Draft Guidance for Industry on Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms-Recommended Prescribing Information for Health Care Providers and Patient Labeling; Availability, 69578-69579 [05-22754]
Download as PDF
<![CDATA[
69578
Federal Register / Vol. 70, No. 220 / Wednesday, November 16, 2005 / Notices
The burden estimate for this
collection of information is based on
past filings. Agency personnel
responsible for processing the filing of
objections and requests for a public
hearing on a specific regulation or order
estimate approximately 10 requests are
received by the agency annually, with
each requiring approximately 20 hours
of preparation time.
Dated: November 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–22753 Filed 11–15–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 1998D–0834 (formerly Docket
No. 98D–0834]
Draft Guidance for Industry on
Noncontraceptive Estrogen Drug
Products for the Treatment of
Vasomotor Symptoms and Vulvar and
Vaginal Atrophy Symptoms—
Recommended Prescribing
Information for Health Care Providers
and Patient Labeling; 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availability of a draft guidance for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 ‘‘Noncontraceptive
Estrogen Drug Products for the
Treatment of Vasomotor Symptoms and
Vulvar and Vaginal Atrophy
Symptoms—Recommended Prescribing
Information for Health Care Providers
and Patient Labeling.’’ The draft
guidance is intended to assist applicants
in developing labeling for new drug
applications (NDAs) for such drug
products. This is the fifth draft of the
guidance, which FDA initially
published for comment in October 1998.
DATES: Submit written or electronic
comments on the draft guidance by
January 17, 2006. 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single copies of the draft guidance to the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
VerDate Aug<31>2005
13:56 Nov 15, 2005
Jkt 208001
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:
Margaret Kober, Center for Drug
Evaluation and Research (5359), Food
and Drug Administration, 10903 New
Hampshire Ave., bldg. 22, rm. 5376,
Silver Spring, MD 20993, 301–796–
0934.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance entitled
‘‘Noncontraceptive Estrogen Drug
Products for the Treatment of
Vasomotor Symptoms and Vulvar and
Vaginal Atrophy Symptoms—
Recommended Prescribing Information
for Health Care Providers and Patient
Labeling.’’ The draft guidance describes
the recommended labeling for health
care providers and patient instructions
for inclusion in NDAs.
A draft of this guidance was first
issued on October 15, 1998 (63 FR
55399). After public review and
comment, a second version of this draft
guidance was issued on September 27,
1999 (64 FR 52100). On May 31, 2002,
the National Institutes of Health
Women’s Health Initiative (WHI) study
of oral conjugated estrogens (CE 0.625
milligram (mg)) plus
medroxyprogesterone acetate (MPA 2.5
mg)/day in postmenopausal women was
stopped after a mean of 5.2 years of
followup because test statistics for
invasive breast cancer exceeded the
stopping boundary for this adverse
effect and the global index statistic
supported risks exceeding benefits. Data
on the major clinical outcomes
regarding increased risks for invasive
breast cancer, heart attacks, strokes, and
venous thromboembolism rates,
including pulmonary embolism, became
available July 17, 2002. Consequently,
the agency withdrew the draft guidance
on September 10, 2002 (67 FR 57432),
pending consideration of the results
from the WHI study. In the Federal
Register of February 3, 2003 (68 FR
5300), the agency issued a third draft
reflecting the agency’s thinking after
consideration of the results from the
WHI study concerning overall risks and
benefits of hormone therapy for
postmenopausal symptoms.
A fourth draft of this guidance was
issued on February 17, 2004 (69 FR
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
7492), to address comments received,
incorporate new study results from the
Women’s Health Initiative Memory
Study (WHIMS), a substudy of the WHI
study, and better inform prescribers and
patients regarding the availability of the
lowest effective dose for these drug
products. (The results of the WHIMS
substudy were published on May 28,
2003. Postmenopausal women, 65 to 79
years of age, during 4 years of treatment
with CE 0.625 mg plus MPA 2.5 mg/day
had a greater risk of developing
probable dementia than those on
placebo.)
