Drugs for Human Use; Drug Efficacy Study Implementation; Parenteral Multivitamin Drug Products; Announcement of Unlawful Formulations, 19762-19763 [05-7532]
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19762
Federal Register / Vol. 70, No. 71 / Thursday, April 14, 2005 / Notices
Place: Agency for Healthcare Research
& Quality, 540 Gaither Road, Conference
Center, Rockville, Maryland 20850.
Contact Person: Anyone wishing to
obtain information regarding this
meeting should contact Thomas Boyce,
Office of Performance Accountability,
Resources and Technology, Agency for
Healthcare Research and Quality, 540
Gaither Road, Rockville, Maryland
20850, (301) 427–1796.
Dated: April 4, 2005.
Carolyn M. Clancy,
Director.
[FR Doc. 05–7474 Filed 4–13–05; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Compassion Capital Fund
Evaluation.
OMB No.: New Collection.
Description: This proposed
information collection activity is for two
rounds of surveys to be completed by
faith-based and community
organizations participating in the
Compassion Capital Fund (CCF)
evaluation project. The first survey will
be conducted as a baseline survey and
the second will be a follow-up survey
conducted several months later.
The CCF evaluation is an important
opportunity to examine the
effectiveness of the Compassion Capital
Fund in meeting its objective of
improving the capacity of faith-based
and community organizations. The
evaluation will involve up to 1,000
faith-based and community
organizations that seek services from
CCF-funded intermediary organizations.
Information will be collected from these
faith-based and community-based
organizations to assess change and
improvement in various areas of
capacity. The study design includes the
random assignment of faith-based and
community organizations to either a
treatment group that receives capacitybuilding services from a CCF
intermediary grantee or to a control
group that does not. The impact of the
Number of
respondents
Instrument
services provided by intermediaries,
primarily through sub-awards and/or
technical assistance (TA), will be
determined by comparing the changes
in organizational and service capacity of
the recipient organizations with those of
the control group.
Respondents: The respondents for
both the baseline and follow-up data
collection will be faith-based and
community organizations that seek subawards or TA from selected CCF
intermediary grantees. The baseline
survey will be primarily selfadministered and is expected to be
completed as part of the intermediary’s
sub-award application or TA request
process. The follow-up survey also will
be primarily self-administered and
contain questions similar to those in the
baseline survey as well as additional
questions related to services received
from the intermediary or other
organizations. It is expected that the
follow-up survey will be administered
approximately 9–12 months after
random assignment. As needed to
increase response rates, the survey will
be administered by telephone to
organizations that do not initially return
a completed survey.
Number of responses per respondent
Average burden hours per response
Total
burden
hours
Baseline Survey ....................................................
Follow-up Survey ..................................................
1,000
1,000
............................
............................
1.33 hours (20 minutes) .......................................
1.42 hours (25 minutes) .......................................
330
420
Estimated Total Annual Burden Hours ..........
....................
............................
..........................................................................
750
Annual Burden Estimates
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:
grjohnson@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
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19:36 Apr 13, 2005
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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. Consideration will be
given to comments and suggestions
submitted within 60 days of this
publication.
Dated: April 11, 2005.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 05–7517 Filed 4–13–05; 8:45 am]
BILLING CODE 4184–01–M
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 1979N–0113 (formerly Docket
No. 79N–0113); DESI 2847]
Drugs for Human Use; Drug Efficacy
Study Implementation; Parenteral
Multivitamin Drug Products;
Announcement of Unlawful
Formulations
Food and Drug Administration.
Notice.
AGENCY:
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is declaring
unlawful the unapproved marketing of
certain parenteral multivitamin drug
products for which a hearing was
requested, but for which the sponsors
have withdrawn the hearing requests.
FDA is taking this action because the
products lack substantial evidence of
effectiveness as fixed combination drug
products.
E:\FR\FM\14APN1.SGM
14APN1
Federal Register / Vol. 70, No. 71 / Thursday, April 14, 2005 / Notices
DATES:
This notice is effective May 16,
2005.
Requests for an opinion of
the applicability of this notice to a
specific product should be identified
with Docket No. 1979N–0113 and
reference number DESI 2847 and
directed to the Division of New Drugs
and Labeling Compliance (HFD–310),
Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT:
Mary Catchings, Center for Drug
Research and Evaluation (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2041.
ADDRESSES:
In a notice
published in the Federal Register of
September 17, 1984 (49 FR 36446) (the
September 1984 notice), FDA
announced the conditions for marketing
an effective parenteral multivitamin
drug product. The effective 12-vitamin
formulation set forth in the notice was
based on the clinical evaluation of a
guideline formulation recommended by
the American Medical Association. (In
the Federal Register of April 20, 2000
(65 FR 21200), FDA amended the
September 1984 notice by increasing the
dosage of certain vitamins and by
adding vitamin K to the formulation.)
The September 1984 notice, published
as part of the Drug Efficacy Study
Implementation, also revoked the
temporary exemption (paragraph XIV,
category XI) for three original
formulation products that had been
allowed to remain on the market while
guideline formulations were studied.
