Draft Guidance for Industry and Food and Drug Administration Staff; “‘Harmful and Potentially Harmful Constituents’ in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act”; Availability, 32952-32953 [2010-14046]
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32952
Federal Register / Vol. 75, No. 111 / Thursday, June 10, 2010 / Notices
PROMACTA and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of Patents and Trademarks,
Department of Commerce, for the
extension of a patent which claims that
human drug product.
ADDRESSES: Submit written comments
and petitions 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.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of Patents and Trademarks may
award (for example, half the testing
phase must be subtracted as well as any
time that may have occurred before the
patent was issued), FDA’s determination
of the length of a regulatory review
period for a human drug product will
include all of the testing phase and
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA recently approved for marketing
the human drug product PROMACTA
(eltrombopag olamine). PROMACTA is
indicated the treatment of
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13:40 Jun 09, 2010
Jkt 220001
thrombocytopenia in patients with
chronic immune (idiopathic)
thrombocytopenic purpura who have
had an insufficient response to
corticosteroids, immunoglobulins, or
splenectomy. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for PROMACTA (U.S. Patent
No. 7,160,870) from SmithKline
Beecham Corp. (DBA GlaxoSmithKline),
and the Patent and Trademark Office
requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
September 29, 2009, FDA advised the
Patent and Trademark Office that this
human drug product had undergone a
regulatory review period and that the
approval of PROMACTA represented
the first permitted commercial
marketing or use of the product.
Thereafter, the Patent and Trademark
Office requested that FDA determine the
product’s regulatory review period.
FDA has determined that the
applicable regulatory review period for
PROMACTA is 1,485 days. Of this time,
1,147 days occurred during the testing
phase of the regulatory review period,
while 338 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
355(i)) became effective: October 29,
2004. The applicant claims October 28,
2004, as the date the investigational new
drug application (IND) became effective.
However, FDA records indicate that the
IND effective date was October 29, 2004,
which was 30 days after FDA receipt of
the IND.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: December 19, 2007.
FDA has verified the applicant’s claim
that the new drug application (NDA)
22–291 was submitted on December 19,
2007.
3. The date the application was
approved: November 20, 2008. FDA has
verified the applicant’s claim that NDA
22–291 was approved on November 20,
2008.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 347 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
PO 00000
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submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments and ask for a
redetermination by August 9, 2010.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
December 7, 2010. To meet its burden,
the petition must contain sufficient facts
to merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
Comments and petitions should be
submitted to the Division of Dockets
Management. Three copies of any
mailed information are to be submitted,
except that individuals may submit one
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. Comments and petitions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: April 23, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2010–13905 Filed 6ndash;9–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0281]
Draft Guidance for Industry and Food
and Drug Administration Staff;
‘‘‘Harmful and Potentially Harmful
Constituents’ in Tobacco Products as
Used in Section 904(e) of the Federal
Food, Drug, and Cosmetic Act’’;
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 and FDA staff entitled
‘‘‘Harmful and Potentially Harmful
Constituents’ in Tobacco Products as
Used in Section 904(e) of the Federal
Food, Drug, and Cosmetic Act.’’ This
draft guidance provides written
guidance to industry and FDA staff on
certain provisions of the Family
Smoking Prevention and Tobacco
Control Act (Tobacco Control Act).
DATES: Although you can comment on
any guidance at any time (see 21 CFR
E:\FR\FM\10JNN1.SGM
10JNN1
Federal Register / Vol. 75, No. 111 / Thursday, June 10, 2010 / Notices
cprice-sewell on DSK8KYBLC1PROD with NOTICES
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by September 8,
2010.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Center for Tobacco Products, Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850–3229. Send
one self-addressed adhesive label to
assist that office in processing your
requests or include a fax number to
which the draft guidance document may
be sent. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments to https://
www.regulations.gov. 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. Identify comments with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Carol Drew, Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850–3229, 877–287–
1373.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry and FDA
staff entitled ‘‘‘Harmful and Potentially
Harmful Constituents’ in Tobacco
Products as Used in Section 904(e) of
the Federal Food, Drug, and Cosmetic
Act.’’ This draft guidance, when
finalized, will discuss the meaning of
the term ‘‘harmful and potentially
harmful constituent’’ for use in
implementing section 904(e) of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 387d(e)) as amended
by the Tobacco Control Act.
On June 22, 2009, the President
signed the Tobacco Control Act (Public
Law 111–310) into law. The Tobacco
Control Act amended the act (21 U.S.C.
301 et seq.) by, among other things,
adding a new chapter granting FDA
important new authority to regulate the
manufacture, marketing, and
distribution of tobacco products to
protect the public health generally and
to reduce tobacco use by minors.
