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Draft Guidance for Industry on 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availability of a draft guidance for 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comments on the draft guidance by 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single copies of the draft guidance to the 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 

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 http:// 

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. 

Federal Register / Vol. 70, No. 220 / Wednesday, November 16, 2005 / Notices 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 

http://www.fda.gov/cder/guidance/ 

index.htm or http://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 

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, 

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) 

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] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

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 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 

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