Request for Comment on the Status of Pyridoxamine, 69976-69977 [05-22884]
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Federal Register / Vol. 70, No. 222 / Friday, November 18, 2005 / Notices
business application owners to use the
form flow process of the user
provisioning service to approve or deny
requests for access to business
applications. The primary purpose of
this system is to implement a unified
framework for managing user
information and access rights, for those
individuals who apply for and are
granted access across multiple CMS
systems and business contexts.
Information in this system will also be
used to: (1) Support regulatory and
policy functions performed within the
Agency or by a contractor or consultant;
(2) support constituent requests made to
a Congressional representative; and (3)
to support litigation involving the
Agency related to this system. We have
provided background information about
the proposed system in the
‘‘Supplementary Information’’ section
below. Although the Privacy Act
requires only that the ‘‘routine use’’
portion of the system be published for
comment, CMS invites comments on all
portions of this notice. See ‘‘Effective
Dates’’ section for comment period;
Frequency: Other—As required;
Affected Public: Business or other-forprofit, Individuals or Households, Notfor-profit institutions, Federal
government, and State, Local, or Tribal
Government; Number of Respondents:
60,000,000; Total Annual Responses:
60,000,000; Total Annual Hours:
15,000,000.
2. Type of Information Collection
Request: New Collection; Title of
Information Collection: Rehabilitation
Unit Criteria Work Sheet and
Rehabilitation Hospital Criteria Work
Sheet and Supporting Regulations at 42
CFR 488.26; Form Number: CMS–437A
and CMS–437B (OMB#: 0938–NEW—
NOTE: These instruments are currently
approved under 0938–0358 but are
being carved out into a separate
collection as they are updated more
frequently.); Use: The rehabilitation
hospital and rehabilitation unit criteria
work sheets are necessary to verify that
these facilities/units comply and remain
in compliance with the exclusion
criteria for the Medicare prospective
payment system; Frequency: Annually;
Affected Public: Business or other-forprofit, Not-for-profit institutions, and
State, Local, or Tribal Government;
Number of Respondents: 1227; Total
Annual Responses: 1227; Total Annual
Hours: 306.75.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web Site
address at https://www.cms.hhs.gov/
regulations/pra/, or E-mail your request,
including your address, phone number,
VerDate Aug<31>2005
15:21 Nov 17, 2005
Jkt 208001
OMB number, and CMS document
identifier, to Paperwork@cms.hhs.gov,
or call the Reports Clearance Office on
(410) 786–1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received at the address below, no
later than 5 p.m. on January 17, 2006.
CMS, Office of Strategic Operations and
Regulatory Affairs, Division of
Regulations Development, Attention:
William N. Parham, III, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: November 9, 2005.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 05–22906 Filed 11–17–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005P–0305]
Request for Comment on the Status of
Pyridoxamine
AGENCY:
Food and Drug Administration,
HHS.
Notice of opportunity to
comment.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that comments related to the status of
pyridoxamine may be submitted until
December 19, 2005. FDA is requesting
comments in response to the submission
of a citizen petition requesting, among
other things, that the agency determine
the status of pyridoxamine. All
comments postmarked on or before
December 19, 2005 will be accepted as
part of the official record for this matter.
DATES: Submit written comments by
December 19, 2005.
ADDRESSES: Submit written comments
on the status of pyridoxamine 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.
FOR FURTHER INFORMATION CONTACT:
Robert Moore, Center for Food Safety
and Applied Nutrition (HFS–810), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
301–436–1441.
SUPPLEMENTARY INFORMATION: On July
29, 2005, FDA received a citizen
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
petition submitted, under 21 CFR 10.30,
by the law firm Morgan Lewis &
Bockius, LLP, on behalf of BioStratum,
Inc. The petition requests that the
agency: (1) State in writing that dietary
supplements that contain pyridoxamine
are adulterated under the Federal Food,
Drug, and Cosmetic Act; (2) exercise its
enforcement authority under the act to
remove from interstate commerce
dietary supplements containing
pyridoxamine; and (3) not place this
citizen petition in the agency’s docket
for premarket notifications for new
dietary ingredients (Docket No. 2004N–
0454).
In its citizen petition, BioStratum,
Inc., states, among other things, that it
is the manufacturer of Pyridorin
(pyridoxamine dihydrochloride), which
is the subject of an investigational new
drug application (IND) that was filed
with FDA in July 1999 for use as a
potential therapeutic agent to slow or
prevent the progression of diabetic
nephropathy in patients with type 1 and
type 2 diabetes. The petition further
states that substantial clinical trials have
been conducted for this drug and that
the existence of those studies has been
made public. In addition, the petition
states that pyridoxamine was not
marketed as a dietary supplement or as
a food prior to Pyridorin’s authorization
for investigation as a new drug under an
IND.
FDA has considered the information
and legal argument set forth in the
petition. Based on the facts set forth in
the petition, the agency tentatively
concludes that pyridoxamine, the active
moiety1 of pyridoxamine
dihydrochloride, is excluded from the
dietary supplement definition under the
exclusion clause in 21 U.S.C.
321(ff)(3)(B)(ii) and therefore may not be
marketed as or in a dietary supplement.
However, although the petition asserts
that there is no evidence that
pyridoxamine was marketed as a dietary
ingredient or as a food prior to the
authorization of Pyridorin for
investigation under an IND, the agency
is interested in receiving information, if
any, that bears on pyridoxamine’s prior
marketing as a dietary ingredient or as
a food, as well as other information that
would inform the agency’s final
decision on the status of pyridoxamine.
