New Methodology and Increase in Low Income Levels for Various Health Professions and Nursing Training and Assistance Programs, 8381-8382 [05-3175]
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Federal Register / Vol. 70, No. 33 / Friday, February 18, 2005 / Notices
Dated: February 10, 2005.
Jeffrey Shuren,
Associate Commissioner for Policy.
[FR Doc. 05–3221 Filed 2–17–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0057]
Reviewer Guidance on Conducting a
Clinical Safety Review of a New
Product Application and Preparing a
Report on the Review; Availability
AGENCY: Food and Drug Administration,
HHS.
ACTION: Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a reviewer guidance
entitled ‘‘Conducting a Clinical Safety
Review of a New Product Application
and Preparing a Report on the Review.’’
The guidance is intended to provide an
annotated outline of the safety
component of a clinical review of a new
drug or biologic product application and
guidance on how to conduct and
organize the safety review. The
guidance is also intended to provide
standardization and consistency in the
format, content, and quality of safety
reviews. This reviewer guidance has
been developed as part of the agency’s
good review practices initiative.
DATES: General comments on agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Robert Temple, Center for Drug
Evaluation and Research (HFD–40),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–594–6758.
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15:41 Feb 17, 2005
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SUPPLEMENTARY INFORMATION: This good
review practice (GRP) guidance is
intended to assist reviewers conducting
clinical safety reviews as part of the new
drug application (NDA) and biologics
license application (BLA) review
process. The guidance provides
standardization and consistency in the
format and content of safety reviews and
will help ensure that critical
presentations and analyses are not
inadvertently omitted. The standardized
structure of this guidance will enable
subsequent reviewers and other readers
to readily locate specific safety
information. This guidance is entirely
compatible with the clinical review
template, which has been developed in
the Center for Drug Evaluation and
Research for use by application
reviewers. The guidance is structured as
an annotated outline to corrolate exactly
with the section headings of the review
template, providing the pertinent
guidance under each heading. The
commentary and suggestions under each
section of the guidance, together with
appended examples, provide suggested
analyses, methods of presentations, and
discussion of special cases and potential
difficulties.
In 1996, FDA announced the
availability of the draft version of this
guidance. A number of comments were
received, and the agency considered
them carefully as it finalized the
guidance. The changes that were made
to the guidance were intended primarily
to make it consistent with the template
reviewers are using to evaluate
marketing applications. Some minor
clarifying changes also were made.
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on this topic. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statute and regulations.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the guidance at any time.
Two copies of mailed comments are to
be submitted, except that individuals
may submit one copy. Comments are to
be identified with the docket number
found in brackets in the heading of this
document. The guidance and received
comments are available for public
examination in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Persons with access to the Internet
may obtain the guidance at either
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8381
https://www.fda.gov/cder/guidance/
index.htm or https://www.fda.gov/
ohrms/dockets/default.htm.
Dated: February 10, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–3181 Filed 2–17–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
New Methodology and Increase in Low
Income Levels for Various Health
Professions and Nursing Training and
Assistance Programs
AGENCY: Health Resources and Services
Administration (HRSA), HHS.
ACTION: Notice.
SUMMARY: HRSA uses ‘‘low-income’’
levels to determine whether an
individual is from an economically
disadvantaged background in making
eligibility and funding determinations
for participants in various health
professions and nursing grant and
cooperative agreement programs
authorized by Titles III, VII and VIII of
the Public Health Service (PHS) Act. In
the past, an individual’s economically
disadvantaged background status, as a
basis for participation in certain
programs, was based on the income
level of the individual’s parents.
However, many potential program
participants are well above the age of
majority. Accordingly, questions have
been raised by potential program
participants and program officials
regarding the feasibility and fairness in
determining economically
disadvantaged status based solely on the
parent’s income. This notice updates the
low-income levels published by HRSA
on August 5, 2003 (68 FR 46199–46200),
and changes the methodology used to
determine low income for use in these
programs beginning in Fiscal Year (FY)
2005.
SUPPLEMENTARY INFORMATION: HRSA
publishes low-income levels of families
(68 FR 46199–46200, 8/5/03) for the use
of various health professions training
and assistance programs funded under
Titles III, VII, and VIII of the PHS Act
in making eligibility and funding
determinations for participants in the
programs. HRSA establishes these lowincome levels based on the poverty
guidelines that HHS publishes annually
in the Federal Register (68 FR 7336,
2/13/2004). HHS determines the poverty
guidelines based on the poverty
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18FEN1
8382
Federal Register / Vol. 70, No. 33 / Friday, February 18, 2005 / Notices
thresholds established by the U.S.
