81 FR 3438 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 13 (January 21, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 13 (January 21, 2016)
| Page Range | 3438-3439 | |
| FR Document | 2016-01103 |
[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)] [Notices] [Pages 3438-3439] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-01103] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0372] 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 February 22, 2016. 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 [email protected]. All comments should be identified with the OMB control number 0910-0635. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]. 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 (the 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 non-prescription 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 us 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 follow-up 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, we 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), we 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 follow-up reports. The guidance also provides our 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 their 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 3439]] 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 us with attachments; (3) any new information about the adverse event received by the responsible person; (4) any reports to us of new information related to the serious adverse event report. In the Federal Register of October 21, 2015 (80 FR 63797), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. We estimate 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 170 17 2,860 2 5,720 adverse event reports for dietary supplements............ 21 U.S.C. 379aa-1(c)(2)-- follow- 42 17 715 1 715 up reports of new medical information.................... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 6,435 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. This estimate is based on our experience with similar adverse event reporting programs and the number of serious adverse event reports and follow-up reports received in the past 3 years. All dietary supplement manufacturers, packers, or distributors are subject to serious adverse event mandatory reporting. We received 2,435 initial serious adverse event reports in Fiscal Year (FY) 2012, 3,414 in FY2013, and 2,745 in FY2014. We averaged these figures (2,860 rounded to the nearest ten) as a basis for our estimated number of annual reports. We also used an average of the number of firms filing reports (170 rounded to the nearest ten). Finally, we estimate 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 us on Form FDA 3500A. Thus, the estimated burden associated with submitting initial dietary supplement serious adverse event reports is 5,720 hours (2,860 responses x 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 us in a follow-up report. We estimate that 25 percent of serious adverse event reports related to dietary supplements will have a follow-up report submitted, resulting in approximately 715 follow-up reports submitted annually (2,860 x 0.25 = 715). Dividing the annual number of reports among the 170 firms reporting results in approximately 17 reports for 42 respondents. We estimate that each follow-up 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. Thus the estimated burden for follow-up reports of new information is 715 hours (715 responses x 1 hour) as shown in row 2 of table 1. Table 2--Estimated Annual Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average 21 U.S.C. Section Number of records per Total annual burden per Total hours recordkeepers recordkeeper records recordkeeping ---------------------------------------------------------------------------------------------------------------- Dietary supplement adverse event 1,700 74 125,800 0.5 62,900 records (21 U.S.C. 379aa- 1(e)(1))....................... ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. All dietary supplement manufacturers, packers, or distributors are subject to serious adverse event recordkeeping. We estimate that there are 1,700 such respondents, based on the figure 1,460 as provided in our final rule of June 25, 2007 (72 FR 34751), on the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, and factoring a two percent annual growth rate. Estimating that each recordkeeper will keep approximately 74 records per year results in an annual burden of 125,800 records. Estimating that assembling and filing these records, including any necessary photocopying, will take approximately 30 minutes, or 0.5 hours, per record, results in an annual burden of 62,900 hours (125,800 records x 0.50 hours = 62,900 total hours. Once the documents pertaining to an adverse event report have been assembled and filed pursuant to the Safety Reporting Portal, we expect the records retention burden to be minimal, as we believe 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: January 14, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-01103 Filed 1-20-16; 8:45 am] BILLING CODE 4164-01-P
![3438 Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices
document supersedes ‘‘Updated 510(k) DEPARTMENT OF HEALTH AND adverse event reporting and
Sterility Review Guidance K90–1’’ dated HUMAN SERVICES recordkeeping for dietary supplements
August 30, 2002. and non-prescription drugs marketed
Food and Drug Administration without an approved application.
II. Significance of Guidance Section 761(b)(1) of the FD&C Act (21
[Docket No. FDA–2007–D–0372]
This guidance is being issued U.S.C. 379aa–1(b)(1)) requires the
Agency Information Collection manufacturer, packer, or distributor
consistent with FDA’s good guidance
Activities; Submission for Office of whose name under section 403(e)(1) of
practices regulation (21 CFR 10.115).
