53252 Federal Register / Vol. 73, No. 179 / Monday, September 15, 2008 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

No. of 

Respondents 

Annual 

Frequency per 

Response 

Total Annual 

Responses 

Hours Per 

Response Total Hours 

Reports of serious adverse drug events (21 

U.S.C. 379aa((b) and (c)) 50 250 12,500 2 25,000 

Total 25,000 

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

The guidance also recommends that 

responsible persons maintain records of 

efforts to obtain the minimum data 

elements for a report of a serious 

adverse drug event and any followup 

reports. Although the guidance 

document does not provide 

recommendations on all the 

recordkeeping activities required under 

section 760(e) of the act, we are 

providing an estimate for this burden. 

Historically, serious adverse event 

reports comprise approximately twothirds, and nonserious adverse event 

reports comprise approximately onethird, of the total number of 

postmarketing adverse event reports 

associated with drugs and biologic 

therapeutics (except vaccines) received 

by FDA. Based on this generalization, 

we estimate the total annual records to 

be approximately 20,000 records per 

year, and the number of respondents to 

be approximately 200. We also estimate 

that it takes approximately 5 hours to 

maintain each record. 

TABLE 2.— ESTIMATED ANNUAL RECORDKEEPING BURDEN1

No. of 

Recordkeepers 

Annual 

Frequency per 

Recordkeeping 

Total Annual 

Records 

Hours Per 

Record Total Hours 

Recordkeeping (21 U.S.C. 379aa(e)(1)) 200 100 20,000 5 100,000 

Total 100,000 

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

Therefore, the estimated annual 

reporting burden for this information 

collection is 25,000 hours and the 

estimated annual recordkeeping burden 

is 100,000 hours. 

Dated: September 8, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–21345 Filed 9–12–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0372] (formerly 

Docket No. 2007D–0388) 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Adverse Event 

Reporting and Recordkeeping for 

Dietary Supplements as Required by 

the Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act 

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. 

DATES: Fax written comments on the 

collection of information by October 15, 

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–NEW and title, 

‘‘Adverse Event Reporting and 

Recordkeeping for Dietary Supplements 

as Required by the Dietary Supplement 

and Nonprescription Drug Consumer 

Protection Act.’’ Also include the FDA 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

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. 

Adverse Event Reporting and 

Recordkeeping for Dietary Supplements 

as Required by the Dietary Supplement 

and Nonprescription Drug Consumer 

Protection Act—(OMB Control Number 

0910–NEW) 

Description of Respondents: 

Respondents to this collection of 

information are manufacturers, packers, 

and distributors of dietary supplements 

marketed in the United States. 

On December 22, 2006, the President 

signed into law the Dietary Supplement 

and Nonprescription Drug Consumer 

Protection Act (DSNDCPA) (Public Law 

109–462, 120 Stat. 3469). This law 

amends the Federal Food, Drug, and 

Cosmetic Act (the act) with respect to 

serious adverse event reporting and 

recordkeeping for dietary supplements 

and non-prescription drugs marketed 

without an approved application. 

Under section 761(b)(1) of the act (21 

U.S.C. 379aa–1(b)(1)), the manufacturer, 

packer, or distributor whose name 

(under section 403(e)(1) of the act (21 

U.S.C. 343(e)(1))) appears on the label of 

a dietary supplement marketed in the 

United States is required to submit to 

FDA any serious adverse event report it 

receives regarding use of the dietary 

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Federal Register / Vol. 73, No. 179 / Monday, September 15, 2008 / Notices 53253 

supplement in the United States, 

accompanied by a copy of the product 

label. In addition, under section 

761(c)(2) of the act, the submitter of the 

serious adverse event report (referred to 

in the statute as the ‘‘responsible 

person’’) is required to submit to FDA 

a followup report of any related new 

medical information the responsible 

person receives within 1 year of the 

initial report. Under section 761(e)(1) of 

the act, responsible persons are required 

to maintain records related to dietary 

supplement adverse event reports they 

receive, whether or not the adverse 

event is serious. These requirements 

became effective on December 22, 2007. 