Section 904(e) of the act, as added by
the Tobacco Control Act, requires FDA
to establish, and periodically revise as
appropriate, ‘‘a list of harmful and
potentially harmful constituents,
including smoke constituents, to health
VerDate Mar<15>2010
13:40 Jun 09, 2010
Jkt 220001
in each tobacco product by brand and
by quantity in each brand and
subbrand.’’ The draft guidance discusses
the meaning of the term ‘‘harmful and
potentially harmful constituent’’ in the
context of implementing the listing
requirements of section 904(e) of the act.
II. Significance of Guidance
This draft guidance is being issued as
a level 1 guidance 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 certain
provisions of the Tobacco Control Act.
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.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments 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.regulations.gov or https://
www.fda.gov/TobaccoProducts/
GuidanceComplianceRegulatory
Information/default.htm.
Dated: June 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–14046 Filed 6–8–10; 4:15 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0282]
Guidance for Industry and Food and
Drug Administration Staff; Use of
‘‘Light,’’ ‘‘Mild,’’ ‘‘Low,’’ or Similar
Descriptors in the Label, Labeling, or
Advertising of Tobacco Products;
Availability
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
ACTION:
32953
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘Use of ‘Light,’ ‘Mild,’ ‘Low,’ or Similar
Descriptors in the Label, Labeling, or
Advertising of Tobacco Products.’’ This
guidance provides information on the
Family Smoking Prevention and
Tobacco Control Act’s (Tobacco Control
Act) requirements related to the use of
‘‘light,’’ ‘‘mild,’’ ‘‘low,’’ or similar
descriptors in the label, labeling, or
advertising of tobacco products. This
guidance document will be
implemented immediately, but it
remains subject to comment in
accordance with the agency’s good
guidance practices.
DATES: Submit either electronic or
written comments on this guidance at
any time. General comments on agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the guidance document
entitled ‘‘Use of ‘Light,’ ‘Mild,’ ‘Low,’ or
Similar Descriptors in the Label,
Labeling, or Advertising of Tobacco
Products’’ to the Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850–3229. Send one
self-addressed adhesive label to assist
that office in processing your request or
include a fax number to which the
guidance document may be sent. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance.
Submit electronic comments to https://
www.regulations.gov. Submit written
comments concerning this guidance to
the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Beth
Buckler, Center for Tobacco
Products,Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 1–877–287–1373,
e-mail: beth.buckler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On June 22, 2009, the President
signed the Tobacco Control Act (Public
Law 111–31) into law. The Tobacco
Control Act grants FDA authority to
regulate the manufacture, marketing,
and distribution of tobacco products to
protect the public health generally and
to reduce tobacco use by minors.
E:\FR\FM\10JNN1.SGM
10JNN1
]]>Agencies
[Federal Register Volume 75, Number 111 (Thursday, June 10, 2010)]
[Notices]
[Pages 32952-32953]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14046]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0281]
Draft Guidance for Industry and Food and Drug Administration
Staff; ```Harmful and Potentially Harmful Constituents' in Tobacco
Products as Used in Section 904(e) of the Federal Food, Drug, and
Cosmetic Act''; 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 and FDA staff entitled
```Harmful and Potentially Harmful Constituents' in Tobacco Products as
Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act.''
This draft guidance provides written guidance to industry and FDA staff
on certain provisions of the Family Smoking Prevention and Tobacco
Control Act (Tobacco Control Act).
DATES: Although you can comment on any guidance at any time (see 21
CFR
[[Page 32953]]
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 8, 2010.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Center for Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229. Send
one self-addressed adhesive label to assist that office in processing
your requests or include a fax number to which the draft guidance
document may be sent. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
Submit electronic comments to https://www.regulations.gov. 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. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Carol Drew, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850-3229, 877-287-1373.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
and FDA staff entitled ```Harmful and Potentially Harmful Constituents'
in Tobacco Products as Used in Section 904(e) of the Federal Food,
Drug, and Cosmetic Act.'' This draft guidance, when finalized, will
discuss the meaning of the term ``harmful and potentially harmful
constituent'' for use in implementing section 904(e) of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 387d(e)) as amended
by the Tobacco Control Act.
On June 22, 2009, the President signed the Tobacco Control Act
(Public Law 111-310) into law. The Tobacco Control Act amended the act
(21 U.S.C. 301 et seq.) by, among other things, adding a new chapter
granting FDA important new authority to regulate the manufacture,
marketing, and distribution of tobacco products to protect the public
health generally and to reduce tobacco use by minors. Section 904(e) of
the act, as added by the Tobacco Control Act, requires FDA to
establish, and periodically revise as appropriate, ``a list of harmful
and potentially harmful constituents, including smoke constituents, to
health in each tobacco product by brand and by quantity in each brand
and subbrand.'' The draft guidance discusses the meaning of the term
``harmful and potentially harmful constituent'' in the context of
implementing the listing requirements of section 904(e) of the act.
II. Significance of Guidance
This draft guidance is being issued as a level 1 guidance
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 certain provisions of the Tobacco Control
Act. 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.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments 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.regulations.gov or https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.
Dated: June 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-14046 Filed 6-8-10; 4:15 pm]
BILLING CODE 4160-01-S
