Draft Guidance for Industry on Orally Disintegrating Tablets; Availability, 17563-17564 [E7-6509]
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Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Notices
Submit written requests for
single copies of the draft guidance to the
Office of Critical Path Programs (HF–
18), Office of the Commissioner, Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. Send one
self-addressed adhesive label to assist
that office in processing your requests.
Submit telephone requests to 800–835–
4709 or 301–827–1800. Submit written
comments on the draft guidance to the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access to the draft guidance document.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:
Terrie L. Crescenzi, Office of Critical
Path Programs (HF–18), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–7864.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
sroberts on PROD1PC70 with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance for clinical
investigators, sponsors, and IRBs
entitled ‘‘Guidance for Clinical
Investigators, Sponsors, and IRBs;
Adverse Event Reporting—Improving
Human Subject Protection.’’ Under the
regulations in 21 CFR part 50
(Protection of Human Subjects), part 56
(21 CFR part 56) (Institutional Review
Boards), part 312 (21 CFR part 312)
(Investigational New Drug Application),
and part 812 (21 CFR part 812)
(Investigational Device Exemptions), an
IRB must review and approve a clinical
study before the study is initiated.
Additionally, after an IRB’s initial
review and approval, an IRB must
conduct continuing review of the study
at intervals appropriate to the degree of
risk presented by the study, at least
annually. The primary purpose of both
the initial review of a study and the
periodic review of the conduct of the
study is to assure the protection of the
rights and welfare of human subjects. To
assure the protection of the rights and
welfare of human subjects during the
conduct of a clinical study, an IRB must
have information concerning
unanticipated problems in the study
and changes in the research activity.
Such information may be important to
the IRB’s review. This draft guidance
discusses adverse event reporting to
IRBs by sponsors, and investigators, and
emphasizes the greater value of wellanalyzed adverse event data to an IRBs
review. This draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
VerDate Aug<31>2005
18:21 Apr 06, 2007
Jkt 211001
10.115). The draft guidance, when
finalized, will represent the agency’s
current thinking on adverse event
reporting for the purpose of improving
human subject protection. 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 statutes and regulations.
II. The Paperwork Reduction Act of
1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in part 56 have been
approved under OMB Control No. 0910–
0130; the collections of information in
part 312 have been approved under
OMB Control No. 0910–0014; and the
collections of information in part 812
have been approved under OMB Control
No. 0910–0078.
III. Comments
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.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm or https://www.fda.gov/
ohrms/dockets/default.htm.
Dated: April 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–6595 Filed 4–6–07; 8:45 am]
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17563
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D–0117]
Draft Guidance for Industry on Orally
Disintegrating Tablets; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Orally Disintegrating
Tablets.’’ The draft guidance provides
pharmaceutical manufacturers of new
and generic drug products with an
agency perspective on the definition of
an orally disintegrating tablet (ODT) and
also provides recommendations to
applicants who would like to designate
a proposed product as an ODT.
DATES: Submit written or electronic
comments on the draft guidance by June
8, 2007. General comments on agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the draft 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 draft
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:
Frank O. Holcombe, Jr., Center for Drug
Evaluation and Research (HFD–600),
Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240–
276–9310.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Orally Disintegrating Tablets.’’ The
draft guidance provides pharmaceutical
manufacturers of new and generic drug
products with an agency perspective on
the definition of an ODT and also
provides recommendations to
applicants who would like to designate
proposed products as ODTs.
E:\FR\FM\09APN1.SGM
09APN1
17564
Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Notices
In an effort to develop drug products
that are more convenient to use and to
address potential issues of patient
compliance for certain product
indications and patient populations,
pharmaceutical manufacturers have
developed products that can be ingested
simply by placing them on the tongue.
The products are designed to
disintegrate or dissolve rapidly on
contact with saliva, thus eliminating the
need for chewing the tablet, swallowing
an intact tablet, or taking the tablet with
water. This mode of administration was
initially expected to be beneficial to
pediatric and geriatric patients, to
people with conditions related to
impaired swallowing, and for treatment
of patients when compliance may be
difficult (e.g., for psychiatric disorders).
As firms started developing additional
products using different technology and
formulations, many of these later
products exhibited wide variation in
product characteristics from the initial
products. Because this shift in product
characteristics can affect a product’s
suitability for particular uses, the
agency developed this guidance for
industry.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on orally disintegrating tablets. 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 statutes and regulations.
II. Comments
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.
sroberts on PROD1PC70 with NOTICES
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm or https://www.fda.gov/
ohrms/dockets/default.htm.
VerDate Aug<31>2005
18:21 Apr 06, 2007
Jkt 211001
Dated: March 30, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–6509 Filed 4–6–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Council on Graduate Medical
Education; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Council on Graduate Medical
Education (COGME).
Dates and Times: April 30, 2007, 8:30
a.m.– 5 p.m.; and May 1, 2007, 8:30 a.m.–
2:30 p.m.
Place: Hilton Washington, DC/Rockville
Executive Meeting Center, 1750 Rockville
Pike, Rockville, Maryland 20852–1699.
Status: The meeting will be open to the
public.
Agenda: The agenda for April 30 in the
morning will include: Welcome and opening
comments from the Chair and Executive
Secretary of COGME and senior management
staff of the Health Resources and Services
Administration.
