Federal Register / Vol. 73, No. 186 / Wednesday, September 24, 2008 / Notices 55111 

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued 

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

211.80(d) 4,184 .25 1,046 .1 105 

211.100(b) 4,184 3 12,552 2 25,104 

211.105(b) 4,184 .25 1,046 .25 262 

211.122(c) 4,184 50 209,200 .25 52,300 

211.130(e) 4,184 50 209,200 .25 52,300 

211.132(c) 1,698 20 33,960 .5 16,980 

211.132(d) 1,698 .2 340 .5 170 

211.137 4,184 5 20,920 .5 10,460 

211.160(a) 4,184 2 8,368 1 8,368 

211.165(e) 4,184 1 4,184 1 4,184 

211.166(c) 4,184 2 8,368 .5 4,184 

211.173 1,077 1 1,077 .25 269 

211.180(e) 4,184 .2 837 .25 209 

211.180(f) 4,184 .2 837 1 837 

211.182 4,184 2 8,368 .25 2,092 

211.184 4,184 3 12,552 .5 6,276 

211.186 4,184 10 41,840 2 83,680 

211.188 4,184 25 104,600 2 209,200 

211.192 4,184 2 8,368 1 8,368 

211.194 4,184 25 104,600 .5 52,300 

211.196 4,184 25 104,600 .25 26,150 

211.198 4,184 5 20,920 1 20,920 

211.204 4,184 10 41,840 .5 20,920 

Total 848,625 

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

Dated: September 18, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–22435 Filed 9–23–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0077] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; MedWatch: Food 

and Drug Administration Medical 

Products Reporting Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995 

(the PRA). 

DATES: Fax written comments on the 

collection of information by October 24, 

2008. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

baguilar@omb.eop.gov. All comments 

should be identified with the OMB 

control number 0910–0291. 


jlentini on PROD1PC65 with NOTICES
55112 Federal Register / Vol. 73, No. 186 / Wednesday, September 24, 2008 / Notices 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management (HFA–710), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–796–3792. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

MedWatch: Food and Drug 

Administration Medical Products 

Reporting Program (OMB Control 

Number 0910–0291)—Extension 

Under sections 505, 512, 513, 515, 

and 903 of the Federal Food, Drug, and 

Cosmetic Act (the act); (21 U.S.C. 355, 

360b, 360c, 360e, and 393); and section 

351 of the Public Health Service Act (42 

U.S.C. 262), FDA has the responsibility 

to ensure the safety and effectiveness of 

drugs, biologics, and devices. Under 

section 502(a) of the act, a drug or 

device is misbranded if its labeling is 

false or misleading. Under section 

502(f)(1) of the act it is misbranded if it 

fails to bear adequate warnings, and 

under section 502(j), it is misbranded if 

it is dangerous to health when used as 

directed in its labeling. 

Under section 4 of the Dietary 

Supplement Health and Education Act 

of 1994 (the DSHEA) (21 U.S.C. 341), 

section 402 of the act (21 U.S.C 342) is 

amended so that FDA must bear the 

burden of proof to show a dietary 

supplement is unsafe. 

To carry out its responsibilities, the 

agency needs to be informed whenever 

an adverse event, product problem or 

error with use of a medication or device 

occurs. Only if FDA is provided with 

such information will the agency be able 

to evaluate the risk, if any, associated 

with the product, and take whatever 

action is necessary to reduce or 

eliminate the public’s exposure to the 

risk through regulatory action. To 

ensure the marketing of safe and 

effective products, certain adverse 

events must be reported. Requirements 

regarding mandatory reporting of 

adverse events or product problems 

have been codified in 21 CFR parts 310, 

314, 600, 803, and 1271, specifically 

§§ 310.305, 314.80, 314.98, 600.80, 

803.30, 803.50, 803.53, 803.56, and 

1271.350(a). 

Two forms are available from the 

agency to implement these provisions 

for reporting of adverse events, product 

problems, and medication/device use 

errors for FDA regulated products such 

as medications, devices, biologics, 

including human tissue, cell, tissue and 

cellular-based products, special 

nutritional products, and cosmetics, as 

well as any other products that are 

regulated by FDA. Form FDA 3500 may 

be used for voluntary (i.e., not mandated 

by law or regulation) reporting by 

healthcare professionals and the public. 

Form FDA 3500A is used for mandatory 

reporting (i.e., required by law or 

regulation). 

