[Federal Register Volume 87, Number 51 (Wednesday, March 16, 2022)]
[Notices]
[Pages 14894-14897]
[FR Doc No: 2022-05514]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1960]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; MedWatch: The Food
and Drug Administration Safety Information and Adverse Event Reporting
Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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: Submit written comments (including recommendations) on the
collection of information by April 15, 2022.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0291. 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-45, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[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.

MedWatch: The FDA Safety Information and Adverse Event Reporting
Program

OMB Control Number 0910-0291--Revision

I. Background

    MedWatch is FDA's program for reporting serious reactions, product
quality problems, therapeutic inequivalence/failure, and product use
errors associated with FDA-regulated

products. Examples of these products include prescription and over-the-
counter medicines; biologics such as blood components, blood/plasma
derivatives, and gene therapies; medical devices such as hearing aids,
breast pumps, and pacemakers; combination products such as pre-filled
drug syringe, metered-dose inhalers, and nasal spray; special
nutritional products such as dietary supplements, medical foods, and
infant formulas; cosmetics such as moisturizers, makeup, shampoos, hair
dyes, and tattoos; and food, such as beverages and ingredients added to
foods.
    MedWatch receives reports from the public and, when appropriate,
publishes safety alerts intended to protect the public health. More
information regarding the MedWatch program, including user guides and
consumer assistance on reporting problems to FDA, may be found on our
website at https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program. Reports are submitted to FDA by
health professionals, patients, and consumers, and FDA issues an
acknowledgement upon receipt of the report. Forms may be downloaded
from our website at https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting and submitted by Fax or
mail following the instructions; by completing and submitting forms
online; or by calling FDA at 800-FDA-1088<PHONE_NUMBER>) and reporting
by telephone.
    Some adverse event reports (AERs) are required to be submitted to
FDA (mandatory reporting), while other reporting is done voluntarily
(voluntary reporting). Upon receipt of the report, it is directed to
the FDA center responsible for ensuring the product's compliance with
statutory requirements under the Federal Food, Drug, and Cosmetic Act
(FD&C Act) and/or any related authorities. Certain requirements
regarding mandatory reporting of adverse events or product problems
have been codified in Agency regulations, including those found in 21
CFR parts 310, 314, 514, 600, 803, 1114, and 1271.
    We are revising the information collection to include electronic
submission of AERs, currently approved in OMB control number 0910-0645.
Most reports are submitted using the Electronic Submissions Gateway
(ESG), our centralized system for securely receiving electronic
submissions. Reports may also be submitted via the Safety Reporting
Portal (SRP), found at https://www.safetyreporting.hhs.gov/SRP2/en/Home.aspx?sid=c16bcd94-42a8-4a68-9272-df4a62d8462c, which is intended
to streamline the process of reporting product safety issues to FDA
using ``Rational Questionnaires.''

II. MedWatch Reporting Forms

A. MedWatch Form FDA 3500 (Voluntary Reporting for Health
Professionals)

    Form FDA 3500 is used by healthcare professionals as well as
consumers to submit all reports not mandated by Federal law or
regulation. Individual health professionals are not required to submit
reports with the exception of certain adverse reactions following
immunization with vaccines as mandated by the National Childhood
Vaccine Injury Act of 1986 (42 U.S.C. 300aa-1). Form FDA 3500 may be
used to report serious adverse events, product problems, and product
use errors and therapeutic failures. Reporting is supported for drugs,
non-vaccine biologicals, medical devices, special nutritional products,
cosmetics, and nonprescription (over-the-counter) human drug products
marketed without an approved application. Form FDA 3500 may also be
used to submit reports about tobacco products and dietary supplements.

