83 FR 15153 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 68 (April 9, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 68 (April 9, 2018)
| Page Range | 15153-15154 | |
| FR Document | 2018-07154 |
[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)] [Notices] [Pages 15153-15154] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-07154] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0610] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic 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 May 9, 2018. 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 0910-0701. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [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. Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic OMB Control Number 0910-0701--Extension This information collection supports the above captioned Agency guidance. The guidance includes recommendations for planning, notification, and documentation for firms that report postmarketing adverse events. The guidance recommends that each firm's pandemic influenza continuity of operations plan (COOP) include instructions for reporting adverse events, including a plan for the submission of stored reports that were not submitted within regulatory timeframes. The guidance explains that firms that are unable to fulfill normal adverse event reporting requirements during an influenza pandemic should: (1) Maintain documentation of the conditions that prevent them from meeting normal reporting requirements; (2) notify the appropriate FDA organizational unit responsible for adverse event reporting compliance when the conditions exist and when the reporting process is restored; and (3) maintain records to identify what reports have been stored. Based on the number of manufacturers that would be covered by the guidance, we estimate that approximately 5,000 firms will add the following to their COOP: (1) Instructions for reporting adverse events and (2) a plan for submitting stored reports that were not submitted within regulatory timeframes. We estimate that each firm will take approximately 50 hours to prepare the adverse event reporting plan for its COOP. We estimate that approximately 500 firms will be unable to fulfill normal adverse event reporting requirements because of conditions caused by an influenza pandemic and that these firms will notify the appropriate FDA organizational unit responsible for adverse event reporting compliance when the conditions exist. Although we do not anticipate such pandemic influenza conditions to occur every year, for purposes of the PRA, we estimate that each of these firms will notify FDA approximately once each year and that each notification will take approximately 8 hours to prepare and submit. Concerning the recommendation in the guidance that firms unable to fulfill normal adverse event reporting requirements maintain documentation of the conditions that prevent them from meeting these requirements and also maintain records to identify what adverse event reports have been stored and when the reporting process is restored, we estimate that approximately 500 firms will each need approximately 8 hours to maintain the documentation and that approximately 500 firms will each need approximately 8 hours to maintain the records. In the Federal Register of October 31, 2017 (82 FR 50431) we published a notice inviting public comment of the proposed collection of information. Although one comment was received, it did not respond to any of the four information collection topics solicited in the notice under the PRA. We therefore made no changes to our estimate of the burden for the information collection, which remains as follows: [[Page 15154]] Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Type of reporting Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- Notify FDA when normal reporting is not feasible................... 500 1 500 8 4,000 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2--Estimated Annual Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Type of recordkeeping Number of records per Total annual Hours per Total hours recordkeepers recordkeeper records record ---------------------------------------------------------------------------------------------------------------- Add adverse event reporting 5,000 1 5,000 50 250,000 plan to COOP.................. Maintain documentation of 500 1 500 8 4,000 influenza pandemic conditions and resultant high absenteeism Maintain records to identify 500 1 500 8 4,000 what reports have been stored and when the reporting process was restored.................. -------------------------------------------------------------------------------- Total...................... ............... .............. .............. .............. 258,000 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: April 3, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-07154 Filed 4-6-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices 15153
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB—Continued
Date
OMB
Title of collection approval
Control No. expires
Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Pro-
motion ................................................................................................................................................................... 0910–0849 1/31/2021
Data to Support Drug Product Communications ..................................................................................................... 0910–0695 2/28/2021
Applications for FDA Approval to Market a New Drug ........................................................................................... 0910–0001 3/31/2021
Animal Drug Adverse Event Reporting and Recordkeeping ................................................................................... 0910–0284 3/31/2021
Extralabel Drug Use in Animals .............................................................................................................................. 0910–0325 3/31/2021
Application for Participation in FDA Fellowship Programs ...................................................................................... 0910–0780 3/31/2021
Dated: April 3, 2018. Food and Drug Administration, Three plan for submitting stored reports that
Leslie Kux, White Flint North, 10A–12M, 11601 were not submitted within regulatory
Associate Commissioner for Policy. Landsdown St., North Bethesda, MD timeframes. We estimate that each firm
[FR Doc. 2018–07146 Filed 4–6–18; 8:45 am] 20852, 301–796–5733, PRAStaff@ will take approximately 50 hours to
BILLING CODE 4164–01–P
fda.hhs.gov. prepare the adverse event reporting plan
SUPPLEMENTARY INFORMATION: In for its COOP.
