Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices 53233 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of Respondents Annual Frequency per 

Response Total Annual Responses Hours per response Total Hours Operating and Maintenance Costs 

40 1 40 780 31,200 $5,500 

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

No. of Recordkeepers Annual Frequency per 

Recordkeeping Total Annual Records Hours per Record Total Hours Operating and Maintenance Costs 

40 1 40 2,800 112,000 $60,700 

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

Based on previous years’ experience 

with CLIA waiver applications, FDA 

expects 40 manufacturers to apply for 

one CLIA waiver per year. The annual 

reporting burden to respondents is 

estimated to be 31,200 hours, and 

recordkeeping burdens for respondents 

is estimated to be 112,000 hours. FDA 

based the reporting and recordkeeping 

burden on an agency analysis of 

premarket submissions with clinical 

trials similar to the waived laboratory 

tests. 

The total operating and maintenance 

cost associated with the implementation 

of this draft guidance is estimated to be 

$66,200. The cost consists of specimen 

collection for the clinical study 

(estimated at $23,500); laboratory 

supplies, reference testing and study 

oversight (estimated $26,700); shipping 

and office supplies (estimated $6,000); 

and educational materials, including 

quick reference instructions ($10,000). 

V. 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. 

Dated: August 31, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–17732 Filed 9–1–05; 4:00 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005D–0334] 

Draft Guidance for Industry on the 

Pediatric Research Equity 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 entitled ‘‘How to Comply with 

the Pediatric Research Equity Act.’’ This 

draft guidance provides 

recommendations on how to interpret 

the requirements of the Pediatric 

Research Equity Act (PREA), which 

requires pediatric studies of certain 

drugs and biological products to ensure 

that those products that are likely to be 

commonly used in children or that 

represent a meaningful therapeutic 

benefit over existing treatments contain 

adequate pediatric labeling for approved 

indications. 

DATES: Submit written or electronic 

comments on the draft guidance by 

November 7, 2005. 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; or to the Office of 

Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

that office in processing your requests. 

The draft guidance may also be obtained 

by mail by calling CBER at 1–800–835–

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 http://www.fda.gov/dockets/ 

ecomments. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Grace Carmouze, Center for Drug 

Evaluation and Research (HFD–

950), Food and Drug 

Administration,5600 Fishers Lane, 

Rockville, MD 20857, 301–594–

2041, or 

Leonard Wilson, Center for Biologics 

Evaluation and Research (HFM–25), 

Food and Drug Administration, 

1401 Rockville Pike, suite 200N 

Rockville, MD 20852–1448, 301–

827–0373. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘How to Comply with the Pediatric 

Research Equity Act.’’ On December 3, 

2003, the Pediatric Research Equity Act 

was signed into law. PREA amends the 

Federal Food, Drug, and Cosmetic Act 

(the act) by adding section 505B (21 

U.S.C. 355B). In PREA, Congress 

codified many of the elements of the 

Pediatric Rule, a final rule issued by 

FDA on December 2, 1998 (63 FR 

66632), and suspended by court order 

on October 17, 2002. Association of 

American Physicians, and Surgeons, 

Inc. v. FDA, 226 F. Supp. 2d 204 (D.D.C. 

2002). Specifically, PREA, in adding 

section 505B(a) of the act, requires all 

applications (or supplements to an 

application) submitted under section 

505 of the act (21 U.S.C. 355) or section 

351 of the Public Health Service Act 

(PHS Act) (42 U.S.C. 262) for a new 

active ingredient, new indication, new 

dosage form, new dosing regimen, or 

53234 Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices 

new route of administration to contain 

a pediatric assessment unless the 

applicant has obtained a waiver or 

deferral. PREA also authorizes FDA, 

under section 505B(b) of the act, to 

require holders of previously approved 

applications for marketed drugs and 

biological products to conduct pediatric 

studies under certain circumstances, 

even if the holders are not seeking one 

of the changes listed under section 

505B(a) of the act. This draft guidance 

only provides recommendations related 

to studies required under section 

505B(a) of the act.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 how to comply with 

PREA. 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 on the draft guidance. 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 are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

(44 U.S.C. 3501–3520) (the PRA), 

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 

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 

comment on: (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 on respondents, 

including through the use of automated 

collection techniques, when 

appropriate, and other forms of 

information technology. 

Title: Draft Guidance for Industry: 

How to Comply with the Pediatric 

Research Equity Act. 

Description: The draft guidance 

provides recommendations to sponsors 

on how to interpret the requirements of 

PREA. PREA requires new drug 

applications (NDAs) and biologics 

licensing applications (BLAs) (or 

supplements to an applications) for a 

new active ingredient, new indication, 

new dosage form, new dosing regimen, 

or new route of administration to 

contain a pediatric assessment unless 

the applicant has obtained a waiver or 

deferral. Although PREA applies to both 

new applications (or supplements to an 

application) and currently marketed 

drugs and biological products for which 

a sponsor is not seeking one of the 

enumerated changes, the guidance only 

provides recommendations related to 

new applications or supplements to 

applications for drugs and biological 

products. 

Description of Respondents: Sponsors 

of NDAs or BLAs for human drugs and 

biological products. 