The notice stated that FDA was unaware
of any adequate and well-controlled
clinical trials meeting the requirements
of section 505(e) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 355(e)), 21 CFR 300.50, and 21
CFR 314.111(a)(5) (now 21 CFR
314.125(b)(5)) and demonstrating the
effectiveness of these products;
therefore, FDA proposed to withdraw
approval of the portions of the new drug
applications (NDAs) pertaining to the
original formulations. The notice offered
affected parties an opportunity for a
hearing on the proposal.
In response to the September 1984
notice, Hoffmann-LaRoche, Inc., USV
Pharmaceutical Corp., LyphoMed, Inc.
(subsequently acquired by American
Pharmaceutical Partners, Inc.), and
Carter-Glogau Laboratories, Inc.
(subsequently acquired by Schein
Pharmaceutical, Inc.), submitted hearing
requests. Hoffmann-LaRoche and USV
voluntarily withdrew their hearing
SUPPLEMENTARY INFORMATION:
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19:36 Apr 13, 2005
Jkt 205001
requests shortly after they were
submitted; therefore, FDA withdrew
approval of the NDAs for the HoffmannLaRoche and USV products in Federal
Register notices of February 28, 1985
(50 FR 8193), and December 27, 1985
(50 FR 53014). The following hearing
requests were still pending:
1. MultiVitamin Concentrate; No
NDA; American Pharmaceutical
Partners, Inc. (APP), 2045 North Cornell
Ave., Melrose Park, IL 60160–1002.
Each 5-milliliter vial of MultiVitamin
Concentrate contained ascorbic acid
(vitamin C) 500 milligrams (mg),
vitamin A (retinol) 3 mg (10,000
International Units (I.U.)), vitamin D
(ergocalciferol) 25 micrograms (1,000
I.U.), thiamine (B1) 50 mg, riboflavin
(B2) 10 mg, pyridoxine (B6) 15 mg,
niacin (B3) 100 mg, pantothenic acid 25
mg, and vitamin E 3 mg (5 I.U.).
2. The hearing request, which named
no specific product, referenced products
named in the September 1984 notice;
No NDA; Schein Pharmaceutical, Inc.
(Schein), 100 Campus Dr., Florham
Park, NJ 07932.
In letters dated May 27, 1999, and
April 8, 2003, Schein and APP,
respectively, withdrew the hearing
requests previously submitted regarding
parenteral multivitamin products. The
letter from APP noted that it had
discontinued marketing MultiVitamin
Concentrate. Accordingly, there are no
pending hearing requests submitted in
response to the September 1984 notice
of opportunity for hearing. No
parenteral multivitamin product
remains exempt under the paragraph
XIV, category XI exemption.
This notice applies to any drug
product that is identical, related, or
similar to the products specified and
referenced previously in this document
and is not the subject of an approved
NDA (21 CFR 310.6). Any person who
wishes to determine whether a specific
product is covered by this notice should
write to the Division of New Drugs and
Labeling Compliance (see ADDRESSES).
Based on the information presented in
the September 1984 and April 20, 2000,
Federal Register notices, the Acting
Director of the Center for Drug
Evaluation and Research, under the act
(section 505(e)) and under authority
delegated to him (21 CFR 5.100), finds
that, on the basis of new information on
these drugs, evaluated with the
evidence available previously, there is a
lack of substantial evidence that the
products named and referenced
previously will have the effects they are
purported or represented to have under
the conditions of use prescribed,
recommended, or suggested in their
labeling.
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19763
Therefore, based on the foregoing
finding, MultiVitamin Concentrate and
the original formulation parenteral
multivitamin product(s), for which
Schein requested a hearing, are declared
unlawful, effective May 16, 2005.
Shipment in interstate commerce of
these drug products or any identical,
related, or similar product that is not the
subject of an approved NDA will then
be unlawful.
Dated: April 5, 2005.
Steven Galson,
Acting Director, Center for Drug Evaluation
and Research.
[FR Doc. 05–7532 Filed 4–13–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Drug Safety and Risk Management
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Drug Safety and
Risk Management Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will held
on May 18 and 19, 2005, from 8:30 a.m.
to 5 p.m.
Location: Holiday Inn, The Ballrooms,
8777 Georgia Ave., Silver Spring, MD.
Contact Person: Shalini Jain, Center
for Drug Evaluation and Research (HFD–
21), Food and Drug Administration,
5600 Fishers Lane (for express delivery,
5630 Fishers Lane, rm. 1093), Rockville,
MD 20857, 301–827–7001, e-mail:
jains@cder.fda.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512535. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: This is the first in a series of
meetings related to the issues in drug
safety and FDA. This 2-day meeting will
explore issues related to FDA’s risk
assessment program for marketed drugs.
There are a number of methods that
FDA uses in risk assessment of
marketed drugs, including review and
analysis of spontaneous reports of
E:\FR\FM\14APN1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 71 (Thursday, April 14, 2005)]
[Notices]
[Pages 19762-19763]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7532]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 1979N-0113 (formerly Docket No. 79N-0113); DESI 2847]
Drugs for Human Use; Drug Efficacy Study Implementation;
Parenteral Multivitamin Drug Products; Announcement of Unlawful
Formulations
AGENCY: Food and Drug Administration.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is declaring unlawful
the unapproved marketing of certain parenteral multivitamin drug
products for which a hearing was requested, but for which the sponsors
have withdrawn the hearing requests. FDA is taking this action because
the products lack substantial evidence of effectiveness as fixed
combination drug products.
