Privacy Act of 1974, as Amended; Computer Matching Program, 40128-40129 [06-6226]
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40128
Federal Register / Vol. 71, No. 135 / Friday, July 14, 2006 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Number of
responses per
respondent
Number of
respondents
Instrument
Average
burden hours
per response
Total burden
hours
Mother-Child Interaction ...........................................................................
Teacher Questionnaire .............................................................................
1,900
950
1
1
0.25
0.50
475
475
Year 2 Total .......................................................................................
Year 3 (2009):
Parent Interview ........................................................................................
Child Assessment .....................................................................................
Child Interview ..........................................................................................
Mother-Child Interaction ...........................................................................
Teacher Questionnaire .............................................................................
5,700
........................
........................
3,240
380
380
380
760
380
1
1
1
1
1
1.00
1.16
0.25
0.25
0.50
380
441
95
190
190
Year 3 Total .......................................................................................
2,280
........................
........................
1,296
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Estimated Total Burden Hours: 6,480.
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.
Dated: July 10, 2006.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 06–6227 Filed 7–13–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Privacy Act of 1974, as Amended;
Computer Matching Program
ACF, HHS.
Notice of a computer matching
program.
AGENCY:
ACTION:
SUMMARY: In compliance with the
Privacy Act of 1974, as amended by
Pub. L. 100–503, the Computer
Matching and Privacy Protection Act of
1988, we are publishing a notice of a
computer matching program. The
purpose of this computer match is to
identify specific individuals who are
receiving benefits from the VA and also
receiving payments pursuant to various
benefit programs administered by both
HHS and Department of Agriculture.
ACF will facilitate this program on
behalf of the State Public Assistance
Agencies (SPAAs) that participate in the
Public Assistance Reporting Information
System (PARIS) for verification of
continued eligibility for public
assistance. The match will utilize
Department of Veterans Affairs (VA)
records and SPAA records.
DATES: ACF will file a report of the
subject matching program with the
Committee on Homeland Security and
Governmental Affairs of the Senate and
the Committee on Government Reform
of the House of Representatives, and the
Office of Information and Regulatory
Affairs within the Office of Management
and Budget (OMB). The dates for the
matching program will be effective as
indicated below.
ADDRESSES: Interested parties may
comment on this notice by writing to
the Director, Office of Financial
Services, Office of Administration, 370
L’Enfant Promenade, SW., Washington,
DC 20047. All comments received will
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be available for public inspection at this
address.
FOR FURTHER INFORMATION CONTACT:
Director, Office of Financial Services,
Office of Administration, 370 L’Enfant
Promenade, SW., Washington, DC
20047. Telephone Number (202) 401–
7237.
Pub. L.
100–503, the Computer Matching and
Privacy Protection Act of 1988,
amended the Privacy Act (5 U.S.C. 552a)
by adding certain protections for
individuals applying for and receiving
federal benefits. The law regulates the
use of computer matching by federal
agencies when records in a system of
records are matched with other federal,
state and local government records.
Federal agencies which provide or
receive records in computer matching
programs must:
1. Negotiate written agreements with
source agencies;
2. Provide notification to applicants
and beneficiaries that their records are
subject to matching;
3. Verify match findings before
reducing, suspending, or terminating an
individual’s benefits or payments;
4. Furnish detailed reports to
Congress and OMB; and,
5. Establish a Data Integrity Board that
must approve matching agreements.
This computer matching program
meets the requirements of Pub. L. 100–
503.
SUPPLEMENTARY INFORMATION:
Dated: June 21, 2006.
Curtis L. Coy,
Deputy Assistant Secretary for
Administration, ACF.
Notice of Computer Matching Program
A. Participating Agencies
VA and the SPAAs.
B. Purpose of the Match
To identify specific individuals who
are receiving benefits from VA and also
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Federal Register / Vol. 71, No. 135 / Friday, July 14, 2006 / Notices
receiving payments pursuant to HHS
and Department of Agriculture benefit
programs, and to verify their continued
eligibility for such benefits. SPAAs will
contact affected individuals and seek to
verify the information resulting from the
match before initiating any adverse
actions based on the match results.
C. Authority for Conducting the Match
The authority for conducting the
matching program is contained in
section 402(a)(6) of the Social Security
Act [42 U.S.C. 602(a)(6)].
D. Records To Be Matched
VA will disclose records from its
Privacy Act system of records entitled
‘‘Compensation, Pension, Education and
Rehabilitation Records.’’ (58 VA 21/22
first published at 41 FR 9294 (March 3,
1976), and last amended at 70 FR 34186
(June 13, 2005)). VA’s disclosure of
information for use in this computer
match is listed as a routine use in this
system of records.