As required by section 3(d)(3) of the 

DSNDCPA, FDA is issuing guidance to 

describe the minimum data elements for 

serious adverse event reports for dietary 

supplements. The draft guidance 

entitled ‘‘Questions and Answers 

Regarding Adverse Event Reporting and 

Recordkeeping for Dietary Supplements 

as Required by the Dietary Supplement 

and Nonprescription Drug Consumer 

Protection Act,’’ was issued October 15, 

2007, and is consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance discusses 

how, when, and where to submit serious 

adverse event reports for dietary 

supplements and followup reports of 

new medical information. In accordance 

with the statutory requirements that 

serious adverse event reports for dietary 

supplements be submitted via 

MedWatch (section 761(d) of the act) 

and that FDA consolidate all 

information related to a serious adverse 

event into a single report (section 

761(c)(3) of the act), the draft guidance 

directs the responsible person to submit 

serious adverse event reports on 

MedWatch Form 3500A and to attach a 

copy of the initial serious adverse event 

report on Form 3500A as part of any 

followup report of new medical 

information. We are also providing 

guidance on records maintenance and 

access for serious and non-serious 

adverse event reports and related 

documents. 

In the Federal Register of October 15, 

2007 (72 FR 58313), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. FDA received one comment 

related to the information collection. 

The comment disagreed with FDA’s 

proposed estimate of the annual 

recordkeeping burden associated with 

dietary supplement adverse events. 

However, the commenter did not 

provide an alternative estimate or 

compelling information that the 

estimate provided by FDA was not a 

reasonable upper-bound estimate. Since 

the receipt of the comment, the 

mandatory reporting of serious adverse 

events for dietary supplements to FDA 

has come into effect (on December 22, 

2007). Thus, FDA now has data on 

mandatory dietary supplement adverse 

event reports to use in revising our 

reporting burden estimate. For the first 

quarter of 2008 (January 1 to April 15), 

FDA has received 214 mandatory 

reports of serious adverse events related 

to dietary supplements. Therefore, FDA 

revises our annual burden estimate from 

960 mandatory reports to 856 

mandatory reports of serious adverse 

events related to dietary supplements. 

FDA requests comments on this 

estimate. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Serious adverse event reports for 

dietary supplements (21 U.S.C. 

379aa–1(b)(1)) 71 .3333 12 856 2 1,712 

Followup reports of new medical information (21 U.S.C. 379aa– 

1(c)(2)) 17 .83333 12 214 1 214 

Total 1,926 

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

FDA’s Center for Drug Evaluation and 

Research estimates it will take 

respondents a total of 2 hours to collect 

information about a serious adverse 

event associated with an over-thecounter drug marketed without an 

approved application and report the 

information to FDA on MedWatch Form 

3500A. That time burden estimate is 

based on FDA’s knowledge of the 

adverse drug experience reports 

submitted to the agency for 

nonprescription drug products marketed 

under an approved application, 

including knowledge about the time 

needed to prepare the reports. FDA 

believes that the time for a dietary 

supplement firm to collect information 

about a serious adverse event associated 

with a dietary supplement and report 

the information to FDA will be 

approximately the same, as MedWatch 

Form 3500A will be used in both cases; 

therefore, we also estimate this time 

burden at 2 hours per report. The 

estimated total annual burden for 

dietary supplement serious adverse 

event reports is shown in row 1 of table 

1 of this document. 

If a firm that has submitted a serious 

adverse event report receives new 

medical information related to the 

serious adverse event within 1 year of 

submitting the initial report, the firm 

must provide the new medical 

information to FDA in a followup 

report. Given our limited experience 

with mandatory dietary supplement 

adverse event reporting, we do not have 

any information on the number of 

followup reports of new medical 

information that will be submitted to 

FDA each year. We expect followup 

medical information to be reported for 

some percentage of the 856 serious 

adverse event reports we estimate 

receiving annually. In the absence of 

data that would support a more precise 

estimate, we will assume that 25 percent 

of the 856 serious adverse event reports 

for dietary supplements will have a 

followup report submitted. FDA 

requests comments on this estimate. We 

estimate that each followup report will 

require 1 hour to assemble and submit, 

including the time needed to copy and 

attach the initial serious adverse event 

report as recommended in the draft 

guidance. We assume the followup 

report will take less time than the initial 

serious adverse event report, as the 

responsible person will not need to fill 

out Form 3500A for the followup report. 

FDA requests comments on whether the 

burden estimate of 1 hour is reasonable 

for this information collection. The 

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53254 Federal Register / Vol. 73, No. 179 / Monday, September 15, 2008 / Notices 

estimated total annual burden for 

followup reports of new medical 

information is shown in row 2 of table 

1 of this document. 

As previously noted, section 761(e)(1) 

of the act requires that responsible 

persons maintain records related to 

dietary supplement adverse event 

reports they receive, whether or not the 

adverse event is serious. Under the 

statute, the records must be retained for 

a period of 6 years. The draft guidance 

provides FDA’s recommendations as to 

what records industry should maintain 

to satisfy the statutory recordkeeping 

requirement. 

