Pediatric Rare Diseases-A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance for Industry; Availability; Correction, 45769 [2019-18730]
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Federal Register / Vol. 84, No. 169 / Friday, August 30, 2019 / Notices
until the new IC is approved and ready
for usage.
The Older Americans Act (OAA)
requires annual program performance
reports from States, the District of
Columbia, and Territories. In
compliance with this OAA provision,
ACL developed a SPR in 1996 as part of
its National Aging Program Information
System (NAPIS). The SPR collects
information about how State Agencies
on Aging expend their OAA funds as
well as funding from other sources for
OAA authorized supportive services.
The SPR also collects information on
the demographic and functional status
of the recipients, and is a key source for
ACL performance measurement. The
information submitted by Title III
grantees is AoA’s principle source for
data and information on programs and
services funded under the Older
Americans Act (OAA). The SPR serves
as the Program Performance Report for
the state grantees to meet their annual
grantee reporting requirements and
includes the data required by the OAA
be reported in the AoA Annual Report
to Congress. This IC is summary data of
services for seniors provided or
managed by State Units on Aging (SUA)
and Area Agencies on Aging (AAA).
Data is submitted annually by the 50
states, four Territories (American
Samoa, Guam, Puerto Rico, and Virgin
Islands), and Washington, DC. The SPR
includes information on the number of
people served, the number of units of
specific services, Title III expenditures,
total expenditures, number of state and
local staff, number of providers, and
major accomplishments.
Data from the SPR are the primary
source for performance measures in the
Congressional budget justification, the
HHS Annual Performance Plan and
Report as well as the Annual Report to
Congress.
Respondent/data
collection activity
Estimated Program Burden
ACL estimates the burden associated
with this collection of information as
follows: 2,750 annual burden hours.
Responses
per
respondent
Hours per
response
Annual
burden hours
SPR ..................................................................................................................
55
1
50
2,750
Total ..........................................................................................................
55
1
50
2,750
Dated: August 20, 2019.
Mary Lazare,
Principal Deputy Administrator.
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2017–D–2991]
Pediatric Rare Diseases—A
Collaborative Approach for Drug
Development Using Gaucher Disease
as a Model; Draft Guidance for
Industry; Availability; Correction
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration is correcting a notice
entitled ‘‘Pediatric Rare Diseases—A
Collaborative Approach for Drug
Development Using Gaucher Disease as
a Model; Draft Guidance for Industry;
Availability’’ that appeared in the
Federal Register of December 7, 2017.
The document announced the
availability of a draft guidance focusing
on drug development for pediatric
patients with Gaucher disease. The
document was published with the
SUMMARY:
VerDate Sep<11>2014
16:43 Aug 29, 2019
Jkt 247001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Lisa
Granger, Office of Policy, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 3330, Silver Spring,
MD 20993–0002, 301–796–9115.
Food and Drug Administration
In the
Federal Register of Thursday, December
7, 2017 (82 FR 57759), in FR Doc. 2017–
26357, the following correction is made:
On page 57759, in the first column, in
the document heading and in the third
column under Instructions, the docket
number ‘‘FDA–2017–N–6476’’ is
corrected to read ‘‘FDA–2017–D–2991’’.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
AGENCY:
incorrect docket number. This
document corrects that error.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2019–18842 Filed 8–29–19; 8:45 am]
jspears on DSK3GMQ082PROD with NOTICES
Number of
respondents
AoA also uses the data to respond to
inquiries from stakeholders, the public,
press, program and policy decision
makers. Information from the most
recent SPR is available on-line on the
Aging Integrated Database (AGID).
Results are available annually.
The proposed FY 2020 version posts
on the ACL website link entitled
Proposed State Program Report (SPR)
Form 2020 Revision available at https://
acl.gov/programs/performance-olderamericans-act-programs
For review and comment on this
proposed information collection
request, please visit the ACL website
https://www.acl.gov/about-acl/publicinput.
Dated: August 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–18730 Filed 8–29–19; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
[Docket Nos. FDA–2018–E–0699 and FDA–
2018–E–0705]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; NERLYNX
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for NERLYNX and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
SUMMARY:
Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by October 29, 2019.
Furthermore, any interested person may
DATES:
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]]>Agencies
[Federal Register Volume 84, Number 169 (Friday, August 30, 2019)]
[Notices]
[Page 45769]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18730]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-2991]
Pediatric Rare Diseases--A Collaborative Approach for Drug
Development Using Gaucher Disease as a Model; Draft Guidance for
Industry; Availability; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration is correcting a notice
entitled ``Pediatric Rare Diseases--A Collaborative Approach for Drug
Development Using Gaucher Disease as a Model; Draft Guidance for
Industry; Availability'' that appeared in the Federal Register of
December 7, 2017. The document announced the availability of a draft
guidance focusing on drug development for pediatric patients with
Gaucher disease. The document was published with the incorrect docket
number. This document corrects that error.
FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330,
Silver Spring, MD 20993-0002, 301-796-9115.
SUPPLEMENTARY INFORMATION: In the Federal Register of Thursday,
December 7, 2017 (82 FR 57759), in FR Doc. 2017-26357, the following
correction is made:
On page 57759, in the first column, in the document heading and in
the third column under Instructions, the docket number ``FDA-2017-N-
6476'' is corrected to read ``FDA-2017-D-2991''.
Dated: August 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18730 Filed 8-29-19; 8:45 am]
BILLING CODE 4164-01-P
