[Federal Register Volume 80, Number 104 (Monday, June 1, 2015)]
[Notices]
[Pages 31042-31048]
[FR Doc No: 2015-13102]

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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 Medical Products Reporting Program

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 July 1,
2015.

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:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0291.
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_ADDRESS>
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 Medical Products Reporting Program OMB Control Number
0910-0291--Extension

I. Background

    To ensure the marketing of safe and effective products, it is
critical that postmarketing adverse outcomes and product problems are
reported for all FDA-regulated human healthcare products, including
drugs (prescription and nonprescription), biologics, medical devices,
dietary supplements and other special nutritional products (e.g. infant
formula and medical foods), and cosmetics. To facilitate reporting on
human medical products (except vaccines) during their postapproval and
marketed lifetimes, three forms (collectively known as the MedWatch
forms) are available from the Agency. Form FDA 3500 is intended to be
used for voluntary (i.e., not mandated by law or regulation) reporting
by healthcare professionals. Form FDA 3500B is written in plain
language and is intended to be used for voluntary reporting (i.e., not
mandated by law or regulation) by consumers (i.e., patients and their
caregivers). Form FDA 3500A is used for mandatory reporting (i.e.,
required by law or regulation). When FDA receives this information from
healthcare professionals, patients, or consumers, the report becomes
data that will be used to assess and evaluate the risk associated with
the product. FDA will then take whatever action is necessary to reduce,
mitigate, or eliminate the public's exposure to the risk through
regulatory and public health interventions.

Authorizing Statutes and Codified Regulations

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
353b, 355, 360i, 360l, and 393) and the Public Health Service Act (42
U.S.C. 262) represent the statutory authority for the FDA to collect
mandatory adverse event reports from regulated industry on medical
products once approved for marketing to monitor the safety of drugs,
biologics, medical devices, and dietary

supplements. There are no laws or regulations mandating the postmarket
reporting for medical foods, infant formula, cosmetics, or tobacco
products, and the reporting for these products is done voluntarily.
    Requirements regarding mandatory reporting of adverse events or
product problems have been codified in parts 310, 314, 600, and 803 (21
CFR 310, 314, 600, and 803), specifically Sec. Sec.  310.305, 314.80,
314.98, 600.80, 803.30, 803.50, 803.53, 803.56, and specified in
sections 503B, 760, and 761 (21 U.S.C. 379aa and 379aa-1) of the FD&C
Act. Mandatory reporting of adverse reactions for human cells, tissues,
and cellular- and tissue-based products (HCT/Ps) has been codified in
21 CFR 1271.350.

II. Use of Form 3500 (Voluntary Reporting)

    This voluntary version of the form may be used by healthcare
professionals to submit all reports not mandated by Federal law or
regulation. Individual health professionals are not required by law or
regulation to submit reports to the Agency or the manufacturer 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). Reports for vaccines are not submitted via
MedWatch or MedWatch forms, but are submitted to the Vaccines Adverse
Event Reporting System (see http://vaers.hhs.gov), which is jointly
administered by FDA and the Centers for Disease Control and Prevention.
    Hospitals are not required by Federal law or regulation to submit
reports associated with drug products, biological products, or special
nutritional products. However, hospitals and other user facilities are
required by Federal law to report medical device-related deaths and
serious injuries.
    Under Federal law and regulation, section 761(b)(1) of the FD&C
Act, a dietary supplement manufacturer, packer, or distributor whose
name appears on the label of a dietary supplement marketed in the
United States is required to submit to FDA any serious adverse event
report it receives regarding use of the dietary supplement in the
United States. However, FDA bears the burden to gather and review
evidence that a dietary supplement may be adulterated under section 402
of the FD&C Act (21 U.S.C. 342) after that product is marketed.
Therefore, the Agency depends on the voluntary reporting by health
professionals, and especially by consumers, of suspected serious
adverse events and product quality problems associated with the use of
dietary supplements. All dietary supplement reports were previously
received by the Agency on paper versions of Form FDA 3500 (or Form FDA
3500B) (by mail or fax). Currently, electronic reports may be sent to
the Agency via an online submission route called the Safety Reporting
Portal (http://www.safetyreporting.hhs.gov/). In that case, Form FDA
3500 (or Form FDA 3500B) is not used.
    Form FDA 3500 may be used to report to the Agency serious adverse
events, product problems, and product use errors and therapeutic
failures. The form is provided in both paper and electronic formats.
Reporters may mail or fax paper forms to the Agency (a fillable PDF
version of the form is available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf) or reporters may
electronically submit a report via the MedWatch Online Voluntary
Reporting Form (https://www.accessdata.fda.gov/scripts/medwatch/).
Reporting is supported for drugs, non-vaccine biologicals, medical
devices, special nutritional products, cosmetics, and non-prescription
(over the counter (OTC)) human drug products marketed without an
approved application. The paper form may also be used to submit reports
about tobacco products and dietary supplements. Electronic reports for
tobacco products and dietary supplements may be submitted to the Agency
via an online submission route called the Safety Reporting Portal
(http://www.safetyreporting.hhs.gov/).

