45460 Federal Register / Vol. 73, No. 151 / Tuesday, August 5, 2008 / Notices 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: Jill 

Hartzler Warner, Office of Policy, 

Planning, and Preparedness (HF–11), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–3370. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a document entitled ‘‘Guidance for the 

Public, FDA Advisory Committee 

Members, and FDA Staff: Public 

Availability of Advisory Committee 

Members’ Financial Interest Information 

and Waivers,’’ dated August 2008. 

FDA’s advisory committees provide 

independent and expert advice on 

scientific, technical, and policy matters 

related to the development and 

evaluation of products regulated by 

FDA. FDA implements a rigorous 

process for soliciting and vetting 

candidates for advisory committee 

meetings to minimize any potential for 

financial conflicts of interest. The 

agency is authorized by statute to grant 

waivers to allow individuals with 

potentially conflicting financial 

interests to participate in meetings 

where we conclude, after close scrutiny, 

that certain criteria are met. See 18 

U.S.C. 208(b)(1), (b)(3) and section 

712(c)(2)(B) of the Federal Food, Drug, 

and Cosmetic Act (the act) (added by the 

Food and Drug Administration 

Amendments Act of 2007, Public Law 

No. 110–85, section 701 (effective 

October 1, 2007)). 

In January 2002, FDA issued ‘‘Draft 

Guidance on Disclosure of Conflicts of 

Interest for Special Government 

Employees Participating in FDA Product 

Specific Advisory Committees,’’ and 

requested comments on the draft 

guidance (Docket No. 2002D–0049). The 

draft guidance was limited in 

application to Special Government 

Employees (SGEs) participating in 

advisory committee meetings at which 

particular matters relating to particular 

products were discussed. 

FDA has recently undertaken an 

internal assessment of its advisory 

committee process. As a result of this 

review, and based on the comments 

submitted to the docket for the January 

2002 draft guidance, FDA has revised 

the 2002 draft guidance to broaden its 

applicability, to bring as much 

transparency as possible to FDA’s 

waiver process, and to increase the 

consistency and clarity of the process. 

The guidance revises procedures, 

consistent with section 712(c)(3) of the 

act, to make publicly available relevant 

information regarding financial interests 

and waivers granted by the agency for 

SGEs and regular Government 

employees invited to participate in FDA 

advisory committee meetings. 

The guidance also includes a template 

for disclosing to the public the 

disqualifying financial interests for 

which waivers are sought and a 

template for all waivers that FDA grants. 

The guidance further describes FDA’s 

process for making these documents 

available on its Web site in advance of 

each advisory committee meeting. 

In the Federal Register of October 31, 

2007 (72 FR 61657), FDA announced the 

availability of the draft guidance of the 

same title dated October 2007. FDA 

received one comment on the draft 

guidance generally supporting the 

guidance. Editorial changes were made 

to improve clarity. 

This guidance document is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The guidance document 

represents the agency’s current thinking 

on public availability of information 

regarding advisory committee members’

financial interests and waivers granted 

by FDA to permit participation in 

advisory committee meetings. 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, at any time, 

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. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.fda.gov/opacom/morechoices/ 

industry/guidedc.htm or http:// 

www.regulations.gov. 

Dated: July 31, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–17999 Filed 8–4–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0434] 

Draft Guidance for Humanitarian 

Device Exemption Holders, 

Institutional Review Boards, Clinical 

Investigators, and Food and Drug 

Administration Staff; Humanitarian 

Device Exemption Regulation: 

Questions and Answers; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Humanitarian Device 

Exemption (HDE) Regulation: Questions 

and Answers.’’ This draft guidance 

answers commonly asked questions 

about Humanitarian Use Devices 

(HUDs) and applications for HDE. This 

draft guidance is neither final nor is it 

in effect at this time. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

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 

written or electronic comments on the 

draft guidance by November 3, 2008. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Humanitarian 

Device Exemption (HDE) Regulation: 

Questions and Answers’’ to the Division 

of Small Manufacturers, International, 

and Consumer Assistance (HFZ–220), 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

