[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]
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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.
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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
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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\
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Number of Average
21 U.S.C. Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
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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....................
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Total....................... .............. .............. .............. .............. 18,360
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\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\
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Number of Average burden
21 U.S.C. Section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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(21 U.S.C. 379aa-1(e)(1))-- 1,600 74 118,400 \2\ 0.5 59,200
Dietary supplement adverse
event records..................
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\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
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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