III. Use of Form 3500B (Consumer Voluntary Reporting)

    This voluntary version of the form may be used by consumers (i.e.
patients and their caregivers) to submit reports not mandated by
Federal law or regulation. Individual patients or their caregivers are
not required by law or regulation to submit reports to the Agency or
the manufacturer.
    FDA supports and encourages direct reporting to the Agency by
consumers of suspected serious adverse outcomes and other product
problems associated with human medical products, (http://www.fda.gov/Safety/ReportaProblem/default.htm). Since the inception of the MedWatch
program, launched in July 1993 by then FDA Commissioner David Kessler,
the program has been promoting and facilitating voluntary reporting by
both the general public and healthcare professionals. FDA has further
encouraged voluntary reporting by requiring inclusion of the MedWatch
toll-free phone number or the MedWatch Internet address on all
outpatient drug prescriptions dispensed, as mandated by section 17 of
the Best Pharmaceuticals for Children Act (Pub. L. 107-109).
    On March 25, 2008, section 906 of the Food and Drug Administration
Amendments Act (Pub. L. 110-85) amended section 502(n) of the FD&C Act
and mandated that published direct-to-consumer advertisements for
prescription drugs include the following statement printed in
conspicuous text (this includes vaccine products): ``You are encouraged
to report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/safety/medwatch, or call 1-800-FDA-1088.''
    Most private vendors of consumer medication information, the drug
product-specific instructions dispensed to consumers at outpatient
pharmacies, remind patients to report ``side effects'' to FDA and
provide contact information to permit reporting via the MedWatch
process.
    Since 2013, FDA has made available Form FDA 3500B. It was proposed
during the previous authorization in 2012 and is a version of Form FDA
3500 that is tailored for consumers and written in plain language (in
conformance with the Plain Writing Act of 2010 (Pub. L. 111-274) http://www.gpo.gov/fdsys/pkg/PLAW-111publ274/pdf/PLAW-111publ274.pdf).
    Form FDA 3500B evolved from several iterations of draft versions,
with input from human factors experts, from other regulatory agencies,
and with extensive input from consumer advocacy groups and the general
public. Form FDA 3500B may be used to report to the Agency adverse
events, product problems, and product use errors. The form is provided
in both paper and electronic formats. Reporters may mail or fax paper
forms to the Agency (a fillable PDF version of the form is available at
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf) or electronically submit a report via the MedWatch
Online Voluntary Reporting Form (https://www.accessdata.fda.gov/scripts/medwatch/). Reporting is supported for drugs, non-vaccine
biologicals, medical devices, special nutritional products, cosmetics,
and non-prescription OTC human drug products marketed without an
approved application. The paper form may also be used to submit reports
about tobacco products and dietary supplements.
    Electronic reports for tobacco products and dietary supplements may
be submitted to the Agency via an online submission route called the

Safety Reporting Portal (http://www.safetyreporting.hhs.gov/).

IV. Use of Form FDA 3500A (Mandatory Version)

A. Drug and Biological Products

    In sections 505(b), 505(j) (21 U.S.C. 354(b) and (j)), 503B, and
704 (21 U.S.C. 374) of the FD&C Act, Congress has required that
important safety information relating to all human drug products be
made available to the FDA so that it can take appropriate action to
protect the public health when necessary. Section 702 of the FD&C Act
(21 U.S.C. 372) authorizes investigational powers to the FDA for
enforcement of the FD&C Act. These statutory requirements regarding
mandatory reporting have been codified by FDA under parts 310 and 314
(drugs) and 600 (biological products). Mandatory reporting of adverse
reactions for HCT/Ps has been codified in Sec.  1271.350.

B. OTC Monograph Drug Products and Dietary Supplements

    Section 760 of the FD&C Act provides for mandatory safety reporting
for non-prescription human drug products marketed without an approved
application as described in the Dietary Supplement and Nonprescription
Drug Consumer Protection Act (Pub. L. 109-462), which became law on
December 22, 2006. The law requires manufacturers, packers, and
distributors of nonprescription, OTC human drug products marketed
without an approved application (OTC monograph drug products) to submit
reports of adverse experiences from domestic sources. The law also
requires reports of serious adverse events to be submitted to FDA by
manufacturers of dietary supplements.

