Document ID: FDA-2012-N-0274-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Adverse Event Reporting and Recordkeeping for Dietary Supplements
Posted Date: 2012-05-29T04:00Z

[Federal Register Volume 77, Number 103 (Tuesday, May 29, 2012)]
[Notices]
[Pages 31622-31624]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12878]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0274]

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 June 
28, 2012.

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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0428. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T, 
Rockville, MD 20850, 301-796-5733, domini.bean@fda.hhs.gov.

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--21 U.S.C. 379aa-1(b)(1) (OMB Control Number 0910-
0635)--Extension

    The Dietary Supplement and Nonprescription Drug Consumer Protection 
Act (DSNDCPA) (Pub. L. 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 the 
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

[[Page 31623]]

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:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
        21 U.S.C. Section            Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
21 U.S.C. 379aa-1(b)(1)--Serious             480              17           8,160               2          16,320
 adverse event reports for
 dietary supplements............
21 U.S.C. 379aa-1(c)(2)--                    120              17           2,040               1           2,040
 Followup reports of new medical
 information....................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          18,360
----------------------------------------------------------------------------------------------------------------
\1\ There 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 2 to 
3 percent annual rate of growth applied.
    FDA received 830 initial serious adverse event reports in FY 2010. 
The number of reports more than doubled to 1,777 in FY 2011. 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 x 2 hours) as shown in row 1 of table 1 in this 
document.
    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 x 0.25 = 2,040). Assuming 
that 25 percent of submitters of initial reports will submit followup 
reports (480 x 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 x 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 Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
        21 U.S.C. Section            Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
(21 U.S.C. 379aa-1(e)(1))--                1,600              74         118,400         \2\ 0.5          59,200
 Dietary supplement adverse
 event records..................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ 30 minutes.

    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 x 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

[[Page 31624]]

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: May 22, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-12878 Filed 5-25-12; 8:45 am]
BILLING CODE 4160-01-P