Behind the Counter Availability of Certain Drugs; Public Meeting; Comment Period Clarification, 66180-66181 [E7-23026]
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66180
Federal Register / Vol. 72, No. 227 / Tuesday, November 27, 2007 / Notices
the needs of children and families in
EHS programs, and how children and
families in EHS programs progress over
time.
The activity proposed under this
notice includes only the data collected
during the selection and recruitment of
programs to participate in DSEHS and a
pilot study on the feasibility of
proposed measures.
To select and recruit programs, ACF
intends to send letters to program
directors of selected EHS programs.
Directors will receive a summary of the
study goals that will include an
overview of the design and data
collection, a brochure describing the
study, and examples of the consent
materials for enrolling study
participants. Programs will not be asked
to enroll participants during the initial
selection and recruitment phase.
Selected programs may also receive a
follow-up phone call to answer
questions from EHS directors or staff.
Program directors will be asked to
provide information on the numbers of
families enrolled with children who
will be within two months of the target
ages at the time of each of the four fall
data collections.
ACF intends to conduct a feasibility
pilot study at two EHS programs in June
2008. In the pilot study, ACF will test
the feasibility of administering various
direct child assessment measures and
parent interviews.
Respondents: EHS Program Directors,
Parents, and Children.
ANNUAL BURDEN ESTIMATES
Annual number of respondents
Instrument
pwalker on PROD1PC71 with NOTICES
Recruitment materials sent to program sites ...................................................
Program roster of children in target ages ........................................................
Pilot Test—Child Assessment .........................................................................
Pilot Test—Parent Interview ............................................................................
Estimated Total Annual Burden
Hours: 125.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on (a) whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
VerDate Aug<31>2005
17:26 Nov 26, 2007
Jkt 214001
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0356]
Behind the Counter Availability of
Certain Drugs; Public Meeting;
Comment Period Clarification
Food and Drug Administration,
HHS.
Notice; comment period
clarification.
ACTION:
SUMMARY: In the Federal Register of
October 4, 2007 (72 FR 56769), the Food
and Drug Administration (FDA)
published a notice that announced a
public meeting to obtain comments
regarding behind-the-counter (BTC)
availability of human drugs. An
incorrect date was published in that
notice. This document clarifies that
Docket No. 2007N–0356 will close on
December 17, 2007.
ADDRESSES: You may submit comments,
identified by Docket No. 2007N–0356,
by any of the following methods:
Electronic Submissions
Submit electronic comments in the
following ways:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Agency Web site: https://
www.fda.gov/dockets/ecomments.
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
Average burden hours per
response
Estimated annual burden
hours
1
1
1
1
.25
.50
1.0
1.0
15
30
40
40
60
60
40
40
Dated: November 20, 2007.
Brendan C. Kelly,
OPRE Reports Clearance Officer.
[FR Doc. 07–5842 Filed 11–26–07; 8:45 am]
AGENCY:
Number of responses per
respondent
Follow the instructions for submitting
comments on the agency Web site.
Written Submissions
Submit written registration and
comments in the following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier (for
paper, disk, or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
To ensure more timely processing of
comments, FDA is no longer accepting
comments submitted to the agency by email. FDA encourages you to continue
to submit electronic comments by using
the Federal eRulemaking Portal or the
agency Web site, as described
previously, in the ADDRESSES portion of
this document under Electronic
Submissions.
Instructions: All submissions received
must include the agency name and
docket number for this notice. All
comments received may be posted
without change to https://www.fda.gov/
ohrms/dockets/default.htm, including
any personal information provided. For
additional information on submitting
comments, see the ‘‘Comments’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.fda.gov/ohrms/dockets/
default.htm 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.
E:\FR\FM\27NON1.SGM
27NON1
Federal Register / Vol. 72, No. 227 / Tuesday, November 27, 2007 / Notices
Transcripts of the meeting will be
available for review at the Division of
Dockets Management and on the
Internet at https://www.fda.gov/ohrms/
dockets approximately 30 days after the
meeting.