1350 Piccard Dr., Rockville, MD 20850. 

Send one self-addressed adhesive label 

to assist that office in processing your 

request, or fax your request to 240–276–

3151. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit written comments concerning 

this draft guidance to the Division of 


dwashington3 on PRODPC61 with NOTICES
Federal Register / Vol. 73, No. 151 / Tuesday, August 5, 2008 / Notices 45461 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.regulations.gov. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Stephen P. Rhodes, Center for Devices 

and Radiological Health (HFZ–403), 

Food and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

240–276–4036. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This draft guidance answers 

commonly asked questions about HUDs 

and applications for HDE authorized by 

section 510(m)(2) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 360(m)(2)). This update of the 

version issued in 2006 reflects the 

additional requirements set forth in the 

Pediatric Medical Device Safety and 

Improvement Act of 2007 (Public Law 

110–85). The Pediatric Medical Device 

Safety and Improvement Act of 2007 

includes a provision requiring that all 

original HDE applications include both 

a description of any pediatric 

subpopulations that suffer from the 

disease or condition that the device is 

intended to treat, diagnose, or cure, and 

the number of affected pediatric patients 

(new 515A(a)(2) of the act). It also 

amends section 520(m) of the act (21 

U.S.C. 360j(m)) to exempt some HUDs 

from the prohibition on profit (new 

section 520(m)(6) of the act). 

Specifically, HDE applications indicated 

for use in pediatric patients that are 

approved on or after September 27, 

2007, may be assigned an annual 

distribution number (ADN) and be sold 

for profit, subject to certain restrictions. 

Finally, the Pediatric Medical Device 

Safety and Improvement Act of 2007 

includes a provision requiring that the 

agency provide guidance to Institutional 

Review Boards (IRBs) on the review of 

HUDs. This update of the HDE guidance 

includes 30 specific questions and 

answers for IRBs, as well as guidance to 

HDE holders on whether and how they 

may become eligible to receive profit 

from the sale of their device. 

II. Significance of Guidance 

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 the aspects of HDE regulation 

discussed in the guidance. 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 statute and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by using 

the Internet. To receive ‘‘Humanitarian 

Device Exemption (HDE) Regulation: 

Questions and Answers,’’ you may 

either send an e-mail request to 

dsmica@fda.hhs.gov to receive an 

electronic copy of the document or send 

a fax request to 240–276–3151 to receive 

a hard copy. Please use the document 

number 1666 to identify the guidance 

you are requesting. 

CDRH maintains an entry on the 

Internet for easy access to information 

including text, graphics, and files that 

may be downloaded to a personal 

computer with Internet access. Updated 

on a regular basis, the CDRH home page 

includes device safety alerts, Federal 

Register reprints, information on 

premarket submissions (including lists 

of approved applications and 

manufacturers’ addresses), small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

at http://www.regulations.gov. 

IV. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

of 1995 (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 

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. 

Title: Pediatric Use Information to 

Accompany Humanitarian Device 

Exemption Applications. 

Description: Title III of the Food and 

Drug Administration Amendments Act 

of 2007 (FDAAA) (Public Law 110–85) 

amended chapter V of the act (21 U.S.C. 

351 et seq.) by inserting section 515A 

Pediatric Uses of Devices (21 U.S.C. 

360e-1). 

This new provision requires that new 

applications under section 520(m) of the 

act include both a description of any 

pediatric subpopulations that suffer 

from the disease or condition that the 

device is intended to treat, diagnose, or 

cure, and the number of affected 

pediatric patients. 

Title III of FDAAA also amended 

section 520(m) of the act as follows: 

• Section 520(m)(6)(A)(ii) provides 

that the Secretary of Health and Human 

Services will assign an annual 

distribution number for devices 

indicated for use in pediatric patients or 

in a pediatric subpopulation. The ADN 

shall be based on the following 

information in an HDE application: (1) 

the number of individuals affected by 

the disease or condition that such 

device is intended to treat, diagnose, or 

cure, and of that number; (2) the number 

of individuals likely to use the device; 

and (3) the number of devices 

reasonably necessary to treat such 

individuals. 