B. MedWatch Form FDA 3500A (Mandatory Reporting)

    Form FDA 3500A is used by manufacturers, user facilities,
distributers, importers, and other respondents subject to mandatory
reporting. Mandatory reporting of adverse events or product experiences
is governed by statute and often codified in Agency regulations.
Mandatory reporting of adverse reactions for human cells, tissues, and
cellular- and tissue-based products is codified at 21 CFR 1271.350.
    Reporting Under Sections 760 and 761 of the FD&C Act. The Dietary
Supplement and Nonprescription Drug Consumer Protection Act of 2006
(Pub. L. 109-462) amended the FD&C Act by adding sections 760 and 761
(21 U.S.C. 379aa and 379aa-1). Section 760 of the FD&C Act defines
``adverse event'' and ``serious adverse event'' for nonprescription
drugs and prescribes specific reporting requirements, submission
timing, and associated recordkeeping. The final guidance document
entitled ``Postmarketing Adverse Event Reporting for Nonprescription
Human Drug Products Marketed Without an Approved Application,''
available for download at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarketing-adverse-event-reporting-nonprescription-human-drug-products-marketed-without-approved,
discusses the statutory requirements and provides instructions on the
reporting elements and the use of Form FDA 3500A. Similarly, section
761 of the FD&C Act defines ``adverse event'' and ``serious adverse
event'' for dietary supplements and prescribes specific reporting
requirements, submission timing, and associated maintenance of
reporting records. The document 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,''
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-adverse-event-reporting-and-recordkeeping-dietary, discusses these
statutory requirements and provides instruction on the use and
submission of Form FDA 3500A and discusses records required under
section 761.

C. MedWatch Form FDA 3500B (Voluntary Reporting for Consumers)

    Form FDA 3500B is a consumer-friendly version of Form FDA 3500 and
is used for voluntary reporting. Respondents with access to the
internet may visit our website at https://www.fda.gov and download Form
FDA 3500B or contact us for assistance with completing and submitting
the information. Form FDA 3500B is available in both English and
Spanish.

III. FDA Safety Reporting Portal Rational Questionnaires

    FDA currently receives several types of adverse event reports
electronically via the SRP using rational questionnaires. These
include:

1. Reportable Food Registry

    Section 417 of the FD&C Act (21 U.S.C. 350f) defines ``reportable
food'' and establishes reporting requirements for articles of foods
(other than infant formula or dietary supplements) for which there is a
reasonable probability that the use of, or exposure to, will cause
serious adverse health consequences or death to humans or animals. We
designed the reportable food registry (RFR) rational questionnaire to
enable us to quickly identify, track, and remove from commerce an
article of food (other than infant formula or dietary supplements) for
which there is a reasonable probability that the use of, or exposure
to, such article of food will cause

serious adverse health consequences or death to humans or animals.
FDA's Center for Food Safety and Applied Nutrition uses the information
to help ensure that these products are quickly and efficiently removed
from the market to prevent foodborne illnesses. Both mandatory and
voluntary RFR reports must be submitted via the SRP.

2. Food, Infant Formula, and Cosmetic Adverse Event Reports

    Rational questionnaires have also been developed for submitting
adverse event reports for dietary supplements, food, infant formula,
and cosmetics.

3. Animal Food Adverse Event and Product Problem Reports

    Section 1002(b) of the FDA Amendments Act of 2007 (Pub. L. 110-85)
directs the Secretary to establish an early warning and surveillance
system to identify adulteration of the pet food supply and outbreaks of
illness associated with pet food. We developed the Pet Food Early
Warning System rational questionnaire as a user-friendly data
collection tool, as well as a questionnaire for collecting voluntary
adverse event reports associated with livestock food. Information
collected in these voluntary adverse event reports contributes to our
ability to identify adulteration of the livestock food supply and
outbreaks of illness associated with livestock food. We use the
information collected to help ensure that such products are quickly and
efficiently removed from the market to prevent foodborne illnesses.