FOR FURTHER INFORMATION CONTACT: Erik
Mettler, Office of Policy (HF–11), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
3360, FAX: 301–594–6777
Erik.Mettler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
pwalker on PROD1PC71 with NOTICES
I. Background
In the Federal Register of October 4,
2007 (72 FR 56769), FDA announced
that it would hold a public meeting
regarding BTC availability of certain
human drugs. BTC availability could
make certain drugs available behind the
counter at the pharmacy without a
prescription and require the
intervention of a pharmacist before
dispensing.
Some groups have asserted that
pharmacist interaction with the
consumer could ensure safe and
effective use of a drug product that
otherwise might require a prescription.
Because pharmacists have the training
and knowledge to provide certain
interventions, they may be able to
ensure that patients meet the conditions
for use and educate patients on
appropriate use of the drug product.
These groups have suggested that the
availability of certain drugs BTC could
increase patient access to medications
that may be underutilized, particularly
by patients without health insurance,
because these medications otherwise
would be available only with a
prescription.
The Federal Register notice stated
that interested persons would be able to
submit comments to the Division of
Dockets Management and that the
public docket would remain open for 30
days following the meeting. Our intent
was to state that the docket would
remain open until December 17, 2007
(30 days after the meeting, which
occurred on November 14, 2007).
However, the notice also instructed
persons to register if they wished to
attend or participate in the meeting; the
instructions stated that registration
would occur on a first-come, first-serve
basis, but then mistakenly declared that
written or electronic comments would
be accepted ‘‘until November 28, 2007’’
(72 FR 56769).
II. Comments
This notice clarifies that we will
accept comments to the public docket
until December 17, 2007.
VerDate Aug<31>2005
17:26 Nov 26, 2007
Jkt 214001
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that in January 2008, the
FDA Web site is expected to transition
to the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. After the transition
date, electronic submissions will be
accepted by FDA through the FDMS
only. When the exact date of the
transition to FDMS is known, FDA will
publish a Federal Register notice
announcing that date.
Dated: November 20, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7–23026 Filed 11–26–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program: Revised Amount of the
Average Cost of a Health Insurance
Policy
The Health Resources and Services
Administration is publishing an
updated monetary amount of the
average cost of a health insurance policy
as it relates to the National Vaccine
Injury Compensation Program (VICP).
Pursuant to section 100.2 of the
VICP’s implementing regulations (42
CFR Part 100), the Secretary announces
that the revised average cost of a health
insurance policy under the VICP is
$380.04 per month. In accordance with
§ 100.2, the revised amount was
effective upon its delivery by the
Secretary to the United States Court of
Federal Claims. Such notice was
delivered to the Court on October 17,
2007.
Dated: November 19, 2007.
Elizabeth M. Duke,
Administrator.
[FR Doc. E7–23090 Filed 11–26–07; 8:45 am]
BILLING CODE 4165–15–P
PO 00000
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66181
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
HIV/AIDS Bureau; Ryan White HIV/
AIDS Program Core Medical Services
Waiver Application Requirements
Health Resources and Services
Administration (HRSA), HHS.
ACTION: Notice of opportunity to provide
written comments.
AGENCY:
SUMMARY: This notice solicits comments
on the HRSA proposed uniform waiver
standards for Ryan White HIV/AIDS
Program grantees requesting a core
medical services waiver for Fiscal Year
2008 and beyond. Title XXVI of the
Public Health Service Act (PHS) Act, as
amended by the Ryan White HIV/AIDS
Treatment Modernization Act of 2006
(Ryan White HIV/AIDS Program)
requires that grantees expend 75 percent
of Parts A, B, and C funds on core
medical services, including
antiretroviral drugs, for individuals with
HIV/AIDS identified and eligible under
the legislation, effective Fiscal Year (FY)
2007. HRSA has issued guidance for
obtaining a waiver for FY 2007 and
seeks to issue waiver requirements for
grantees under Parts A, B, and C of Title
XXVI of the PHS Act for FY 2008 and
future years.
DATES: Written comments must be
received no later than 30 days after date
of publication in the Federal Register.
ADDRESSES: Written comments should
be sent to HRSA, HAB, Division of
Science and Policy, Attention: LCDR
Gettie A. Butts, 5600 Fishers Lane,
Room 7–18, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT:
LCDR Gettie A. Butts, at:
GButts@hrsa.gov or by writing to the
address above.