Respondents to this collection of 

information are healthcare 

professionals, hospitals and other user 

facilities (e.g., nursing homes, etc.), 

consumers, manufacturers of biological, 

drug, and dietary supplement products 

or medical devices, and importers. 

II. Use of Form FDA 3500 (Voluntary 

Version) 

The voluntary version of the form is 

used to submit all reports not mandated 

by Federal law or regulation. Individual 

health professionals are not required by 

law or regulation to submit reports to 

the agency or the manufacturer, with the 

exception of certain adverse reactions 

following immunization with vaccines 

as mandated by the National Childhood 

Vaccine Injury Act of 1986. Those 

mandatory reports are not submitted to 

FDA on the 3500 or 3500A form, but are 

submitted to the joint FDA/Centers for 

Disease Control and Prevention 

Vaccines Adverse Event Reporting 

System (VAERS) on the VAERS–1 form. 

(See http://www.vaers.hhs.gov/pdf/ 

vaers_form.pdf.) 

Hospitals are not required by Federal 

law or regulation to submit reports 

associated with drug products, 

biological products, or special 

nutritional products. However, hospitals 

and other user facilities are required by 

Federal law to report medical devicerelated deaths and serious injuries. The 

DSHEA puts the responsibility on FDA 

to prove that a particular product is 

unsafe. The agency depends on the 

voluntary reporting by health 

professionals and consumers of 

suspected adverse events associated 

with the use of dietary supplements. 

III. Use of Form FDA 3500A 

(Mandatory Version) 

A. Drug and Biologic Products 

In sections 505(j) (21 U.S.C. 355(j)) 

and 704 (21 U.S.C. 374) of the act, 

Congress has required that important 

safety information relating to all human 

prescription drug products be made 

available to FDA so that it can take 

appropriate action to protect the public 

health when necessary. Section 702 of 

the act (21 U.S.C. 372) authorizes 

investigational powers to FDA for 

enforcement of the act. These statutory 

requirements regarding mandatory 

reporting have been codified by FDA 

under parts 310 and 314 (drugs), 600 

(biologics) and 1271 (Human Cells, 

Tissues, and Cellular and Tissue-Based 

Products). Parts 310, 314, and 600 

mandate the use of FDA Form 3500A 

form for reporting to FDA on adverse 

events that occur with drugs and 

biologics. The Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act (Public Law 109–462, 

120 Stat. 3469) amended the act with 

respect to adverse event reporting and 

recordkeeping for dietary supplements 

and non-prescription drugs marketed 

without an approved application. The 

law provides for the mandatory 

reporting to FDA of serious adverse 

events for over-the-counter (OTC) drug 

products. The authority is 21 U.S.C. 

379aa-1(a)(3), (b)(1) and/or section 

761(a)(3) and (b)(1) of the act. 

B. Medical Device Products 

Section 519 of the act (21 U.S.C. 360i) 

requires manufacturers and importers of 

devices intended for human use to 

establish and maintain records, make 

reports, and provide information as the 

Secretary of Health and Human Services 

may, by regulation, reasonably require 

to assure that such devices are not 

adulterated or misbranded and to 

otherwise assure its safety and 

effectiveness. 

The Safe Medical Device Act of 1990, 

signed into law on November 28, 1990, 

amends section 519 of the act. The 

amendment requires that user facilities 

such as hospitals, nursing homes, 

ambulatory surgical facilities, and 

outpatient treatment facilities report 

deaths related to medical devices to 

FDA and to the manufacturer, if known. 

Serious illnesses and injuries are to be 

reported to the manufacturer or to FDA 

if the manufacturer is not known. These 

statutory requirements regarding 

mandatory reporting have been codified 

by FDA under part 803. Part 803 

mandates the use of FDA Form 3500A 

for reporting to FDA on medical 

devices. 

The Medical Device User Fee and 

Modernization Act of 2002 (MDUFMA) 

(Public Law 107–250) signed into law 

October 26, 2002, amended section 519 

of the act. The amendment (section 303 

of MDUFMA) required FDA to revise 

the MedWatch forms to facilitate the 

reporting of information relating to 

reprocessed single-use devices, 

including the name of the reprocessor 

and whether the device has been reused. 

