Federal Register / Vol. 70, No. 220 / Wednesday, November 16, 2005 / Notices 69577 

Dated: November 8, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–22671 Filed 11–15–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0427] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Filing Objections 

and Requests for a Hearing on a 

Regulation or Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

requirements for filing objections and 

requests for a hearing on a regulation or 

order. 

DATES: Submit written or electronic 

comments on the collection of 

information by January 17, 2006. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/ 

dockets/ecomments. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–4659. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Filing Objections and Requests for a 

Hearing on a Regulation or Order—21 

CFR Part 12 (OMB Control Number 

0910–0184)—Extension 

Under part 12 (21 CFR part 12), 

§ 12.22, issued under section 701(e)(2) 

of the Federal Food, Drug, and Cosmetic 

Act (the act) (21 U.S.C. 371(e)(2)), sets 

forth the instructions for filing 

objections and requests for a hearing on 

a regulation or order under § 12.20(d). 

Objections and requests must be 

submitted within the time specified in 

§ 12.20(e). Each objection for which a 

hearing has been requested must be 

separately numbered and specify the 

provision of the regulation or the 

proposed order. In addition, each 

objection must include a detailed 

description and analysis of the factual 

information and any other document, 

with some exceptions, supporting the 

objection. Failure to include this 

information constitutes a waiver of the 

right to a hearing on that objection. FDA 

uses the description and analysis to 

determine whether a hearing request is 

justified. The description and analysis 

may be used only for the purpose of 

determining whether a hearing has been 

justified under § 12.24 and do not limit 

the evidence that may be presented if a 

hearing is granted. 

Respondents to this information 

collection are those parties that may be 

adversely affected by an order or 

regulation. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

12.22 10 1 10 20 200 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

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.