The guidance recommends that the 

responsible person document its 

attempts to obtain the minimum data 

elements for a serious adverse event 

report. Along with these records, the 

guidance recommends that the 

responsible person keep the following 

other records: (1) Communications 

between the responsible person and the 

initial reporter of the adverse event and 

with any other person(s) who provided 

information about the adverse event; (2) 

(for serious adverse events only) the 

responsible person’s serious adverse 

event report to FDA on MedWatch Form 

3500A, with attachments; (3) any new 

medical information about the adverse 

event received by the responsible 

person; (4) (for serious adverse events 

only) any reports to FDA of new 

medical information related to the 

serious adverse event report. We 

estimate that assembling and filing these 

records, including any necessary 

photocopying, will take approximately 

0.5 hours per adverse event report 

received by the responsible person. 

Once the documents pertaining to an 

adverse event report have been 

assembled and filed, FDA expects the 

records retention burden to be minimal, 

as the agency believes most 

establishments would normally keep 

this kind of record for at least several 

years after receiving the report, as a 

matter of usual and customary business 

practice. FDA requests comment on 

current adverse event recordkeeping 

practices in the dietary supplement 

industry, including the length of time 

such records are typically kept. 

According to a 2001 report by the 

Office of the Inspector General, between 

1994–1999 FDA received 2,547 adverse 

event reports involving dietary 

supplements, or about 500 reports per 

year, on average. According to the 

report, the actual number of adverse 

events relating to dietary supplements is 

likely to be at least 100 times that many, 

or more than 50,000 adverse events per 

year. Given that we have limited data on 

how many adverse events will be 

reported each year to the responsible 

person, we are using the 50,000 per year 

figure as an upper-bound estimate of 

reporting. This is almost certainly an 

overestimate of the number of reports 

the firms will receive, as it is unlikely 

that every adverse event that occurs will 

be reported to the responsible person. 

FDA requests comments on this 

estimate. 

We estimated in the economic impact 

analysis of the Dietary Supplement 

Good Manufacturing Practices final rule 

(the GMP final rule) (72 FR 34752, June 

25, 2007) that there are 1,460 

manufacturers, packers, and holders of 

dietary supplements (72 FR 34752 at 

34920). We assume that the estimated 

50,000 adverse event reports related to 

dietary supplements will be spread 

evenly among these firms. The estimate 

of the number of manufacturers, 

packers, and holders of dietary 

supplements from the GMP final rule is 

FDA’s best estimate of the number of 

firms that are ‘‘responsible persons’’ 

who must comply with the 

recordkeeping requirements of the 

DSNDCPA; however, it is not a precise 

estimate because the number of dietary 

supplement establishments covered by 

the GMP final rule is likely to be larger 

than the number of ‘‘responsible 

persons,’’ where a ‘‘responsible person’’ 

is a dietary supplement manufacturer, 

packer, or distributor whose name is 

listed on the label of a dietary 

supplement marketed in the United 

States (see section 761(b)(1) of the act). 

Thus, FDA’s estimate for the number of 

respondents in table 2 may be over 

inclusive. FDA requests comments on 

the number of firms that would be 

subject to the recordkeeping 

requirements of the DSNDCPA. 

The estimated total annual 

recordkeeping burden under the statute 

and this guidance is shown in table 2 of 

this document. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records2

Hours per 

Record Total Hours 

Dietary supplement adverse event 

records (21 U.S.C. 379aa– 

1(e)(1)) 1,460 4.2465 50,000 0.5 25,000 

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

2For purposes of estimating the number of records and hours per record, a ‘‘record’’ means all records kept for an individual adverse event report received by the responsible person. 

Dated: September 8, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–21454 Filed 9–12–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0480] 

Animal Drug User Fee Rates and 

Payment Procedures for Fiscal Year 

2009 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

rates and payment procedures for fiscal 

year (FY) 2009 for user fees under the 

Animal Drug User Fee Act program 

(ADUFA). The Federal Food, Drug, and 

Cosmetic Act (the act), as amended by 

the Animal Drug User Fee Act of 2003 

(ADUFA I), and the Animal Drug User 

Fee Amendments of 2008 (ADUFA II), 

authorizes FDA to collect user fees for 

certain animal drug applications, on 

certain animal drug products, on certain 

establishments where such products are 

made, and on certain sponsors of such 

animal drug applications and/or 

investigational animal drug 

mstockstill on PROD1PC66 with NOTICES