The agency is issuing this fifth draft
of the guidance to incorporate new
study results from the WHI and WHIMS
studies. This fifth draft supersedes the
fourth draft, and retains and updates the
labeling recommendations regarding the
results of the WHI study and the
WHIMS substudy for postmenopausal
women treated with CE 0.625 mg plus
MPA 2.5 mg/day. It also reflects the
agency’s thinking after consideration of
the results published on April 14, 2004,
of the WHI study, and the results
published on June 23/30, 2004, of the
WHIMS substudy for postmenopausal
women with prior hysterectomy treated
with CE 0.625 mg/day alone. The WHI
study of CE 0.625 mg/day alone in
postmenopausal women with prior
hysterectomy was stopped after a mean
followup of 6.8 years because of an
increased risk of stroke. The WHIMS
substudy of CE 0.625 mg/day alone was
stopped after a mean followup of 5.2
years. Estrogen-alone therapy did not
reduce probable dementia or cognitive
decline incidence and increased the risk
for both endpoints combined. This fifth
draft of the guidance recommends
adding risk information related to the
results of the WHI and WHIMS
estrogen-alone studies to appropriate
sections of labeling including the boxed
warning. Further revisions to the
guidance may be necessary as additional
information becomes available.
This level 1 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 labeling for
noncontraceptive estrogen drug
products for the treatment of moderate
to severe vasomotor symptoms and
moderate to severe vulvar and vaginal
atrophy symptoms. 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.
E:\FR\FM\16NON1.SGM
16NON1
Federal Register / Vol. 70, No. 220 / Wednesday, November 16, 2005 / Notices
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. The draft
guidance and received comments may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Bethesda, MD 20892–9300. (301) 451–2020.
aes@nei.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.867, Vision Research,
National Institutes of Health, HHS)
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.
National Institutes of Health
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Eye Institute; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Eye Institute
Special Emphasis Panel. NEI Clinical
applications.
Date: November 21, 2005.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road, NW.,
Washington, DC 20015.
Contact Person: Anne E. Schaffner, PhD,
Scientific Review Administrator, Division of
Extramural Research, National Eye Institute,
5635 Fishers Lane, Suite 1300, MSC 9300,
13:56 Nov 15, 2005
Jkt 208001
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Dated: November 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–22754 Filed 11–15–05; 8:45 am]
VerDate Aug<31>2005
Dated: November 4, 2005.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–22691 Filed 11–15–05; 8:45 am]
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel,
Clinical Trial Review.
Date: December 5, 2005.
Time: 12 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: William J. Johnson, PhD,
Review Branch, Division of Extramural
Affairs, NIH/NHLBI, 6701 Rockledge Drive,
Bethesda, MD 20892–7924, 301–435–0317,
johnsonw@nhibi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: November 7, 2005.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–22684 Filed 11–15–05; 8:45 am]
BILLING CODE 4140–01–M
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
69579
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (U.S.C. Appendix 2), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commerical
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel, RFA–05–015 ‘‘Clinical
Outcomes of Live Organ Donors’’.
Date: December 1–2, 2005.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Double Tree Rockville, 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: Kenneth E. Santora, PhD,
Scientific Review Administrator, Scientific
Review Program, Division of Extramural
Activities, NIAID/NIH/DHHS, Room 3265,
6700B Rockledge Drive, MSC 7616, Bethesda,
MD 20892, (301) 451–2605, ks216i@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: November 7, 2005.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–22682 Filed 11–15–05; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings will be closed to the
public in accordance with the
E:\FR\FM\16NON1.SGM
16NON1
]]>Agencies
[Federal Register Volume 70, Number 220 (Wednesday, November 16, 2005)]
[Notices]
[Pages 69578-69579]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-22754]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 1998D-0834 (formerly Docket No. 98D-0834]
Draft Guidance for Industry on Noncontraceptive Estrogen Drug
Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal
Atrophy Symptoms--Recommended Prescribing Information for Health Care
Providers and Patient Labeling; 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
``Noncontraceptive Estrogen Drug Products for the Treatment of
Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms--Recommended
Prescribing Information for Health Care Providers and Patient
Labeling.'' The draft guidance is intended to assist applicants in
developing labeling for new drug applications (NDAs) for such drug
products. This is the fifth draft of the guidance, which FDA initially
published for comment in October 1998.