1 Under 21 CFR 316.3(b)(2), ‘‘active moiety’’
means the molecule or ion, excluding those
appended portions of the molecule that cause the
drug to be an ester, salt (including a salt with
hydrogen or coordination bonds), or other
noncovalent derivative (such as a complex, chelate,
or clathrate) of the molecule, responsible for the
physiological or pharmacological action of the drug
substance.
E:\FR\FM\18NON1.SGM
18NON1
Federal Register / Vol. 70, No. 222 / Friday, November 18, 2005 / Notices
In order to afford all interested parties
adequate opportunity to participate in
this matter, the agency requests
comments and supporting information
related to this matter. 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 office above between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: November 10, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–22884 Filed 11–17–05; 8:45 am]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
15:21 Nov 17, 2005
Jkt 208001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FDA 225–05–8004]
Implementation Plan on the Sharing of
Confidential Information Between the
European Commission’s Health and
Consumer Protection Directorate
General and the United States Food
and Drug Administration of the
Department of Health and Human
Services
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is providing
notice of an Implementation Plan on the
sharing of confidential information
between the European Commission’s
Health and Consumer Protection
Directorate General and the United
States Food and Drug Administration of
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
69977
the Department of Health and Human
Services. The purpose is for both
participants to cooperate to facilitate the
sharing of documents and/or
information related to food safety.
DATES: The agreement became effective
on September 23, 2005.
FOR FURTHER INFORMATION CONTACT:
Matthew E. Eckel, Office of
International Programs (HFG–1), Food
and Drug Administration, 5600 Fishers
Lane, Rockville MD, 20857, 301–827–
4480; FAX 301–480–0716.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 20.108(c),
which states that all written agreements
and Implementation Plans between FDA
and others shall be published in the
Federal Register, the agency is
publishing notice of this
Implementation Plan.
Dated: November 10, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
BILLING CODE 4160–01–S
E:\FR\FM\18NON1.SGM
18NON1
]]>Agencies
[Federal Register Volume 70, Number 222 (Friday, November 18, 2005)]
[Notices]
[Pages 69976-69977]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-22884]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005P-0305]
Request for Comment on the Status of Pyridoxamine
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of opportunity to comment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that
comments related to the status of pyridoxamine may be submitted until
December 19, 2005. FDA is requesting comments in response to the
submission of a citizen petition requesting, among other things, that
the agency determine the status of pyridoxamine. All comments
postmarked on or before December 19, 2005 will be accepted as part of
the official record for this matter.
DATES: Submit written comments by December 19, 2005.
ADDRESSES: Submit written comments on the status of pyridoxamine 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.
FOR FURTHER INFORMATION CONTACT: Robert Moore, Center for Food Safety
and Applied Nutrition (HFS-810), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 301-436-1441.
SUPPLEMENTARY INFORMATION: On July 29, 2005, FDA received a citizen
petition submitted, under 21 CFR 10.30, by the law firm Morgan Lewis &
Bockius, LLP, on behalf of BioStratum, Inc. The petition requests that
the agency: (1) State in writing that dietary supplements that contain
pyridoxamine are adulterated under the Federal Food, Drug, and Cosmetic
Act; (2) exercise its enforcement authority under the act to remove
from interstate commerce dietary supplements containing pyridoxamine;
and (3) not place this citizen petition in the agency's docket for
premarket notifications for new dietary ingredients (Docket No. 2004N-
0454).
In its citizen petition, BioStratum, Inc., states, among other
things, that it is the manufacturer of Pyridorin (pyridoxamine
dihydrochloride), which is the subject of an investigational new drug
application (IND) that was filed with FDA in July 1999 for use as a
potential therapeutic agent to slow or prevent the progression of
diabetic nephropathy in patients with type 1 and type 2 diabetes. The
petition further states that substantial clinical trials have been
conducted for this drug and that the existence of those studies has
been made public. In addition, the petition states that pyridoxamine
was not marketed as a dietary supplement or as a food prior to
Pyridorin's authorization for investigation as a new drug under an IND.
FDA has considered the information and legal argument set forth in
the petition. Based on the facts set forth in the petition, the agency
tentatively concludes that pyridoxamine, the active moiety\1\ of
pyridoxamine dihydrochloride, is excluded from the dietary supplement
definition under the exclusion clause in 21 U.S.C. 321(ff)(3)(B)(ii)
and therefore may not be marketed as or in a dietary supplement.
However, although the petition asserts that there is no evidence that
pyridoxamine was marketed as a dietary ingredient or as a food prior to
the authorization of Pyridorin for investigation under an IND, the
agency is interested in receiving information, if any, that bears on
pyridoxamine's prior marketing as a dietary ingredient or as a food, as
well as other information that would inform the agency's final decision
on the status of pyridoxamine.
---------------------------------------------------------------------------
\1\ Under 21 CFR 316.3(b)(2), ``active moiety'' means the
molecule or ion, excluding those appended portions of the molecule
that cause the drug to be an ester, salt (including a salt with
hydrogen or coordination bonds), or other noncovalent derivative
(such as a complex, chelate, or clathrate) of the molecule,
responsible for the physiological or pharmacological action of the
drug substance.
---------------------------------------------------------------------------
[[Page 69977]]
In order to afford all interested parties adequate opportunity to
participate in this matter, the agency requests comments and supporting
information related to this matter. 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 office above
---------------------------------------------------------------------------
between 9 a.m. and 4 p.m., Monday through Friday.
Dated: November 10, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-22884 Filed 11-17-05; 8:45 am]
BILLING CODE 4160-01-S