Burden Estimate: FDA is requesting 

public comments on estimates of annual 

submissions expected in 2005 (based on 

the number of submissions received in 

2003 and 2004 unless otherwise 

indicated) as required by the following 

PREA requirements described in the 

draft guidance: 

Section 505B(a)(1) and (a)(2)—The 

draft guidance provides 

recommendations for submitting 

pediatric studies with applications (or 

supplements to an application) for a 

new active ingredient, new indication, 

new dosage form, new dosing regimen, 

or new route of administration under 

section 505 of the act or section 351 of 

the PHS Act. These assessments are 

required to contain data that are 

adequate to assess the safety and 

effectiveness of the drug product for the 

claimed indications in the relevant 

pediatric subpopulations and to support 

dosing and administration for each 

subpopulation for which the product is 

safe and effective. FDA estimates that 

106 pediatric use assessments will be 

submitted from 78 applicants and it will 

take 50 hours to prepare each 

assessment. 

Section 505B(a)(3)—The draft 

guidance makes recommendations on 

how to request a deferral of some or all 

assessments of safety and effectiveness 

required under PREA. FDA estimates 

that it will receive 160 requests to defer 

assessments from 54 applicants and it 

will take 24 hours to prepare each 

request. 

Section 505B(a)(4)—The draft 

guidance provides recommendations on 

how to request a full or partial waiver 

of the pediatric study requirements. 

Based on its 2003 and 2004 experience, 

FDA anticipates that it will receive 

approximately 110 requests annually 

from approximately 80 applicants and 

estimates it will take approximately 8 

hours to prepare each request. 

Section 505B(e)—The draft guidance 

makes recommendations for applicants 

to meet at appropriate times with FDA 

to discuss plans and timelines for 

pediatric studies and any planned 

requests for deferral or waiver of 

pediatric studies. FDA estimates it will 

receive 160 submissions associated with 

meetings to discuss pediatric plans from 

95 applicants at 16 hours per meeting 

submission. 

FDA estimates that the collection of 

information resulting from this draft 

guidance is as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN

PREA Provision Number of Respondents Number of Responses 

per Respondent 

Total Annual 

Responses 

Hours per 

Response Total Hours 

505B(a)(1) and (a)(2) Submission of pediatric assessments 78 1 .4 106 50 5,300 

Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices 53235 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN—Continued 

PREA Provision Number of Respondents Number of Responses 

per Respondent 

Total Annual 

Responses 

Hours per 

Response Total Hours 

505B(a)(3) Deferrals 54 3 .0 160 24 3,840 

505B(a)(4) Full and partial 

waivers 80 1 .4 110 8 880 

505B(e) Meetings 95 1 .7 160 16 2,560 

Total 12,580 

In addition, the draft guidance 

discusses when sponsors may need to 

report on the status of postmarketing 

study commitments as part of annual 

reports submitted under 21 CFR 

314.81(b) and 21 CFR 601.70. The 

burdens associated with the annual 

reporting requirements were previously 

accounted for under OMB number 

0910–0001 (expires 5/31/08) (for 21 CFR 

314.81(b) and OMB number 0910–0433 

(expires 3/31/07) (for 21 CFR 601.70). 

Furthermore, although labeling 

submissions are required under certain 

PREA provisions (e.g., section 

505B(a)(4)(D) of the act), the draft 

guidance does not provide 

recommendations on these requirements 

and therefore FDA has not estimated 

associated burdens. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.fda.gov/cder/guidance/index.htm, 

http://www.fda.gov/cber/ 

guidelines.htm, or http://www.fda.gov/ 

ohrms/dockets/default.htm. 

Dated: August 29, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–17694 Filed 9–6–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

Notice of 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 a meeting of the 

National Advisory Council on Drug 

Abuse. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the 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 Advisory 

Council on Drug Abuse. 

Date: September 21, 2005. 

Closed: 9 a.m. to 11:30 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. 

Open: 1 p.m. to 4 p.m. 

Agenda: This portion of the meeting will 

be open to the public for announcements and 

reports of administrative, legislative and 

program developments in the drug abuse 

field. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. 

Contact Person: Teresa Levitin, PhD, 

Director, Office of Extramural Affairs, 

National Institute on Drug Abuse, NIH, 

DHHS, Room 220, MSC 8401, 6101 Executive 

Boulevard, Bethesda, MD 20892–8401, (301) 

433–2755. 

Any member of the public interested in 

presenting oral comments to the committee 

may notify the Contact Person listed on this 

notice at least 10 days in advance of the 

meeting. Interested individuals and 

representatives of organizations may submit 

a letter of intent, a brief description of the 

organization represented, and a short 

description of the oral presentation. Only one 

representative of an organization may be 

allowed to present oral comments and if 

accepted by the committee, presentations 

may be limited to five minutes. Both printed 

and electronic copies are requested for the 

record. In addition, any interested person 

may file written comments with the 

committee by forwarding their statement to 

the Contact Person listed on this notice. The 

statement should include the name, address, 

telephone number and when applicable, the 

business or professional affiliation of the 

interested person. 

Information is also available on the 

Institute’s/Center’s Home page: http:// 

www.drugabuse.gov/NACDA/ 

NACDAHome.html, where an agenda and 

any additional information for the meeting 

will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.277, Drug Abuse Scientist 

Development Award for Clinicians, Scientist 

Development Awards, and Research Scientist 

Awards; 93.278, Drug Abuse National 

Research Service Awards for Research 

Training; 93.279, Drug Abuse Research 

Programs, National Institutes of Health, HHS) 

Dated: August 29, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–17682 Filed 9–6–05; 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, Review of Heart Study 

Applications (UO1s). 

Date: September 13, 2005.