Census Bureau, adjusted annually for
changes in the Consumer Price Index.
For FY 2005, HRSA has determined
that:
• ‘‘Low-income level’’ as applied to a
family is one with an annual income
that is below 200 percent of HHS’s
poverty guidelines, as indicated in the
table below, and
• A family is a group of two or more
individuals related by birth, marriage, or
adoption who live together or an
individual who is not living with any
relatives.
FY 2005 LOW INCOME LEVELS
Income
level 2
Persons in family 1
1
2
3
4
5
6
7
8
................................................
................................................
................................................
................................................
................................................
................................................
................................................
................................................
$18,620
24,980
31,340
37,700
44,060
50,420
56,780
63,140
1 Includes only dependents reported on Federal Income tax forms for calendar year 2003.
2 Adjusted gross income for calendar year
2003.
New Methodology: Beginning in FY
2005, various programs in HRSA will
use a new methodology in the
application of low-income levels.
Depending on the legislative intent of
the program, the programmatic purpose
of the low income level, as well as the
age and circumstances of the average
participant, each program will either
apply the low-income levels to the
family of the individual participant or to
the family of the parents of the
individual participant. Each program
will announce the rationale and choice
of methodology for determining low
income levels in their program
guidance.
Dated: February 11, 2005.
Elizabeth M. Duke,
Administrator.
[FR Doc. 05–3175 Filed 2–17–05; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
AGENCY: Health Resources and Services
Administration, HHS.
ACTION: Notice.
VerDate jul<14>2003
15:41 Feb 17, 2005
Jkt 205001
SUMMARY: The Health Resources and
Services Administration (HRSA) is
publishing this notice of petitions
received under the National Vaccine
Injury Compensation Program (‘‘the
Program’’), as required by Section
2112(b)(2) of the Public Health Service
(PHS) Act, as amended. While the
Secretary of Health and Human Services
is named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the Program in
general, contact the Clerk, United States
Court of Federal Claims, 717 Madison
Place, NW., Washington, DC 20005,
(202) 219–9657. For information on
HRSA’s role in the Program, contact the
Acting Director, National Vaccine Injury
Compensation Program, 5600 Fishers
Lane, Room 11C–26, Rockville, MD
20857; (301) 443–6593.
SUPPLEMENTARY INFORMATION: The
Program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
compensation are to file a petition with
the U.S. Court of Federal Claims and to
serve a copy of the petition on the
Secretary of Health and Human
Services, who is named as the
respondent in each proceeding. The
Secretary has delegated his
responsibility under the Program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
appropriate, and make initial decisions
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
vaccines described in the Vaccine Injury
Table (the Table) set forth at Section
2114 of the PHS Act or as set forth at
42 CFR 100.3, as applicable. This Table
lists for each covered childhood vaccine
the conditions which will lead to
compensation and, for each condition,
the time period for occurrence of the
first symptom or manifestation of onset
or of significant aggravation after
vaccine administration. Compensation
may also be awarded for conditions not
listed in the Table and for conditions
that are manifested outside the time
periods specified in the Table, but only
if the petitioner shows that the
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condition was caused by one of the
listed vaccines.
Section 2112(b)(2) of the PHS Act, 42
U.S.C. 300aa–12(b)(2), requires that the
Secretary publish in the Federal
Register a notice of each petition filed.
Set forth below is a list of petitions
received by HRSA on April 1, 2004,
through June 30, 2004.
Section 2112(b)(2) also provides that
the special master ‘‘shall afford all
interested persons an opportunity to
submit relevant, written information’’
relating to the following:
1. The existence of evidence ‘‘that
there is not a preponderance of the
evidence that the illness, disability,
injury, condition, or death described in
the petition is due to factors unrelated
to the administration of the vaccine
described in the petition,’’ and
2. Any allegation in a petition that the
petitioner either:
(a) ‘‘Sustained, or had significantly
aggravated, any illness, disability,
injury, or condition not set forth in the
Table but which was caused by’’ one of
the vaccines referred to in the Table, or
(b) ‘‘Sustained, or had significantly
aggravated, any illness, disability,
injury, or condition set forth in the
Vaccine Injury Table the first symptom
or manifestation of the onset or
significant aggravation of which did not
occur within the time period set forth in
the Table but which was caused by a
vaccine’’ referred to in the Table.