SUPPLEMENTARY INFORMATION: The
statute, Title XXVI of the Public Health
Service Act (PHS) Act, as amended by
the Ryan White HIV/AIDS Treatment
Modernization Act of 2006, imposes two
criteria for waiver eligibility: (1) No
waiting lists for AIDS Drug Assistance
Program (ADAP) services; and (2) core
medical services availability within the
relevant service area to all individuals
with HIV/AIDS identified and eligible
under Title XXVI of the PHS Act. See
sections 2604(c)(2), 2612(b)(2), and
2651(c)(2) of the PHS Act. The Health
Resources and Services Administration
(HRSA) HIV/AIDS Bureau has issued
interim waiver eligibility guidance for
FY 2007 to provide immediate
implementation of these waiver
provisions. The FY 2007 guidance
E:\FR\FM\27NON1.SGM
27NON1
]]>Agencies
[Federal Register Volume 72, Number 227 (Tuesday, November 27, 2007)]
[Notices]
[Pages 66180-66181]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-23026]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0356]
Behind the Counter Availability of Certain Drugs; Public Meeting;
Comment Period Clarification
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; comment period clarification.
-----------------------------------------------------------------------
SUMMARY: In the Federal Register of October 4, 2007 (72 FR 56769), the
Food and Drug Administration (FDA) published a notice that announced a
public meeting to obtain comments regarding behind-the-counter (BTC)
availability of human drugs. An incorrect date was published in that
notice. This document clarifies that Docket No. 2007N-0356 will close
on December 17, 2007.
ADDRESSES: You may submit comments, identified by Docket No. 2007N-
0356, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: https://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
Submit written registration and comments in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described previously, in
the ADDRESSES portion of this document under Electronic Submissions.
Instructions: All submissions received must include the agency name
and docket number for this notice. All comments received may be posted
without change to https://www.fda.gov/ohrms/dockets/default.htm,
including any personal information provided. For additional information
on submitting comments, see the ``Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.fda.gov/ohrms/dockets/default.htm
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.
[[Page 66181]]
Transcripts of the meeting will be available for review at the
Division of Dockets Management and on the Internet at https://
www.fda.gov/ohrms/dockets approximately 30 days after the meeting.
FOR FURTHER INFORMATION CONTACT: Erik Mettler, Office of Policy (HF-
11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-3360, FAX: 301-594-6777 Erik.Mettler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 4, 2007 (72 FR 56769), FDA
announced that it would hold a public meeting regarding BTC
availability of certain human drugs. BTC availability could make
certain drugs available behind the counter at the pharmacy without a
prescription and require the intervention of a pharmacist before
dispensing.
Some groups have asserted that pharmacist interaction with the
consumer could ensure safe and effective use of a drug product that
otherwise might require a prescription. Because pharmacists have the
training and knowledge to provide certain interventions, they may be
able to ensure that patients meet the conditions for use and educate
patients on appropriate use of the drug product. These groups have
suggested that the availability of certain drugs BTC could increase
patient access to medications that may be underutilized, particularly
by patients without health insurance, because these medications
otherwise would be available only with a prescription.
The Federal Register notice stated that interested persons would be
able to submit comments to the Division of Dockets Management and that
the public docket would remain open for 30 days following the meeting.
Our intent was to state that the docket would remain open until
December 17, 2007 (30 days after the meeting, which occurred on
November 14, 2007). However, the notice also instructed persons to
register if they wished to attend or participate in the meeting; the
instructions stated that registration would occur on a first-come,
first-serve basis, but then mistakenly declared that written or
electronic comments would be accepted ``until November 28, 2007'' (72
FR 56769).
II. Comments
This notice clarifies that we will accept comments to the public
docket until December 17, 2007.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Please note that in January 2008, the FDA Web site is expected to
transition to the Federal Dockets Management System (FDMS). FDMS is a
Government-wide, electronic docket management system. After the
transition date, electronic submissions will be accepted by FDA through
the FDMS only. When the exact date of the transition to FDMS is known,
FDA will publish a Federal Register notice announcing that date.
Dated: November 20, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-23026 Filed 11-26-07; 8:45 am]
BILLING CODE 4160-01-S