• Section 520(m)(6)(A)(iii) provides 

that an HDE holder immediately notify 

the agency if the number of devices 

distributed during any calendar year 

exceeds the annual distribution number. 

• Section 520(m)(6)(C) provides that 

an HDE holder may petition to modify 

the annual distribution number if 

additional information on the number of 

individuals affected by the disease or 

condition arises. 

The proposed collections of 

information are necessary to satisfy the 

previously mentioned statutory 

requirements. 

Respondents to this collection of 

information are holders of HDEs 


dwashington3 on PRODPC61 with NOTICES
45462 Federal Register / Vol. 73, No. 151 / Tuesday, August 5, 2008 / Notices 

indicated for use in pediatric patients or 

in a pediatric subpopulation that were 

approved on or after September, 27, 

2007, the enactment date of the 

Pediatric Medical Device Safety and 

Improvement Act of 2007. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

Section of the Federal Food, 

Drug, and Cosmetic Act 

No. of 

Applicants 

Annual Frequency 

per Response 

Total Annual 

HDE Applications 

Hours per 

Response Total Hours 

515A(a)(2) 5 1 5 100 500 

520(m)(6)(A)(ii) 3 1 3 50 150 

520(m)(6)(A)(iii) 1 1 1 100 100 

520(m)(6)(C) 5 1 5 100 500 

Total 1,250 

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

FDA based these estimates on the 

number of original HDE applications 

that the Center for Devices and 

Radiological Health (CDRH) received in 

the period between October 1, 2004, and 

September 30, 2007. During that time, 

CDRH received 16 original HDE 

applications or about 5 per year. 

FDA estimates that for each year 

CDRH will receive five HDE 

applications and that three of these 

applications will be indicated for 

pediatric use. One HDE holder will 

notify the agency that the number of 

devices distributed in the year has 

exceeded the annual distribution 

number and five HDE holders will 

petition to have the annual distribution 

number modified due to additional 

information on the number of 

individuals affected by the disease or 

condition. 

This draft guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

The collections of information in 21 

CFR part 803 have been approved under 

OMB control number 0910–0437; the 

collections of information in 21 CFR 

part 812 have been approved under 

OMB control number 0910–0078; the 

collections of information in 21 CFR 

part 807, subpart E have been approved 

under OMB control number 0910–0120; 

the collections of information in 21 CFR 

part 814, subparts A, B, and C have been 

approved under OMB control number 

0910–0231; the collections of 

information in 21 CFR parts 50 and 56 

have been approved under OMB control 

number 0910–0130; the collections of 

information in 21 CFR part 820 have 

been approved under OMB control 

number 0910–0073; the collections of 

information in 21 CFR part 814, subpart 

H have been approved under OMB 

control number 0910–0332; and the 

collections of information in 21 CFR 

10.30 have been approved under OMB 

control number 0910–0183. 

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. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

Dated: July 30, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–17905 Filed 8–4–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0386] 

International Conference on 

Harmonisation; Draft Guidance on E2F 

Development Safety Update Report; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘E2F Development Safety Update 

Report.’’ The draft guidance was 

prepared under the auspices of the 

International Conference on 

Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use (ICH). 

The draft guidance describes the format, 

content, and timing of a development 

safety update report (DSUR) for an 

investigational drug. The DSUR would 

serve as a harmonized, annual clinical 

trial safety report that would be 

standard among the three ICH regions. 

The DSUR could be submitted in the 

United States in place of an annual 

report for an investigational new drug 

application (IND). The harmonized 

DSUR is intended to promote a 

consistent approach to annual clinical 

safety reporting among the ICH regions 

and enhance efficiency by reducing the 

number of reports generated for 

submission to the regulatory authorities. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

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 

written or electronic comments on the 

draft guidance by November 3, 2008. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002; or the 

Office of Communication, Training and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), Food and Drug 

Administration, 1401 Rockville Pike, 


dwashington3 on PRODPC61 with NOTICES