C. Postmarketing Safety Reports--Changes in Format Starting in June
2015

    Current requirements specify that postmarketing adverse experience
reports must be submitted on paper on Form FDA 3500A (or the Council
for International Organizations of Medical Sciences) I form for
serious, unexpected adverse experiences from a foreign source). For the
last several years the Agency has accepted electronic submissions in
lieu of the paper Form FDA 3500A on the condition they are submitted in
a manner that the Agency can process, review, and archive. On June 10,
2014, the Agency issued a final rule entitled ``Postmarketing Safety
Reports for Human Drug and Biological Products; Electronic Submission
Requirements'' (79 FR 33072) that requires electronic submission of all
mandatory postmarketing safety reports, including individual case
safety reports. Entities with mandatory reporting obligations under
parts 310 and 314 (drugs) and 600 (biological products) and specified
under section 760 of the FD&C Act must implement this rule within 1
year of the issuance date (by June 10, 2015). For more information, go
to http://www.gpo.gov/fdsys/pkg/FR-2014-06-10/pdf/2014-13480.pdf.

D. Medical Device Products

    Section 519 of the FD&C Act (21 U.S.C. 360i) requires manufacturers
and importers of devices intended for human use to establish and
maintain records, make reports, and provide information, as the
Secretary of Health and Human Services may, by regulation, reasonably
be required to provide assurance that such devices are not adulterated
or misbranded and to otherwise assure its safety and effectiveness. The
Safe Medical Devices Act of 1990 (Pub. L. 101-629), signed into law on
November 28, 1990, amends section 519 of the FD&C Act. The amendment
requires that user facilities such as hospitals, nursing homes,
ambulatory surgical facilities, and outpatient treatment facilities
report deaths related to medical devices to FDA and to the
manufacturer, if known. Serious illnesses and injuries are to be
reported to the manufacturer or to FDA if the manufacturer is not
known. These statutory requirements regarding mandatory reporting have
been codified by FDA under part 803. Part 803 mandates the use of Form
FDA 3500A for reporting to FDA on medical devices. The Medical Device
User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250),
signed into law October 26, 2002, amended section 519 of the FD&C Act.
The MDUFMA amendment (section 303) required FDA to revise the MedWatch
forms to facilitate the reporting of information relating to
reprocessed single-use devices, including the name of the re-processor
and whether the device has been reused.

V. Proposed Modifications to Existing Forms FDA 3500, 3500A, and 3500B

A. General Changes

    The proposed modifications to Forms FDA 3500 and 3500A reflect
changes that will bring the forms into conformation, since the previous
authorization in 2012, with current regulations, rules, and guidances.

B. Changes Proposed for Form FDA 3500

    Formatting modifications are proposed to several fields to enhance
the clarity and utility of the information collected. In section A2, it
is proposed that checkboxes for years, months, weeks, and days be added
to permit clarity about the age of the patient. In section A4, it is
proposed that checkboxes for pounds (lb) and kilograms (kg) be added to
permit clarity about the patient's weight. To permit clarity and
utility for the dates being reported, it is proposed that field labels
and instructions be modified to ask the reporter to use the format DD-
MMM-YYYY. A watermark will be added to the date fields to prompt the
reporter to enter data using this format. This proposed change will
reduce the data-entry burden for FDA by making the form more easily
scanned by the optical character recognition (OCR) software used by the
Agency. This change is proposed for all of the date fields on the form
including: A2 (Date of Birth), B2 (Death), B3, B4, C (Returned to
Manufacturer On), D7, E4 (Expiration Date), E6, and E7.
    In recognition of OMB 1997 Revisions to the Standards for the
Classification of Federal Data on Race and Ethnicity, and as part of
FDA's Action Plan to Enhance the Collection and Availability of
Demographic Subgroup Data (http://www.fda.gov/downloads/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/UCM410474.pdf) developed in
response to the requirement in section 907 of the Food and Drug
Administration Safety and Innovation Act (FDASIA) of 2012 (Pub. L.112-
144), changes are proposed to the location and formatting of the fields
containing data about the patient's race. It is proposed that race be
deleted from the descriptor in section B, field B7, that requests
``Other Relevant History, Including Preexisting Medical Conditions
(e.g. allergies, race, pregnancy, smoking and alcohol use, liver/kidney
problems, etc.).'' Instead, it is proposed that a new race and
ethnicity field be added to section A, ``Patient Information.'' The
proposed ethnicity field will be numbered 5a and state ``Ethnicity
(Check single best answer)'' with corresponding checkboxes for
``Hispanic/Latino'' and ``Not Hispanic/Latino.'' Adjacent to this
field, the ``Race'' field will be numbered 5b and state ``Race (Check
all that apply).'' It will contain checkboxes for ``Asian,'' ``American
Indian or Alaskan Native,'' ``Black or African American,''

