legal entitlement to
PRC. Services needed, but not available
at an IHS/Tribal facility, are provided
under the PRC program depending on
the availability of funds, the person’s
relative medical priority, and the actual
availability and accessibility of alternate
resources in accordance with the
regulations.
As applicable to the Tribes, these
regulations provide that, unless
otherwise designated, a PRC Service
Delivery Area shall consist of a county
which includes all or part of a
reservation and any county or counties
which have a common boundary with
the reservation, 42 CFR 136.22(a)(6)
(2016). The regulations also provide that
after consultation with the Tribal
governing body or bodies on those
reservations included within the PRC
Service Delivery Area, the Secretary
may from time to time, re-designate
areas within the United States for
inclusion in or exclusion from a PRC
Service Delivery Area. The regulations
require that certain criteria must be
considered before any re-designation is
made. The criteria are as follows:
(1) The number of Indians residing in
the area proposed to be so included or
excluded;
(2) Whether the Tribal governing body
has determined that Indians residing in
the area near the reservation are socially
and economically affiliated with the
Tribes;
(3) The geographic proximity to the
reservation of the area whose inclusion
or exclusion is being considered; and
(4) The level of funding which would
be available for the provision of PRC.
Additionally, the regulations require
that any re-designation of a PRC Service
Delivery Area must be made in
accordance with the Administrative
Procedures Act (5 U.S.C. 553). In
compliance with this requirement, we
are publishing this proposal and
requesting public comments.
Congress designated the entire state of
California as a PRC Service Delivery
Area, excluding certain counties, under
section 810 of the Indian Healthcare
Improvement Act, Public Law 94–437,
as amended (25 U.S.C. 1680). IHS has
utilized the congressionally established
PRC Service Delivery Area for the
purposes of administering PRC benefits
to members of the Tribe. Thus, members
of the Tribe who reside outside of the
statutorily established California PRC
Service Delivery Area do not reside
within the Tolowa Dee-ni’s current PRC
E:\FR\FM\31MRN1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 61 (Friday, March 31, 2017)]
[Notices]
[Pages 16044-16045]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-06370]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0001]
Roadmap for Engaging With the Food and Drug Administration's
Center for Drug Evaluation and Research; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA's) Center for Drug
Evaluation and Research (CDER), is announcing the following public
workshop entitled ``Roadmap for Engaging with FDA's Center for Drug
Evaluation and Research (CDER).'' The purpose of this workshop is to
help the public learn how to successfully engage with CDER.
DATES: The public workshop will be held on May 12, 2017, from 9 a.m. to
3 p.m.
ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20903-0002. Entrance for the public
workshop participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For parking and
security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
FOR FURTHER INFORMATION CONTACT: Chris Melton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-7381, NAV-CDER@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing a public workshop entitled ``Roadmap for Engaging
with FDA's Center for Drug Evaluation and Research (CDER).'' This
workshop is intended to help the public learn the most effective ways
to successfully engage with CDER. There will be presentations on
learning about the drug approval process, as well as the opportunity
for questions and answers following each presentation.
II. Participating in the Public Workshop
Registration: Persons interested in attending this workshop must
register online at https://www.eventbrite.com/e/fda-public-workshop-roadmap-for-engaging-with-fdas-center-for-drug-evaluation-and-research-cder-tickets-28608664285?utm_source=eb_email&utm_medium=email&utm_campaign=new_event_email&utm_term=viewmyevent_button. Please provide complete contact
information for each attendee, including name, title, affiliation,
address, email and telephone.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by May 5, 2016, 6 p.m. EST. Early registration
is recommended because seating is limited; therefore, FDA may limit the
number of participants from each organization. If time and space
permit, onsite registration on the day of the public workshop will be
provided beginning at 8 a.m. We will let registrants know if
registration closes before the day of the public workshop.
If you need special accommodations due to a disability, please
contact Chris Melton no later than May 1, 2017.
[[Page 16045]]
Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be assessable at https://www.regulations.gov. It may be viewed at the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. A transcript will also be available in
either hardcopy or on CD-ROM, after submission of a Freedom of
Information request. The Freedom of Information office address is
available on the Agency's Web site at https://www.fda.gov.
Dated: March 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-06370 Filed 3-30-17; 8:45 am]
BILLING CODE 4164-01-P
