17076 Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0274] 

Agency Information Collection 

Activities; Proposed Collection; 

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 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 

the collection of information associated 

with adverse event reporting and 

recordkeeping for dietary supplements 

as required by the Dietary Supplement 

and Nonprescription Drug Consumer 

Protection Act (the DSNDCPA). 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 22, 2012. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. 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: 

Denver Presley, II, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793, Denver.Presley@fda.hhs.gov. 

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. 

Adverse Event Reporting and 

Recordkeeping for Dietary Supplements 

as Required by the Dietary Supplement 

and Nonprescription Drug Consumer 

Protection Act —21 U.S.C. 379aa– 

1(b)(1) (OMB Control Number 0910– 

0635)—Extension 

The DSNDCPA (Public Law 109–462, 

120 Stat. 3469) amends the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) with respect to serious 

adverse event reporting and 

recordkeeping for dietary supplements 

and nonprescription drugs marketed 

without an approved application. 

Section 761(b)(1) of the FD&C Act (21 

U.S.C. 379aa–1(b)(1)) requires the 

manufacturer, packer, or distributor 

whose name (under section 403(e)(1) of 

the FD&C Act (21 U.S.C. 343(e)(1))) 

appears on the label of a dietary 

supplement marketed in the United 

States to submit to FDA all serious 

adverse event reports associated with 

the use of a dietary supplement, 

accompanied by a copy of the product 

label. The manufacturer, packer, or 

distributor of a dietary supplement is 

required by the DSNDCPA to use the 

MedWatch form (FDA 3500A) when 

submitting a serious adverse event 

report to FDA. In addition, under 

section 761(c)(2) of the FD&C 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. 

Section 761(e)(1) of the FD&C Act (21 

U.S.C. 379aa–1(e)(1)) requires that 

responsible persons maintain records 

related to the 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. 

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

DSNDCPA, FDA issued guidance to 

describe the minimum data elements for 

serious adverse event reports for dietary 

supplements. In the Federal Register of 

July 14, 2009 (74 FR 34024), FDA 

announced the availability of guidance 

entitled ‘‘Guidance for Industry: 

Questions and Answers Regarding 

Adverse Event Reporting and 

Recordkeeping for Dietary Supplements 

as Required by the Dietary Supplement 

and Nonprescription Drug Consumer 

Protection Act.’’ The guidance discusses 

how, when, and where to submit serious 

adverse event reports for dietary 

supplements and followup reports. The 

guidance also provides FDA’s 

recommendation on records 

maintenance and access for serious and 

non-serious adverse event reports and 

related documents. 

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 

between the responsible person and any 

other person(s) who provided 

information about the adverse event, (2) 

the responsible person’s serious adverse 

event report to FDA with attachments, 

(3) any new information about the 

adverse event received by the 

responsible person, and (4) any reports 

to FDA of new information related to 

the serious adverse event report. 

FDA estimates the burden of this 

collection of information as follows: 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Notices 17077 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 U.S.C. Section Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total 

hours 

21 U.S.C. 379aa–1(b)(1)—Serious adverse event reports 

for dietary supplements .................................................... 480 17 8,160 2 16,320 

21 U.S.C. 379aa–1(c)(2)—Followup reports of new medical information ................................................................. 120 17 2,040 1 2,040 

18,360 

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

This estimate is based on FDA’s 

experience with similar adverse event 

reporting programs and the number of 

serious adverse event reports and 

followup reports received in the past 2 

years. All dietary supplement 

manufacturers, packers, or distributors 

are subject to serious adverse event 

mandatory reporting. In 2007, we 

estimated in the final rule entitled 

‘‘Current Good Manufacturing Practice 

in Manufacturing, Packaging, Labeling, 

or Holding Operations for Dietary 

Supplements’’ (72 FR 34752, June 25, 

2007) that there were 1,460 such firms. 

FDA estimates that, in 2012, there are 

approximately 1,600 such firms, based 

on the estimate of 1,460 provided in the 

rule, with a two to three percent annual 

rate of growth applied. 

FDA received 830 initial serious 

adverse event reports in FY2010. The 

number of reports more than doubled to 

1,777 in FY2011. We expect this trend 

to continue and, in fact, increase due to 

continued industry compliance with 

mandatory reporting rules. Based on 

this, FDA expects to receive over the 

next 3 years an increasing number of 

reports per year: We estimate that we 

will receive 3,500 in 2012; 7,000 in 

2013; and 14,000 in 2014; for an annual 

average of 8,166.66 per year, rounded to 

8,160. Based on the Agency’s records, 

the average number of initial reports per 

year on a per firm basis during 2010 and 

2011 was 17. Thus, FDA estimates that, 

on average over the next 3 years, 480 

firms will file 17 initial dietary 

supplement serious adverse event 

reports, for a total of 8,160 total annual 

responses. 

FDA estimates that it will take 

respondents an average of 2 hours per 

report to collect information about a 

serious adverse event associated with a 

dietary supplement and report the 

information to FDA on Form FDA 

3500A. Thus, the estimated total annual 

hour burden of initial dietary 

supplement serious adverse event 

reports is 16,320 hours (8,160 responses 

× 2 hours) as shown in row 1 of Table 

1. 

If a respondent that has submitted a 

serious adverse event report receives 

new information related to the serious 

adverse event within 1 year of 

submitting the initial report, the 

respondent must provide the new 

information to FDA in a followup 

report. FDA estimates that 25 percent of 

serious adverse event reports related to 

dietary supplements will have a 

followup report submitted, resulting in 

approximately 2,040 followup reports 

submitted annually (8,160 × 0.25 = 

2,040). Assuming that 25 percent of 

submitters of initial reports will submit 

followup reports (480 × 0.25 = 120) and 

the average number of followup reports 

per year per firm to be 17, FDA 

estimates that, on average over the next 

3 years, 120 firms will file 17 followup 

reports, for a total of 2,040 total annual 

responses. We estimate that each 

followup report will require an hour to 

assemble and submit, including the time 

needed to copy and attach the initial 

serious adverse event report as 

recommended in the guidance. The 

estimated total annual hour burden for 

followup reports of new information is 

2,040 hours (2,040 responses × 1 hour) 

as shown in row 2 of Table 1. 

The total reporting hour burden is 

18,360 hours, which equals the burden 

for the mandatory reports (16,320) plus 

the burden for the followup new 

information (2,040). 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 U.S.C. Section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total 

annual 

records 

Average 

burden per 

recordkeeping 

Total 

hours 

Dietary Supplement Adverse Event Records (21 U.S.C. 

379aa–1(e)(1)).

1,600 74 118,400 0.5 (30 minutes).59,200 

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

All 1,600 dietary supplement 

manufacturers, packers, or distributors, 

are subject to serious adverse event 

mandatory recordkeeping, thus FDA 

estimates that there are a total of 1,600 

recordkeepers. FDA further estimates 

that each recordkeeper will keep 

approximately 74 records per year, for a 

total of 118,400 records. The Agency 

estimates that assembling and filing 

these records, including any necessary 

photocopying, will take approximately 

30 minutes, or 0.5 hours, per record. 

Therefore, 118,400 records × 0.50 hours 

= 59,200 total hours. FDA bases its 

estimates on its experience with similar 

adverse event reporting programs. 

Once the documents pertaining to an 

adverse event report have been 

assembled and filed under the Safety 

Reporting Portal, 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. 

Dated: March 19, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6961 Filed 3–22–12; 8:45 am] 

BILLING CODE 4160–01–P 


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