VA, as the source agency, will prepare
electronic files containing the names
and other personal identifying data of
eligible veterans receiving benefits.
These records are matched
electronically against SPAA files
consisting of data regarding monthly
Medicaid, Temporary Assistance to
Needy Families (TANF), general
assistance, and Food Stamp
beneficiaries.
1. The electronic files provided by the
SPAAs will contain client names and
Social Security numbers (SSNs.)
2. The resulting output returned to the
SPAAs will contain personal identifiers,
including names, SSNs, employers,
current work or home addresses, etc.
jlentini on PROD1PC65 with NOTICES
E. Inclusive Dates of the Matching
Program
The effective date of the matching
agreement and date when matching may
actually begin shall be at the expiration
of the 40-day review period for OMB
and Congress, or 30 days after
publication of the matching notice in
the Federal Register, whichever date is
later. The matching program will be in
effect for 18 months from the effective
date, with an option to renew for 12
additional months, unless one of the
parties to the agreement advises the
others by written request to terminate or
modify the agreement.
[FR Doc. 06–6226 Filed 7–13–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2005P–0300 and 2005P–0319]
Determination That PHENERGAN
(Promethazine Hydrochloride) Tablets,
12.5 Milligrams and 50 Milligrams,
Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
that PHENERGAN (promethazine
hydrochloride (HCl)) tablets, 12.5
milligrams (mg) and 50 mg, were not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for promethazine
HCl tablets, 12.5 mg and 50 mg.
FOR FURTHER INFORMATION CONTACT:
Quynh Nguyen, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2041.
In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (the 1984
amendments) (Public Law 98–417),
which authorized the approval of
duplicate versions of drug products
approved under an ANDA procedure.
ANDA sponsors must, with certain
exceptions, show that the drug for
which they are seeking approval
contains the same active ingredient in
the same strength and dosage form as
the ‘‘listed drug,’’ which is a version of
the drug that was previously approved.
Sponsors of ANDAs do not have to
repeat the extensive clinical testing
otherwise necessary to gain approval of
a new drug application (NDA). The only
clinical data required in an ANDA are
data to show that the drug that is the
subject of the ANDA is bioequivalent to
the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is generally known as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are withdrawn from the list if the
agency withdraws or suspends approval
SUPPLEMENTARY INFORMATION:
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40129
of the drug’s NDA or ANDA for reasons
of safety or effectiveness or if FDA
determines that the listed drug was
withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
Under § 314.161(a)(1) (21 CFR
314.161(a)(1)), the agency must
determine whether a listed drug was
withdrawn from sale for reasons of
safety or effectiveness before an ANDA
that refers to that listed drug may be
approved. FDA may not approve an
ANDA that does not refer to a listed
drug.
PHENERGAN (promethazine HCl)
tablets, 12.5 mg and 50 mg, are the
subject of approved NDA 7–935 held by
Wyeth Pharmaceuticals, Inc. (Wyeth).
PHENERGAN (promethazine HCl)
tablets are indicated for, among other
things, certain types of allergic reactions
and sedation. Wyeth’s NDA 7–935 was
originally approved in 1951. In 1971,
under the Drug Efficacy Study
Implementation (DESI), FDA concluded
that promethazine HCl tablets were
effective or probably effective for the
indications described in the Federal
Register notice published on June 18,
1971 (DESI 6290, 36 FR 11758). Wyeth
discontinued sale of the 12.5 mg and 50
mg tablets in 2004. Amide
Pharmaceutical, Inc., and Peter S.
Reichertz submitted citizen petitions
dated July 28, 2005 (Docket No. 2005P–
0300/CP1), and August 10, 2005 (Docket
No. 2005P–0319/CP1), respectively,
under 21 CFR 10.30, requesting that the
agency determine, as described in
§ 314.161, whether PHENERGAN
(promethazine HCl) tablets, 12.5 mg and
50 mg, were withdrawn from sale for
reasons of safety or effectiveness.
The agency has determined that
Wyeth’s PHENERGAN (promethazine
HCl) tablets, 12.5 mg and 50 mg, were
not withdrawn from sale for reasons of
safety or effectiveness. In support of this
finding, we note that promethazine HCl
is a widely used product that has been
marketed for many decades in many
dosage forms. FDA has independently
evaluated relevant literature and data
for adverse event reports and has found
no information that would indicate that
PHENERGAN tablets, 12.5 mg and 50
mg, were withdrawn for reasons of
safety or effectiveness.
After considering the citizen petitions
(including comments submitted) and
reviewing agency records, FDA
determines that for the reasons outlined
previously, Wyeth’s PHENERGAN
(promethazine HCl) tablets, 12.5 mg and
50 mg, were not withdrawn from sale
for reasons of safety or effectiveness.