compliance with 44 U.S.C. 3507, FDA We estimate that approximately 500
DEPARTMENT OF HEALTH AND has submitted the following proposed firms will be unable to fulfill normal
HUMAN SERVICES collection of information to OMB for adverse event reporting requirements
review and clearance. because of conditions caused by an
Food and Drug Administration
Guidance for Industry on influenza pandemic and that these firms
[Docket No. FDA–2008–D–0610] Postmarketing Adverse Event Reporting will notify the appropriate FDA
for Medical Products and Dietary organizational unit responsible for
Agency Information Collection adverse event reporting compliance
Supplements During an Influenza
Activities; Submission for Office of when the conditions exist. Although we
Pandemic
Management and Budget Review; do not anticipate such pandemic
Comment Request; Guidance for OMB Control Number 0910–0701— influenza conditions to occur every
Industry on Postmarketing Adverse Extension year, for purposes of the PRA, we
Event Reporting for Medical Products This information collection supports estimate that each of these firms will
and Dietary Supplements During an the above captioned Agency guidance. notify FDA approximately once each
Influenza Pandemic The guidance includes year and that each notification will take
AGENCY: Food and Drug Administration, recommendations for planning, approximately 8 hours to prepare and
HHS. notification, and documentation for submit.
ACTION: Notice. firms that report postmarketing adverse Concerning the recommendation in
events. The guidance recommends that the guidance that firms unable to fulfill
SUMMARY: The Food and Drug each firm’s pandemic influenza
normal adverse event reporting
Administration (FDA) is announcing continuity of operations plan (COOP)
requirements maintain documentation
that a proposed collection of include instructions for reporting
of the conditions that prevent them from
information has been submitted to the adverse events, including a plan for the
meeting these requirements and also
Office of Management and Budget submission of stored reports that were
maintain records to identify what
(OMB) for review and clearance under not submitted within regulatory
timeframes. The guidance explains that adverse event reports have been stored
the Paperwork Reduction Act of 1995. and when the reporting process is
DATES: Fax written comments on the firms that are unable to fulfill normal
adverse event reporting requirements restored, we estimate that
collection of information by May 9, approximately 500 firms will each need
2018. during an influenza pandemic should:
(1) Maintain documentation of the approximately 8 hours to maintain the
ADDRESSES: To ensure that comments on
conditions that prevent them from documentation and that approximately
the information collection are received, meeting normal reporting requirements; 500 firms will each need approximately
OMB recommends that written (2) notify the appropriate FDA 8 hours to maintain the records.
comments be faxed to the Office of organizational unit responsible for In the Federal Register of October 31,
Information and Regulatory Affairs, adverse event reporting compliance 2017 (82 FR 50431) we published a
OMB, Attn: FDA Desk Officer, Fax: 202– when the conditions exist and when the notice inviting public comment of the
395–7285, or emailed to oira_ reporting process is restored; and (3) proposed collection of information.