This notice will also serve as the
special master’s invitation to all
interested persons to submit written
information relevant to the issues
described above in the case of the
petitions listed below. Any person
choosing to do so should file an original
and three (3) copies of the information
with the Clerk of the U.S. Court of
Federal Claims at the address listed
above (under the heading FOR FURTHER
INFORMATION CONTACT), with a copy to
HRSA addressed to Acting Director,
Division of Vaccine Injury
Compensation Program, Healthcare
Systems Bureau, 5600 Fishers Lane,
Room 11C–26, Rockville, MD 20857.
The Court’s caption (Petitioner’s Name
v. Secretary of Health and Human
Services) and the docket number
assigned to the petition should be used
as the caption for the written
submission. Chapter 35 of title 44,
United States Code, related to
paperwork reduction, does not apply to
information required for purposes of
carrying out the Program.
List of Petitions
1. Jennifer and Mark Chung on behalf of
Gabrielle Chung
Houston, Texas
E:\FR\FM\18FEN1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 33 (Friday, February 18, 2005)]
[Notices]
[Pages 8381-8382]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-3175]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
New Methodology and Increase in Low Income Levels for Various
Health Professions and Nursing Training and Assistance Programs
AGENCY: Health Resources and Services Administration (HRSA), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: HRSA uses ``low-income'' levels to determine whether an
individual is from an economically disadvantaged background in making
eligibility and funding determinations for participants in various
health professions and nursing grant and cooperative agreement programs
authorized by Titles III, VII and VIII of the Public Health Service
(PHS) Act. In the past, an individual's economically disadvantaged
background status, as a basis for participation in certain programs,
was based on the income level of the individual's parents. However,
many potential program participants are well above the age of majority.
Accordingly, questions have been raised by potential program
participants and program officials regarding the feasibility and
fairness in determining economically disadvantaged status based solely
on the parent's income. This notice updates the low-income levels
published by HRSA on August 5, 2003 (68 FR 46199-46200), and changes
the methodology used to determine low income for use in these programs
beginning in Fiscal Year (FY) 2005.
SUPPLEMENTARY INFORMATION: HRSA publishes low-income levels of families
(68 FR 46199-46200, 8/5/03) for the use of various health professions
training and assistance programs funded under Titles III, VII, and VIII
of the PHS Act in making eligibility and funding determinations for
participants in the programs. HRSA establishes these low-income levels
based on the poverty guidelines that HHS publishes annually in the
Federal Register (68 FR 7336, 2/13/2004). HHS determines the poverty
guidelines based on the poverty
[[Page 8382]]
thresholds established by the U.S. Census Bureau, adjusted annually for
changes in the Consumer Price Index.
For FY 2005, HRSA has determined that:
``Low-income level'' as applied to a family is one with an
annual income that is below 200 percent of HHS's poverty guidelines, as
indicated in the table below, and
A family is a group of two or more individuals related by
birth, marriage, or adoption who live together or an individual who is
not living with any relatives.
FY 2005 Low Income Levels
------------------------------------------------------------------------
Income
Persons in family \1\ level \2\
------------------------------------------------------------------------
1.......................................................... $18,620
2.......................................................... 24,980
3.......................................................... 31,340
4.......................................................... 37,700
5.......................................................... 44,060
6.......................................................... 50,420
7.......................................................... 56,780
8.......................................................... 63,140
------------------------------------------------------------------------
\1\ Includes only dependents reported on Federal Income tax forms for
calendar year 2003.
\2\ Adjusted gross income for calendar year 2003.
New Methodology: Beginning in FY 2005, various programs in HRSA
will use a new methodology in the application of low-income levels.
Depending on the legislative intent of the program, the programmatic
purpose of the low income level, as well as the age and circumstances
of the average participant, each program will either apply the low-
income levels to the family of the individual participant or to the
family of the parents of the individual participant. Each program will
announce the rationale and choice of methodology for determining low
income levels in their program guidance.
Dated: February 11, 2005.
Elizabeth M. Duke,
Administrator.
[FR Doc. 05-3175 Filed 2-17-05; 8:45 am]
BILLING CODE 4165-15-P