[[Page 19763]]
DATES: This notice is effective May 16, 2005.
ADDRESSES: Requests for an opinion of the applicability of this notice
to a specific product should be identified with Docket No. 1979N-0113
and reference number DESI 2847 and directed to the Division of New
Drugs and Labeling Compliance (HFD-310), Center for Drug Evaluation and
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: Mary Catchings, Center for Drug
Research and Evaluation (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of September 17, 1984 (49 FR 36446) (the September 1984
notice), FDA announced the conditions for marketing an effective
parenteral multivitamin drug product. The effective 12-vitamin
formulation set forth in the notice was based on the clinical
evaluation of a guideline formulation recommended by the American
Medical Association. (In the Federal Register of April 20, 2000 (65 FR
21200), FDA amended the September 1984 notice by increasing the dosage
of certain vitamins and by adding vitamin K to the formulation.) The
September 1984 notice, published as part of the Drug Efficacy Study
Implementation, also revoked the temporary exemption (paragraph XIV,
category XI) for three original formulation products that had been
allowed to remain on the market while guideline formulations were
studied. The notice stated that FDA was unaware of any adequate and
well-controlled clinical trials meeting the requirements of section
505(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
355(e)), 21 CFR 300.50, and 21 CFR 314.111(a)(5) (now 21 CFR
314.125(b)(5)) and demonstrating the effectiveness of these products;
therefore, FDA proposed to withdraw approval of the portions of the new
drug applications (NDAs) pertaining to the original formulations. The
notice offered affected parties an opportunity for a hearing on the
proposal.
In response to the September 1984 notice, Hoffmann-LaRoche, Inc.,
USV Pharmaceutical Corp., LyphoMed, Inc. (subsequently acquired by
American Pharmaceutical Partners, Inc.), and Carter-Glogau
Laboratories, Inc. (subsequently acquired by Schein Pharmaceutical,
Inc.), submitted hearing requests. Hoffmann-LaRoche and USV voluntarily
withdrew their hearing requests shortly after they were submitted;
therefore, FDA withdrew approval of the NDAs for the Hoffmann-LaRoche
and USV products in Federal Register notices of February 28, 1985 (50
FR 8193), and December 27, 1985 (50 FR 53014). The following hearing
requests were still pending:
1. MultiVitamin Concentrate; No NDA; American Pharmaceutical
Partners, Inc. (APP), 2045 North Cornell Ave., Melrose Park, IL 60160-
1002. Each 5-milliliter vial of MultiVitamin Concentrate contained
ascorbic acid (vitamin C) 500 milligrams (mg), vitamin A (retinol) 3 mg
(10,000 International Units (I.U.)), vitamin D (ergocalciferol) 25
micrograms (1,000 I.U.), thiamine (B1) 50 mg, riboflavin (B2) 10 mg,
pyridoxine (B6) 15 mg, niacin (B3) 100 mg, pantothenic acid 25 mg, and
vitamin E 3 mg (5 I.U.).
2. The hearing request, which named no specific product, referenced
products named in the September 1984 notice; No NDA; Schein
Pharmaceutical, Inc. (Schein), 100 Campus Dr., Florham Park, NJ 07932.
In letters dated May 27, 1999, and April 8, 2003, Schein and APP,
respectively, withdrew the hearing requests previously submitted
regarding parenteral multivitamin products. The letter from APP noted
that it had discontinued marketing MultiVitamin Concentrate.
Accordingly, there are no pending hearing requests submitted in
response to the September 1984 notice of opportunity for hearing. No
parenteral multivitamin product remains exempt under the paragraph XIV,
category XI exemption.
This notice applies to any drug product that is identical, related,
or similar to the products specified and referenced previously in this
document and is not the subject of an approved NDA (21 CFR 310.6). Any
person who wishes to determine whether a specific product is covered by
this notice should write to the Division of New Drugs and Labeling
Compliance (see ADDRESSES).
Based on the information presented in the September 1984 and April
20, 2000, Federal Register notices, the Acting Director of the Center
for Drug Evaluation and Research, under the act (section 505(e)) and
under authority delegated to him (21 CFR 5.100), finds that, on the
basis of new information on these drugs, evaluated with the evidence
available previously, there is a lack of substantial evidence that the
products named and referenced previously will have the effects they are
purported or represented to have under the conditions of use
prescribed, recommended, or suggested in their labeling.
Therefore, based on the foregoing finding, MultiVitamin Concentrate
and the original formulation parenteral multivitamin product(s), for
which Schein requested a hearing, are declared unlawful, effective May
16, 2005.
Shipment in interstate commerce of these drug products or any
identical, related, or similar product that is not the subject of an
approved NDA will then be unlawful.
Dated: April 5, 2005.
Steven Galson,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 05-7532 Filed 4-13-05; 8:45 am]
BILLING CODE 4160-01-S