DATES: Submit written or electronic comments on the draft guidance by
January 17, 2006. 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: Margaret Kober, Center for Drug
Evaluation and Research (5359), Food and Drug Administration, 10903 New
Hampshire Ave., bldg. 22, rm. 5376, Silver Spring, MD 20993, 301-796-
0934.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance entitled
``Noncontraceptive Estrogen Drug Products for the Treatment of
Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms--Recommended
Prescribing Information for Health Care Providers and Patient
Labeling.'' The draft guidance describes the recommended labeling for
health care providers and patient instructions for inclusion in NDAs.
A draft of this guidance was first issued on October 15, 1998 (63
FR 55399). After public review and comment, a second version of this
draft guidance was issued on September 27, 1999 (64 FR 52100). On May
31, 2002, the National Institutes of Health Women's Health Initiative
(WHI) study of oral conjugated estrogens (CE 0.625 milligram (mg)) plus
medroxyprogesterone acetate (MPA 2.5 mg)/day in postmenopausal women
was stopped after a mean of 5.2 years of followup because test
statistics for invasive breast cancer exceeded the stopping boundary
for this adverse effect and the global index statistic supported risks
exceeding benefits. Data on the major clinical outcomes regarding
increased risks for invasive breast cancer, heart attacks, strokes, and
venous thromboembolism rates, including pulmonary embolism, became
available July 17, 2002. Consequently, the agency withdrew the draft
guidance on September 10, 2002 (67 FR 57432), pending consideration of
the results from the WHI study. In the Federal Register of February 3,
2003 (68 FR 5300), the agency issued a third draft reflecting the
agency's thinking after consideration of the results from the WHI study
concerning overall risks and benefits of hormone therapy for
postmenopausal symptoms.
A fourth draft of this guidance was issued on February 17, 2004 (69
FR 7492), to address comments received, incorporate new study results
from the Women's Health Initiative Memory Study (WHIMS), a substudy of
the WHI study, and better inform prescribers and patients regarding the
availability of the lowest effective dose for these drug products. (The
results of the WHIMS substudy were published on May 28, 2003.
Postmenopausal women, 65 to 79 years of age, during 4 years of
treatment with CE 0.625 mg plus MPA 2.5 mg/day had a greater risk of
developing probable dementia than those on placebo.)
The agency is issuing this fifth draft of the guidance to
incorporate new study results from the WHI and WHIMS studies. This
fifth draft supersedes the fourth draft, and retains and updates the
labeling recommendations regarding the results of the WHI study and the
WHIMS substudy for postmenopausal women treated with CE 0.625 mg plus
MPA 2.5 mg/day. It also reflects the agency's thinking after
consideration of the results published on April 14, 2004, of the WHI
study, and the results published on June 23/30, 2004, of the WHIMS
substudy for postmenopausal women with prior hysterectomy treated with
CE 0.625 mg/day alone. The WHI study of CE 0.625 mg/day alone in
postmenopausal women with prior hysterectomy was stopped after a mean
followup of 6.8 years because of an increased risk of stroke. The WHIMS
substudy of CE 0.625 mg/day alone was stopped after a mean followup of
5.2 years. Estrogen-alone therapy did not reduce probable dementia or
cognitive decline incidence and increased the risk for both endpoints
combined. This fifth draft of the guidance recommends adding risk
information related to the results of the WHI and WHIMS estrogen-alone
studies to appropriate sections of labeling including the boxed
warning. Further revisions to the guidance may be necessary as
additional information becomes available.
This level 1 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
labeling for noncontraceptive estrogen drug products for the treatment
of moderate to severe vasomotor symptoms and moderate to severe vulvar
and vaginal atrophy symptoms. 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.
[[Page 69579]]
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. The draft guidance and 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: November 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-22754 Filed 11-15-05; 8:45 am]
BILLING CODE 4160-01-S