Management and Budget Review; the FD&C Act (21 U.S.C. 343(e)(1)))
The guidance represents the current
Comment Request; Adverse Event appears on the label of a dietary
thinking of FDA on submission and supplement marketed in the United
review of sterility information in 510(k)s Reporting and Recordkeeping for
Dietary Supplements as Required by States to submit to us all serious adverse
for devices labeled as sterile. It does not event reports associated with the use of
establish any rights for any person and the Dietary Supplement and
Nonprescription Drug Consumer a dietary supplement, accompanied by a
is not binding on FDA or the public. copy of the product label. The
Protection Act
You can use an alternative approach if manufacturer, packer, or distributor of a
it satisfies the requirements of the AGENCY: Food and Drug Administration, dietary supplement is required by the
applicable statutes and regulations. HHS. DSNDCPA to use the MedWatch Form
ACTION: Notice. FDA 3500A when submitting a serious
III. Electronic Access
adverse event report to FDA. In
SUMMARY: The Food and Drug addition, under section 761(c)(2) of the
Persons interested in obtaining a copy
Administration (FDA) is announcing FD&C Act, the submitter of the serious
of the guidance may do so by that a proposed collection of
downloading an electronic copy from adverse event report (referred to in the
information has been submitted to the statute as the ‘‘responsible person’’) is
the Internet. A search capability for all Office of Management and Budget
Center for Devices and Radiological required to submit to FDA a follow-up
(OMB) for review and clearance under report of any related new medical
Health guidance documents is available the Paperwork Reduction Act of 1995.
at http://www.fda.gov/MedicalDevices/ information the responsible person
DATES: Fax written comments on the receives within 1 year of the initial
DeviceRegulationandGuidance/ collection of information by February report.
GuidanceDocuments/default.htm. 22, 2016. Section 761(e)(1) of the FD&C Act (21
Guidance documents are also available U.S.C. 379aa–1(e)(1)) requires that
ADDRESSES: To ensure that comments on
at http://www.fda.gov/BiologicsBlood the information collection are received, responsible persons maintain records
Vaccines/GuidanceCompliance OMB recommends that written related to the dietary supplement
RegulatoryInformation/Guidances/ comments be faxed to the Office of adverse event reports they receive,
default.htm or http:// Information and Regulatory Affairs, whether or not the adverse event is
www.regulations.gov. Persons unable to OMB, Attn: FDA Desk Officer, FAX: serious. Under the statute, the records
download an electronic copy of 202–395–7285, or emailed to oira_ must be retained for a period of 6 years.
‘‘Submission and Review of Sterility submission@omb.eop.gov. All As required by section 3(d)(3) of the
Information in Premarket Notification comments should be identified with the DSNDCPA, we issued guidance to
(510(k)) Submissions for Devices OMB control number 0910–0635. Also describe the minimum data elements for
Labeled as Sterile’’ may send an email include the FDA docket number found serious adverse event reports for dietary
request to CDRH-Guidance@fda.hhs.gov in brackets in the heading of this supplements. In the Federal Register of
to receive an electronic copy of the document. July 14, 2009 (74 FR 34024), we
document. Please use the document announced the availability of guidance
FOR FURTHER INFORMATION CONTACT: FDA
number 1615 to identify the guidance entitled ‘‘Guidance for Industry:
PRA Staff, Office of Operations, Food Questions and Answers Regarding
you are requesting. and Drug Administration, 8455 Adverse Event Reporting and
IV. Paperwork Reduction Act of 1995 Colesville Rd., COLE–14526, Silver Recordkeeping for Dietary Supplements
Spring, MD 20993–0002, PRAStaff@ as Required by the Dietary Supplement
This guidance refers to previously fda.hhs.gov. and Nonprescription Drug Consumer
approved collections of information SUPPLEMENTARY INFORMATION: In Protection Act’’. The guidance discusses
found in FDA regulations. These compliance with 44 U.S.C. 3507, FDA how, when, and where to submit serious
collections of information are subject to has submitted the following proposed adverse event reports for dietary
review by the Office of Management and collection of information to OMB for supplements and follow-up reports. The
Budget (OMB) under the Paperwork review and clearance. guidance also provides our
Reduction Act of 1995 (44 U.S.C. 3501– recommendation on records
3520). The collections of information in Adverse Event Reporting and maintenance and access for serious and
21 CFR part 807, subpart E, have been Recordkeeping for Dietary Supplements non-serious adverse event reports, and
approved under OMB control number as Required by the Dietary Supplement related documents.