submission@omb.eop.gov. All maintain records to identify what Although one comment was received, it
comments should be identified with the reports have been stored. did not respond to any of the four
OMB control number 0910–0701. Also Based on the number of information collection topics solicited
include the FDA docket number found
sradovich on DSK3GMQ082PROD with NOTICES
manufacturers that would be covered by in the notice under the PRA. We
in brackets in the heading of this the guidance, we estimate that therefore made no changes to our
document. approximately 5,000 firms will add the estimate of the burden for the
FOR FURTHER INFORMATION CONTACT: following to their COOP: (1) Instructions information collection, which remains
Domini Bean, Office of Operations, for reporting adverse events and (2) a as follows:
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![15154 Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Type of reporting responses per burden per Total hours
respondents responses
respondent response
Notify FDA when normal reporting is not feasible ............... 500 1 500 8 4,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
Number of Total annual Hours per
Type of recordkeeping records per Total hours
recordkeepers records record
recordkeeper
Add adverse event reporting plan to COOP ..................... 5,000 1 5,000 50 250,000
Maintain documentation of influenza pandemic conditions
and resultant high absenteeism ..................................... 500 1 500 8 4,000
Maintain records to identify what reports have been
stored and when the reporting process was restored ... 500 1 500 8 4,000
Total ............................................................................ .......................... ........................ ........................ ........................ 258,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 3, 2018. comments should be identified with the FD&C Act by limiting the provision to
Leslie Kux, OMB control number 0910–0577. Also reprocessed single-use devices (SUDs)
Associate Commissioner for Policy. include the FDA docket number found and the manufacturers who reprocess
[FR Doc. 2018–07154 Filed 4–6–18; 8:45 am] in brackets in the heading of this them. Under the amended provision, if
BILLING CODE 4164–01–P
document. the original SUD or an attachment to it
FOR FURTHER INFORMATION CONTACT: prominently and conspicuously bears
Amber Sanford, Office of Operations, the name of the manufacturer, then the
DEPARTMENT OF HEALTH AND Food and Drug Administration, Three reprocessor of the SUD is required to
HUMAN SERVICES White Flint North, 10A–12M, 11601 identify itself by name, abbreviation, or
Landsdown St., North Bethesda, MD symbol in a prominent and conspicuous
Food and Drug Administration 20852, 301–796–8867, PRAStaff@ manner on the device or attachment to
fda.hhs.gov. the device. If the original SUD does not
[Docket No. FDA–2011–N–0672]
prominently and conspicuously bear the
SUPPLEMENTARY INFORMATION: In
Agency Information Collection name of the manufacturer, the
compliance with 44 U.S.C. 3507, FDA
Activities; Submission for Office of manufacturer who reprocesses the SUD
has submitted the following proposed
Management and Budget Review; for reuse may identify itself using a
collection of information to OMB for
Comment Request; Prominent and detachable label that is intended to be
review and clearance.
Conspicuous Mark of Manufacturers affixed to the patient record.
on Single-Use Devices Prominent and Conspicuous Mark of The requirements of section 502(u) of
Manufacturers on Single-Use Devices the FD&C Act impose a minimal burden
AGENCY: Food and Drug Administration, OMB Control Number 0910–0577— on industry. This section of the FD&C
HHS. Extension Act only requires the manufacturer,
ACTION: Notice. packer, or distributor of a device to
Section 502 of the Federal Food, Drug,
include their name and address on the
SUMMARY: The Food and Drug and Cosmetic Act (FD&C Act) (21 U.S.C.
labeling of a device. This information is
Administration (FDA) is announcing 352), among other things, establishes
readily available to the establishment
that a proposed collection of requirements that the label or labeling of
a medical device must meet so that it is and easily supplied. From its
information has been submitted to the registration and premarket submission
Office of Management and Budget not misbranded and subject to
regulatory action. Section 301 of the database, FDA estimates that there are
(OMB) for review and clearance under 67 establishments that distribute
the Paperwork Reduction Act of 1995. Medical Device User Fee and
Modernization Act of 2002 (Pub. L. 107– approximately 427 reprocessed SUDs.
DATES: Fax written comments on the Each response is anticipated to take 0.1
250) amended section 502 of the FD&C
collection of information by May 9, hours (6 minutes) resulting in a total
Act to add section 502(u) to require
2018. burden to industry of 43 hours.
devices (both new and reprocessed) to
ADDRESSES: To ensure that comments on bear prominently and conspicuously the In the Federal Register of December
the information collection are received, name of the manufacturer, a generally 19, 2017 (82 FR 60207), FDA published
OMB recommends that written recognized abbreviation of such name, a 60-day notice requesting public
sradovich on DSK3GMQ082PROD with NOTICES
comments be faxed to the Office of or a unique and generally recognized comment on the proposed collection of
Information and Regulatory Affairs, symbol identifying the manufacturer. information. No comments were
OMB, Attn: FDA Desk Officer, Fax: 202– Section 2(c) of the Medical Device received.
395–7285, or emailed to oira_ User Fee Stabilization Act of 2005 (Pub. FDA estimates the burden of this
submission@omb.eop.gov. All L. 109–43) amends section 502(u) of the collection of information as follows:
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Document Created: 2018-04-07 02:39:30
Document Modified: 2018-04-07 02:39:30
| 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 May 9, 2018. | |
| Contact | Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected] | |
| FR Citation | 83 FR 15153 |
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