4. Voluntary Tobacco Product Adverse Event and Product Problem Reports

    The Center for Tobacco Products (CTP) has developed two voluntary
rational questionnaires on the SRP. The first is utilized by consumers
and concerned citizens to report tobacco product adverse event or
product problems. A second rational questionnaire is used by tobacco
product investigators in clinical trials with investigational tobacco
products. Both CTP voluntary rational questionnaires capture tobacco-
specific adverse event and product problem information from reporting
entities such as healthcare providers, researchers, consumers, and
other users of tobacco products.
    In the Federal Register of June 30, 2021 (86 FR 34754), we
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received requesting
clarification with regard to certain terms applicable to medical device
reporting and exemptions from reporting. We note that information
collection pertaining to medical device reporting is approved under OMB
control number 0910-0437. The comment also discussed electronic
reporting currently approved in OMB control number 0910-0645. Upon
consideration of the comment and to help increase our organizational
efficiency, we are consolidating the related reporting activities
currently approved in OMB control number 0910-0645 into this single
information collection request. Upon OMB approval of our request, we
will discontinue OMB control number 0910-0645. In consideration of the
comment, we have also proposed the following updates to the information
collection instruments to help clarify information to be included in
the corresponding data fields:
    1. Revising the ``gender'' field to Forms FDA 3500, 3500A, and
3500B; to align with Centers for Disease Control and Prevention's use
of these terms (https://www.cdc.gov/hiv/clinicians/transforming-health/health-care-providers/collecting-sexual-orientation.html), with the
exception of the term ``Undifferentiated,'' which is included in the
CDISC (Clinical Data Interchange Standards Consortium) language
(premarket) standards (https://www.cdisc.org/kb/articles/sex-and-gender);
    2. Revising Section B of Form FDA 3500 to the ``product problem''
field to include information about the root cause(s) of problem(s).
    3. Revising instructions to clarify reporting instructions for
paper-based reporting pertaining to adverse events associated with
tobacco products; and
    4. Revising instructions to clarify the term ``smoking'' refers to
use of combusted products (cigarettes, cigars, pipes) to ``tobacco
product use,'' which encompasses combusted and non-combusted tobacco
products.
    We estimate the burden of the information collection as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                  Number of
                   FDA form                       Number of     responses per   Total annual          Average burden  per response          Total hours
                                                 respondents     respondent       responses
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Reportable Foods Registry--Mandatory Reports.             875               1             875  0.6 (36 minutes).........................             525
Reportable Foods Registry--Voluntary Reports.               5               1               5  0.6 (36 minutes).........................               3
Food, Infant Formula, and Cosmetic Adverse              1,165             1.2           1,398  0.6 (36 minutes).........................             839
 Event Reports.
Voluntary Dietary Supplement Adverse Event                360             1.2             432  0.6 (36 minutes).........................             259
 Reports.
Mandatory Dietary Supplement Adverse Event                 80              12             960  1........................................             960
 Reports.
Animal Food: Pet Food Reports................           2,024               1           2,024  0.6 (36 minutes).........................        1,214.40
Animal Food: Livestock Food Reports..........              25               1              25  0.6 (36 minutes).........................              15
Voluntary Tobacco Product Health Problem or               204               1             204  0.6 (36 minutes).........................             122
 Product Problem (i.e., adverse experience)
 Reports to SRP (both questionnaires).
Mandatory Tobacco Product Health Problem or                 1               1               1  0.6 (36 minutes).........................               1
 Product Problem (i.e., adverse experience)
 Reports.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............           5,924  .........................................         3,938.4
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimate of the number of respondents and the total annual
responses is based primarily on mandatory and voluntary adverse event
reports submitted to the Agency. The estimated total annual responses
are based on initial reports. Followup reports, if any, are not counted
as new reports. Based on our experience with