0910–0120; and the collections of and Nonprescription Drug Consumer The guidance recommends that the
information in 21 CFR part 820 have Protection Act—21 U.S.C. 379aa–1(b)(1) responsible person document their
asabaliauskas on DSK9F6TC42PROD with NOTICES
been approved under OMB control OMB Control Number 0910–0635— attempts to obtain the minimum data
number 0910–0073. Extension elements for a serious adverse event
Dated: January 14, 2016. The Dietary Supplement and report. Along with these records, the
Nonprescription Drug Consumer guidance recommends that the
Leslie Kux,
Protection Act (the DSNDCPA) (Pub. L. responsible person keep the following
Associate Commissioner for Policy. 109–462, 120 Stat. 3469) amends the other records: (1) Communications
[FR Doc. 2016–01093 Filed 1–20–16; 8:45 am] Federal Food, Drug, and Cosmetic Act between the responsible person and the
BILLING CODE 4164–01–P (the FD&C Act) with respect to serious initial reporter of the adverse event and
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![Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices 3439
between the responsible person and any event received by the responsible 60-day notice requesting public
other person(s) who provided person; (4) any reports to us of new comment on the proposed collection of
information about the adverse event; (2) information related to the serious information. No comments were
the responsible person’s serious adverse adverse event report. received.
event report to us with attachments; (3) In the Federal Register of October 21, We estimate the burden of this
any new information about the adverse 2015 (80 FR 63797), FDA published a collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number Total annual
21 U.S.C. Section responses per burden per Total hours
of respondents responses
respondent response
21 U.S.C. 379aa–1(b)(1)—serious adverse event reports
for dietary supplements .................................................... 170 17 2,860 2 5,720
21 U.S.C. 379aa–1(c)(2)— follow-up reports of new med-
ical information ................................................................. 42 17 715 1 715
Total .............................................................................. ........................ ........................ ........................ ........................ 6,435
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
This estimate is based on our respondents an average of 2 hours per adverse event reports related to dietary
experience with similar adverse event report to collect information about a supplements will have a follow-up
reporting programs and the number of serious adverse event associated with a report submitted, resulting in
serious adverse event reports and dietary supplement and report the approximately 715 follow-up reports
follow-up reports received in the past 3 information to us on Form FDA 3500A. submitted annually (2,860 × 0.25 = 715).
years. All dietary supplement Thus, the estimated burden associated Dividing the annual number of reports
manufacturers, packers, or distributors with submitting initial dietary among the 170 firms reporting results in
are subject to serious adverse event supplement serious adverse event approximately 17 reports for 42
mandatory reporting. reports is 5,720 hours (2,860 responses respondents. We estimate that each
We received 2,435 initial serious × 2 hours) as shown in row 1 of table
follow-up report will require an hour to
adverse event reports in Fiscal Year (FY) 1.
2012, 3,414 in FY2013, and 2,745 in If a respondent that has submitted a assemble and submit, including the time
FY2014. We averaged these figures serious adverse event report receives needed to copy and attach the initial
(2,860 rounded to the nearest ten) as a new information related to the serious serious adverse event report as
basis for our estimated number of adverse event within 1 year of recommended in the guidance. Thus the
annual reports. We also used an average submitting the initial report, the estimated burden for follow-up reports
of the number of firms filing reports respondent must provide the new of new information is 715 hours (715
(170 rounded to the nearest ten). information to us in a follow-up report. responses × 1 hour) as shown in row 2
Finally, we estimate that it will take We estimate that 25 percent of serious of table 1.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
21 U.S.C. Section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
Dietary supplement adverse event records (21 U.S.C.
379aa–1(e)(1)) .................................................................. 1,700 74 125,800 0.5 62,900
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
All dietary supplement necessary photocopying, will take Dated: January 14, 2016.
manufacturers, packers, or distributors approximately 30 minutes, or 0.5 hours, Leslie Kux,
are subject to serious adverse event per record, results in an annual burden Associate Commissioner for Policy.
recordkeeping. We estimate that there of 62,900 hours (125,800 records × 0.50 [FR Doc. 2016–01103 Filed 1–20–16; 8:45 am]
are 1,700 such respondents, based on hours = 62,900 total hours. BILLING CODE 4164–01–P
the figure 1,460 as provided in our final Once the documents pertaining to an
rule of June 25, 2007 (72 FR 34751), on adverse event report have been
the Current Good Manufacturing assembled and filed pursuant to the
Practice in Manufacturing, Packaging, Safety Reporting Portal, we expect the
asabaliauskas on DSK9F6TC42PROD with NOTICES
Labeling, or Holding Operations for records retention burden to be minimal,
Dietary Supplements, and factoring a as we believe most establishments
two percent annual growth rate. would normally keep this kind of record
Estimating that each recordkeeper will for at least several years after receiving
keep approximately 74 records per year the report, as a matter of usual and
results in an annual burden of 125,800 customary business practice.
records. Estimating that assembling and
filing these records, including any
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Document Created: 2018-02-02 12:33:59
Document Modified: 2018-02-02 12:33:59
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by February 22, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 3438 |
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