``White,'' and ``Native Hawaiian or Other Pacific Islander.''
    Changes are proposed to the location, formatting, and labeling of
fields related to the suspect product and its availability for
evaluation to allow the product's identifying information to be grouped
in one place, and increase the likelihood that this information is
entered. In section D, field D1 will be used to request data for ``Name
and Strength,'' ``Manufacturer/Compounder,'' as well as ``Lot #,'' and
``NDC # or Unique ID #'' for up to two suspect medical products.
    In 2013, the Drug Quality and Security Act (Pub. L. 113-54) added
new section 503B to the FD&C Act, under which a compounder may elect to
become an outsourcing facility by registering with FDA. Outsourcing
facilities are required to report adverse events to FDA in accordance
with the content and format requirements established through guidance
or regulation under Sec.  310.305. In addition to mandatory reporting,
many adverse events related to compounded drugs are reported
voluntarily by healthcare professionals and consumers. Therefore, FDA
is proposing changes to the voluntary versions of the MedWatch forms
(i.e. Forms FDA 3500 and 3500B) to improve the ability to rapidly
identify reports involving compounded drugs. The existing field
(section D, field D1) that contains the descriptor ``Manufacturer''
will be relabeled ``Manufacturer/Compounder.'' Correspondingly, a
checkbox for ``Manufacturer/Compounder'' will be added to the existing
field (section G, field G4) ``Also Reported to.'' It is proposed that a
new field be added to the section entitled ``Suspect Products.'' The
new field will be numbered and include a descriptor ``Is the Product
Compounded?'' with corresponding checkboxes for ``Yes'' or ``No.''
    The new field will also include a descriptor ``Is the Product Over-
the-Counter'' with corresponding checkboxes for ``Yes'' or ``No.'' The
instructions to the form will be updated accordingly. The form remains
a three-page form with all the main data fields on page one, with
instructions for use and a self-addressed, postage-paid return mailer
on the reverse side of page one, and page three being a continuation
page for additional information should reporters need extra space.