adverse event reporting, we assume it takes respondents 0.6 hour to
submit a voluntary adverse event report via the SRP, 1 hour to submit a
mandatory adverse event report via the SRP (except CTP, which estimates
0.6 hour), and 0.6 hour to submit a mandatory AER via the ESG (gateway-
to-gateway transmission).
    CTP used two data sources to estimate the reporting burden for
tobacco product AEs. CTP researched the number of voluntary AE reports
submitted to the center since the launch of the first tobacco
questionnaire in the SRP in 2014. Our records indicated a total of
1,426 initial reports over the last 7 full calendar years. We used the
total number of reports to average the number of yearly reports to 204.
As referenced above, the premarket tobacco product application rule
requires firms to submit adverse experience reports for tobacco
products with marketing orders. The burden for these mandatory reports
has been approved under OMB control number 0910-0879. For this
collection, we have included 1 hour to acknowledge the inclusion under
this collection. Therefore, the estimate for CTP voluntary and
mandatory reports is expected to be 123 hours.
    The submission of mandatory reports associated with drug products
and biological drug products is accounted for and approved under OMB
control number 0910-0230; the submission of mandatory reports
associated with the Vaccine Adverse Event Reporting System is accounted
for and approved under OMB control number 0910-0308; medical device
report submissions are accounted for and approved under OMB control
number 0910-0437; and the submission of mandatory reports associated
with animal drug products is accounted for and approved under OMB
control number 0910-0284.

    Dated: March 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-05514 Filed 3-15-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 214 (Wednesday, November 4, 2020)]
[Notices]
[Page 70216]
[FR Doc No: 2020-24377]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-90286; File No. SR-NYSEArca-2020-80]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of
Designation of a Longer Period for Commission Action on a Proposed Rule
Change, as Modified by Amendment No. 1, To List and Trade Shares of the
Alger Mid Cap 40 ETF and Alger 25 ETF Under Rule 8.900-E, Managed
Portfolio Shares

October 29, 2020.
    On September 1, 2020, NYSE Arca, Inc. (``NYSE Arca'') filed with
the Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change to list and trade
shares of the Alger Mid Cap 40 ETF and Alger 25 ETF under Rule 8.900-E
(Managed Portfolio Shares). The proposed rule change was published for
comment in the Federal Register on September 21, 2020.\3\ On October 7,
2020, NYSE Arca filed Amendment No. 1 to the proposed rule change.\4\
The Commission has received no comments on the proposal.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 89869 (September 15,
2020), 85 FR 59354.
    \4\ Amendment No. 1, which amended and replaced the proposed
rule change in its entirety, is available on the Commission's
website at: https://www.sec.gov/comments/sr-nysearca-2020-80/srnysearca202080.htm.
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    Section 19(b)(2) of the Act \5\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding, or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for this proposed rule change
is November 5, 2020. The Commission is extending this 45-day time
period.
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    \5\ 15 U.S.C. 78s(b)(2).
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    The Commission finds it appropriate to designate a longer period
within which to take action on the proposed rule change so that it has
sufficient time to consider the proposed rule change. Accordingly, the
Commission, pursuant to Section 19(b)(2) of the Act,\6\ designates
December 20, 2020 as the date by which the Commission shall either
approve or disapprove, or institute proceedings to determine whether to
disapprove, the proposed rule change (File No. SR-NYSEArca-2020-80).
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    \6\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
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    \7\ 17 CFR 200.30-3(a)(31).
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Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2020-24377 Filed 11-3-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 92 (Thursday, May 12, 2016)]
[Notices]
[Pages 29556-29557]
[FR Doc No: 2016-11191]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL00-95-288]

San Diego Gas & Electric Company v. Sellers of Energy and
Ancillary Services Into Markets Operated by the California Independent
System Operator Corporation and the California Power Exchange; Notice
of Compliance Filing

    Take notice that on May 5, 2016, the California Power Exchange
Corporation submitted its Refund Rerun Compliance Filing pursuant to
the Federal Energy Regulatory Commission's (Commission) July 15, 2011
Order Accepting Compliance Filings and Providing Guidance. \1\
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    \1\ San Diego Gas & Elec. Co. v. Sellers of Energy and Ancillary
Servs., 136 FERC ] 61,036 (2011).
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    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed

docket(s). For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on May 26, 2016.

    Dated: May 6, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-11191 Filed 5-11-16; 8:45 am]
BILLING CODE 6717-01-P