Accordingly, the agency will continue
to list PHENERGAN (promethazine HCl)
tablets, 12.5 mg and 50 mg, in the
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]]>Agencies
[Federal Register Volume 71, Number 135 (Friday, July 14, 2006)]
[Notices]
[Pages 40128-40129]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-6226]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Privacy Act of 1974, as Amended; Computer Matching Program
AGENCY: ACF, HHS.
ACTION: Notice of a computer matching program.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Privacy Act of 1974, as amended by Pub.
L. 100-503, the Computer Matching and Privacy Protection Act of 1988,
we are publishing a notice of a computer matching program. The purpose
of this computer match is to identify specific individuals who are
receiving benefits from the VA and also receiving payments pursuant to
various benefit programs administered by both HHS and Department of
Agriculture. ACF will facilitate this program on behalf of the State
Public Assistance Agencies (SPAAs) that participate in the Public
Assistance Reporting Information System (PARIS) for verification of
continued eligibility for public assistance. The match will utilize
Department of Veterans Affairs (VA) records and SPAA records.
DATES: ACF will file a report of the subject matching program with the
Committee on Homeland Security and Governmental Affairs of the Senate
and the Committee on Government Reform of the House of Representatives,
and the Office of Information and Regulatory Affairs within the Office
of Management and Budget (OMB). The dates for the matching program will
be effective as indicated below.
ADDRESSES: Interested parties may comment on this notice by writing to
the Director, Office of Financial Services, Office of Administration,
370 L'Enfant Promenade, SW., Washington, DC 20047. All comments
received will be available for public inspection at this address.
FOR FURTHER INFORMATION CONTACT: Director, Office of Financial
Services, Office of Administration, 370 L'Enfant Promenade, SW.,
Washington, DC 20047. Telephone Number (202) 401-7237.
SUPPLEMENTARY INFORMATION: Pub. L. 100-503, the Computer Matching and
Privacy Protection Act of 1988, amended the Privacy Act (5 U.S.C. 552a)
by adding certain protections for individuals applying for and
receiving federal benefits. The law regulates the use of computer
matching by federal agencies when records in a system of records are
matched with other federal, state and local government records.
Federal agencies which provide or receive records in computer
matching programs must:
1. Negotiate written agreements with source agencies;
2. Provide notification to applicants and beneficiaries that their
records are subject to matching;
3. Verify match findings before reducing, suspending, or
terminating an individual's benefits or payments;
4. Furnish detailed reports to Congress and OMB; and,
5. Establish a Data Integrity Board that must approve matching
agreements.
This computer matching program meets the requirements of Pub. L.
100-503.
Dated: June 21, 2006.
Curtis L. Coy,
Deputy Assistant Secretary for Administration, ACF.
Notice of Computer Matching Program
A. Participating Agencies
VA and the SPAAs.
B. Purpose of the Match
To identify specific individuals who are receiving benefits from VA
and also
[[Page 40129]]
receiving payments pursuant to HHS and Department of Agriculture
benefit programs, and to verify their continued eligibility for such
benefits. SPAAs will contact affected individuals and seek to verify
the information resulting from the match before initiating any adverse
actions based on the match results.
C. Authority for Conducting the Match
The authority for conducting the matching program is contained in
section 402(a)(6) of the Social Security Act [42 U.S.C. 602(a)(6)].
D. Records To Be Matched
VA will disclose records from its Privacy Act system of records
entitled ``Compensation, Pension, Education and Rehabilitation
Records.'' (58 VA 21/22 first published at 41 FR 9294 (March 3, 1976),
and last amended at 70 FR 34186 (June 13, 2005)). VA's disclosure of
information for use in this computer match is listed as a routine use
in this system of records.
VA, as the source agency, will prepare electronic files containing
the names and other personal identifying data of eligible veterans
receiving benefits. These records are matched electronically against
SPAA files consisting of data regarding monthly Medicaid, Temporary
Assistance to Needy Families (TANF), general assistance, and Food Stamp
beneficiaries.
1. The electronic files provided by the SPAAs will contain client
names and Social Security numbers (SSNs.)
2. The resulting output returned to the SPAAs will contain personal
identifiers, including names, SSNs, employers, current work or home
addresses, etc.
E. Inclusive Dates of the Matching Program
The effective date of the matching agreement and date when matching
may actually begin shall be at the expiration of the 40-day review
period for OMB and Congress, or 30 days after publication of the
matching notice in the Federal Register, whichever date is later. The
matching program will be in effect for 18 months from the effective
date, with an option to renew for 12 additional months, unless one of
the parties to the agreement advises the others by written request to
terminate or modify the agreement.
[FR Doc. 06-6226 Filed 7-13-06; 8:45 am]
BILLING CODE 4184-01-M