C. Dietary Supplements 

The Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act amended the act with 

respect to adverse event reporting and 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 186 / Wednesday, September 24, 2008 / Notices 55113 

recordkeeping for dietary supplements 

and non-prescription drugs marketed 

without an approved application. The 

law provides for the mandatory 

reporting to the Food and Drug 

Administration of serious adverse 

events for dietary supplements. The 

authority is 21 U.S.C. 379aa-1(a)(3), 

(b)(1) and/or section 761(a)(3) and (b)(1) 

of the act. 

IV. Proposed Modifications to Forms 

FDA has proposed no modification to 

either the Form FDA 3500 or Form FDA 

3500A at this time. The requested 

extension for both forms will only result 

in changes in the form instructions 

rather than in any content or formatting 

for either form. The ability to change the 

instructions will allow for any and all 

necessary clarifications in the use of the 

form and can reflect the current range of 

reportable products (e.g., OTC products 

and dietary supplements). 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

FDA Center No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

CBER/CDER 

Form 3500 23,033 1 23,033 0.6 13,820 

Form 3500A (§§ 310.305, 314.80, 

314.98, and 600.80) 600 765 459,102 1.1 505,012 

CDRH 

Form 3500 4,375 1 4,375 0.6 2,625 

Form 3500A (Part 803) 

User 1,084 3 3,252 1.1 3,577 

Facilities 80 18 1,470 1.1 1,617 

Importers 2,946 48 141,405 1.1 155,545 

Manufacturers 160,739 

Total 3500A 163,364 

Total CDRH 

CFSAN 

Form 3500 479 1 479 0.6 287 

Form 3500A 0 0 0 1.1 0 

Form 3500 16,732 

Form 3500A 665,751 

Total 682,483 

1CBER (Center for Biologics Evaluation and Research), CDER (Center for Drug Evaluation and Research), CDRH (Center for Devices and Radiological Health), and CFSAN (Center for Food Safety and Applied Nutrition). Form FDA 3500 is for voluntary reporting. Form FDA 3500A is for 

mandatory reporting. There are no capital costs or operating and maintenance costs associated with this collection of information. (NOTE—The 

figures shown in table 1 of this document are based on actual calendar year 2007 reports and respondents. There is no burden calculation for 

the mandatory reporting requirements which went into effect on December 22, 2007, for dietary supplements (CFSAN) or OTC drugs (CDER). 

These estimates and opportunities for public comment will be addressed separately by FDA and will also be incorporated in subsequent requests 

for extension of Forms FDA 3500 and 3500A.) 

In the Federal Register of February 

15, 2008 (73 FR 8879), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. FDA received three 

comments. There were no comments 

submitted concerning the Form FDA 

3500, voluntary reporting form. All 

comments addressed Form FDA 3500A, 

the mandatory reporting form. There 

were no comments submitted 

concerning the mandatory 3500A form 

that addressed questions of whether the 

information obtained is necessary for 

the proper performance of FDA’s 

functions or comments about the 

practical utility of this information. 

There was one comment about the 

accuracy of the burden estimate for a 

subset of reports (dietary supplements). 

The remainder of the comments were 

specific suggestions for modifications of 

either the content or format of various 

fields to enhance clarity of information. 

There was also one comment about the 

use of information technology to 

support collection. 

One comment noted that there was no 

burden estimate offered for the 

mandatory reports that would be 

expected for serious adverse events 

associated with dietary supplement 

products. In addition, the comment 

offered an estimate of 30 minutes to 1 

hour for the time to complete, route for 

approval, and submit a mandatory 

report for a dietary supplement product. 

FDA agrees with this estimate and, for 

mandatory reports, has used a 1.1 hour 

estimate for time to complete a report. 

FDA has chosen to not attempt to 

estimate a reporting burden for 

mandatory dietary supplement report 

volume, because the burden estimate 

used in this request for extension of 

both reporting forms is based on actual 

reports for the calendar year 2007 and 

there was no requirement for 

submission of mandatory dietary 

supplement reports until December 22, 

2007. To address PRA burden estimates 

for mandatory reporting required for 

both dietary supplements and OTC 

products under the Dietary Supplement 

and Nonprescription Drug Consumer 

Protection Act of 2006, FDA will submit 

this burden estimate information under 

a separate Federal Register notice 

process. 