On April 30, following the welcoming
remarks from the COGME Chair, the
Executive Secretary of COGME, and Agency
senior management, there will be a review
and discussion of the draft paper ‘‘Enhancing
GME Flexibility,’’ by Barbara Chang, M.D.,
and other writing group members. After
lunch there will be a review and discussion
of the draft paper ‘‘New Paradigms for
Physician Training for Improving Access to
Healthcare’’ by Earl Reisdorff, M.D. and other
writing group members. At 3 p.m. there will
be a breakout of Council members into the
two draft writing groups for further report
revisions.
On May 1 there will be reports to the
Council and further discussion on writing
group activities and reports. The Council will
conclude with a discussion of the timeframe
and next steps for producing the Reports.
Agenda items are subject to change as
priorities dictate.
FOR FURTHER INFORMATION CONTACT:
Jerald M. Katzoff, Executive Secretary,
COGME, Division of Medicine and
Dentistry, Bureau of Health Professions,
Parklawn Building, Room 9A–27, 5600
Fishers Lane, Rockville, Maryland
20857, Telephone (301) 443–6785.
Dated: April 2, 2007.
Caroline Lewis,
Acting Associate Administrator for
Administration and Financial Management.
[FR Doc. E7–6597 Filed 4–6–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Reimbursement of Travel and
Subsistence Expenses Toward Living
Organ Donation Proposed Eligibility
Guidelines
Health Resources and Services
Administration (HRSA), HHS.
ACTION: Request for Public Comment.
AGENCY:
SUMMARY: HRSA is soliciting comments
on the proposed eligibility criteria for
the Reimbursement of Travel and
Subsistence Expenses toward Living
Organ Donations Program. Eligibility
criteria were proposed by the program
grantee, the Regents of the University of
Michigan, to HRSA. HRSA has
determined that the proposed eligibility
criteria constitute a proper
interpretation of the authorizing
statute’s requirements, including
determinations as to which individuals
would otherwise be unable to meet the
eligible expenses authorized under this
Program. HRSA is soliciting public
comment on the criteria outlined in this
notice. HRSA will consider the
comments in light of the authorizing
statute and seek feedback from the
Regents of the University of Michigan
concerning the comments. HRSA will
then approve final criteria. The final
program eligibility criteria will be
posted on the Reimbursement of Travel
and Subsistence Expenses for Living
Organ Donation Web site, https://
www.livingdonorassistance.org.
Written comments must be
submitted to the office in the address
section below by mail or e-mail on or
before May 24, 2007.
ADDRESSES: Please send all written
comments to James F. Burdick, M.D.,
Director, Division of Transplantation,
Healthcare Systems Bureau, Health
Resources and Services Administration,
Room 12C–06, Parklawn Building, 5600
Fishers Lane, Rockville, Maryland
20857; telephone (301) 443–7577; fax
(301) 594–6095; or e-mail:
jburdick@hrsa.gov.
DATES:
FOR FURTHER INFORMATION CONTACT:
James F. Burdick, M.D., Director,
Division of Transplantation, Healthcare
Systems Bureau, Health Resources and
Services Administration, Parklawn
Building, Room 12C–06, 5600 Fishers
Lane, Rockville, Maryland 20857;
telephone (301) 443–7577; fax (301)
594–6095; or e-mail: jburdick@hrsa.gov.
SUPPLEMENTARY INFORMATION: Congress
has provided specific authority under
E:\FR\FM\09APN1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 67 (Monday, April 9, 2007)]
[Notices]
[Pages 17563-17564]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-6509]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0117]
Draft Guidance for Industry on Orally Disintegrating Tablets;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Orally
Disintegrating Tablets.'' The draft guidance provides pharmaceutical
manufacturers of new and generic drug products with an agency
perspective on the definition of an orally disintegrating tablet (ODT)
and also provides recommendations to applicants who would like to
designate a proposed product as an ODT.
DATES: Submit written or electronic comments on the draft guidance by
June 8, 2007. General comments on agency guidance documents are welcome
at any time.
ADDRESSES: Submit written requests for single copies of the draft
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 self-addressed adhesive label to
assist that office in processing your requests. Submit written comments
on the draft 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: Frank O. Holcombe, Jr., Center for
Drug Evaluation and Research (HFD-600), Food and Drug Administration,
7500 Standish Pl., Rockville, MD 20855, 240-276-9310.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Orally Disintegrating Tablets.'' The draft guidance provides
pharmaceutical manufacturers of new and generic drug products with an
agency perspective on the definition of an ODT and also provides
recommendations to applicants who would like to designate proposed
products as ODTs.
[[Page 17564]]
In an effort to develop drug products that are more convenient to
use and to address potential issues of patient compliance for certain
product indications and patient populations, pharmaceutical
manufacturers have developed products that can be ingested simply by
placing them on the tongue. The products are designed to disintegrate
or dissolve rapidly on contact with saliva, thus eliminating the need
for chewing the tablet, swallowing an intact tablet, or taking the
tablet with water. This mode of administration was initially expected
to be beneficial to pediatric and geriatric patients, to people with
conditions related to impaired swallowing, and for treatment of
patients when compliance may be difficult (e.g., for psychiatric
disorders).
As firms started developing additional products using different
technology and formulations, many of these later products exhibited
wide variation in product characteristics from the initial products.
Because this shift in product characteristics can affect a product's
suitability for particular uses, the agency developed this guidance for
industry.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on orally
disintegrating tablets. 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 statutes and regulations.
II. Comments
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.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/cder/guidance/index.htm or https://
www.fda.gov/ohrms/dockets/default.htm.
Dated: March 30, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-6509 Filed 4-6-07; 8:45 am]
BILLING CODE 4160-01-S?>