There were several comments 

suggesting a variety of changes in the 

formatting of certain fields in the 

mandatory form, changes to existing 

text, or addition of extra text. These 

changes were suggested to ‘‘reduce 

confusion and capture additional 

clarifying information.’’ For example, it 

was suggested that more space be 

allotted to certain fields to accept more 


jlentini on PROD1PC65 with NOTICES
55114 Federal Register / Vol. 73, No. 186 / Wednesday, September 24, 2008 / Notices 

text or that certain text fields be 

modified to ask supplemental questions 

of the reporter. 

FDA has carefully considered each of 

these changes but does not concur with 

making these elective changes, which 

are not based on any changes in law, 

rule, or regulation. Because FDA 

encourages electronic submission of 

postmarketing adverse event reports by 

mandatory reporters, and the majority of 

mandatory reporters use the paperbased Form FDA 3500A only for backup 

purposes, the agency believes that it 

would be an unfair burden to 

manufacturers who submit 

electronically to expend resources to 

change their electronic versions of the 

paper document which would be used 

only in times of rare network or server 

outages. FDA believes that each of these 

suggested elective text changes and 

additions can be addressed satisfactorily 

with specific clarifying information 

provided in the instructions section that 

supplements Form FDA 3500A. 

One comment suggests that FDA 

modify the forms to include wording as 

a ‘‘disclaimer by consumer authorizing 

the treating physician to speak with a 

manufacturer’s representative.’’ FDA 

disagrees with the inclusion of this type 

of information within the standard 

reporting form and believes that this 

type of information is best treated as 

part of other documentation maintained 

by the mandatory reporter. 

One comment suggests that provisions 

be made to allow for the inclusion of 

attachments with the serious adverse 

event report. FDA agrees and 

attachments are currently permitted 

both as supplements to mailed and 

faxed submissions. One comment 

acknowledged and supported the 

recently announced development of a 

unified federal approach to adverse 

event reporting, and suggested that this 

approach will ease the reporting burden 

for both industry and FDA and 

indirectly benefit consumers. 

The newly revised Forms FDA 3500 

and 3500A with updated instructions, 

which will address several comments’ 

concerns about clarity, will be made 

available, upon OMB approval, on the 

FDA’s MedWatch Web site at http:// 

www.fda.gov/medwatch/getforms.htm. 

Dated: September 18, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–22440 Filed 9–23–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0038] 

Endocrinologic and Metabolic Drugs 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). At least one portion of the 

meeting will be closed to the public. 

Name of Committee: Endocrinologic 

and Metabolic Drugs Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on October 21, 2008, from 8 a.m. 

to 5 p.m. 

Location: Crowne Plaza Hotel/ 

Washington DC–Silver Spring, The 

Ballrooms, 8777 Georgia Ave., Silver 

Spring, MD, 301–589–0800. 

Contact Person: Paul Tran, Center for 

Drug Evaluation and Research (HFD– 

21), Food and Drug Administration, 

5600 Fishers Lane (for express delivery, 

5630 Fishers Lane, rm. 1093) Rockville, 

MD 20857, 301–827–7001, FAX: 301– 

827–6776, e-mail: 

paul.tran@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512536. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: On October 21, 2008, the 

committee will begin with a closed 

session from 8 a.m. to 11 a.m. Following 

the closed session, from 11 a.m. to 5 

p.m., the meeting will be open to the 

public. The committee will discuss the 

safety and efficacy of biologic license 

application (BLA) 125291, MYOZYME 

(alglucosidase alfa), Genzyme Corp., for 

the treatment of late onset Pompe 

disease. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ohrms/ 

dockets/ac/acmenu.htm, click on the 

year 2008 and scroll down to the 

appropriate advisory committee link. 

Procedure: On October 21, 2008, from 

11 a.m. to 5 p.m., the meeting is open 

to the public. Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before October 7, 2008. 

Oral presentationsfrom the public will 

be scheduled between approximately 12 

noon and 1 p.m. Those desiring to make 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before September 29, 2008. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

September 30, 2008. 

Closed Committee Deliberations: On 

October 21, 2008, from 8 a.m. to 11 a.m., 

the meeting will be closed to permit 

discussion and review of trade secret 

and/or confidential information (5 

U.S.C. 552b(c)(4)). During this session, 

the committee will discuss the 

manufacturing as well as relevant 

biochemical and physiochemical 

attributes of alglucosidase alfa and how 

they impact clinical efficacy. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Paul Tran at 

least 7 days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 


jlentini on PROD1PC65 with NOTICES