C. Changes Proposed for Form FDA 3500A

    Formatting modifications are proposed to several fields to enhance
the clarity and utility of the information collected. In section A2, it
is proposed that checkboxes for years, months, weeks, and days be added
to permit clarity about the age of the patient. In section A4, it is
proposed that checkboxes for pounds (lb) and kilograms (kg) be added to
permit clarity about the patient's weight. To permit clarity and
utility for the dates being reported, it is proposed that field labels
and instructions be modified to ask the reporter to use the format DD-
MMM-YYYY. A watermark will be added to the date fields to prompt the
reporter to enter data using this format. This proposed change will
reduce the data-entry burden for FDA by making the form more easily
scanned by the OCR software used by the Agency. This change is proposed
for all of the date fields on the form including: A2 (Date of Birth),
B2 (Death), B3, B4, C7, D4 (Expiration Date), D6, D7, D10 (Returned to
Manufacturer on), F6, F8, F11, F13, G4, and H4.
    In recognition of OMB's 1997 Revisions to the Standards for the
Classification of Federal Data on Race and Ethnicity, and as part of
FDA's Action Plan to Enhance the Collection and Availability of
Demographic Subgroup Data (http://www.fda.gov/downloads/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/UCM410474.pdf) developed in
response to the requirement in section 907 of FDASIA, changes are
proposed to the location and formatting of the fields containing data
about the patient's race. It is proposed that race be deleted from the
descriptor in section B, field B7, that requests ``Other Relevant
History, Including Preexisting Medical Conditions (e.g. allergies,
race, pregnancy, smoking and alcohol use, liver/kidney problems,
etc.).'' Instead, it is proposed that a new race and ethnicity field be
added to section A, ``Patient Information.'' The proposed ethnicity
field will be numbered 5a, and state ``Ethnicity (Check single best
answer)'' with corresponding checkboxes for ``Hispanic/Latino'' and
``Not Hispanic/Latino.'' Adjacent to this field, the ``Race'' field
will be numbered 5b, and state ``Race (Check all that apply).'' It will
contain checkboxes for ``Asian,'' ``American Indian or Alaskan
Native,'' ``Black or African American,'' ``White,'' and ``Native
Hawaiian or Other Pacific Islander.''
    Changes are proposed to the location, formatting, and labeling of
fields related to the suspect product and its availability for
evaluation to allow the product's identifying information to be grouped
in one place and increase the likelihood that this information is
entered. For consistency and clarity, it is proposed that many of the
fields in the suspect products sections on Forms FDA 3500 and 3500A be
mirrored. For Form FDA 3500A, it is proposed that the current section
C, field C1, ``Name (Give labeled strength & mfr/labeler),'' also be
used to request data for ``Lot #'' and ``NDC # or Unique ID #.''
Section C, field C1 will be relabeled ``Name, Manufacturer/Compounder,
Strength.'' Proposed field C1 will contain distinct areas for ``Name
and Strength,'' ``Manufacturer/Compounder,'' ``NDC # or Unique ID #,''
and ``Lot #'' for up to two suspect products. Since the information
will now be captured in proposed field C1, separate fields for ``Lot
#'' and ``NDC #/Unique ID #'' (C6 and C9 from the current form) will
not be needed. The currently numbered field C2, ``Dose, Frequency &
Route Used,'' will be renumbered C3. It will also be reformatted to
have three distinct areas for dose, frequency, and route, respectively,
for up to two suspect products. Current field C3, ``Therapy Dates,''
will be renumbered C4, and current field C4, ``Diagnosis for Use,''
will be renumbered C5. Current field C5, ``Event Abated After Use
Stopped or Dose Reduced,'' will be renumbered C9, and field C8, ``Event
Reappeared After Reintroduction?'' will be renumbered C10. The field
for expiration date will be renumbered C8, and the field for
concomitant medical products and therapy dates (current field C10) will
be renumbered C2.
    As stated previously, in 2013, the Drug Quality and Security Act
added new section 503B to the FD&C Act, under which a compounder may
elect to become an outsourcing facility by registering with FDA.
Outsourcing facilities are required to report adverse events to FDA in
accordance with the content and format requirements established through
guidance or regulation under Sec.  310.305. To facilitate
implementation of this mandatory reporting requirement, changes will
need to be made to the existing Form FDA 3500A. It is proposed that a
new field be added to section G1 that contains the descriptor
``Compounding Outsourcing Facility 503B?'' with a corresponding
checkbox for ``Yes.'' It is also proposed that a new field be added to
section C, ``Suspect Products.'' The new field will be numbered C6 and
include a descriptor ``Is the Product Compounded?'' with corresponding
checkboxes for ``Yes'' or ``No'' (for up to two suspect products). The
instructions to the form will be updated accordingly.
    In addition, a new field numbered C7 will be added and ``Is the
Product Over-the-Counter?'' with corresponding

checkboxes for ``Yes'' or ``No'' (for up to two suspect products). The
instructions to the form will be updated accordingly.
    Additionally, for clarity, in section G, field G5, the area labeled
``(A)NDA #'' will be split into two separate areas--one for ``ANDA #''
and one for ``NDA #.''

D. Changes Proposed for Form FDA 3500B

    For consistency, and to improve the quality of the data received,
the changes being proposed on the voluntary Form FDA 3500 (for use by
healthcare professionals) are also being proposed on the voluntary Form
FDA 3500B (for use by consumers). Formatting modifications are being
proposed to several fields to enhance the quality, utility, and clarity
of the information. In section D, the field entitled ``Age (at time the
problem occurred) or Birth Date'' will be separated into separate
fields for age and date of birth. In the field for ``Age,'' checkboxes
for years, months, weeks, and days will be added to permit clarity
about the age of the patient. Similarly, for the field in section D
labeled ``Weight,'' checkboxes for pounds (lb) and kilograms (kg) will
be added to permit clarity about the patient's weight. The instructions
will be modified accordingly. To permit clarity about the dates being
reported, field labels and instructions will be modified to ask the
reporter to use the format DD-MMM-YYYY. A watermark will be added to
the field to prompt the reporter to respond using this format. This
will also reduce the data entry burden by making the form more easily
scanned by the OCR software used by FDA. All of the date fields on the
form will be affected by this proposed change. These include section A
(date the problem occurred, death), section B (expiration date, date
the person first started taking or using this product, date the person
stopped taking or using this product), section C (date the implant was
put in, date the implant was taken out), section D (date of birth), and
section E (today's date).
    A formatting modification to the field in section D that is
currently labeled ``Race'' is being proposed in recognition of OMB 1997
Revisions to the Standards for the Classification of Federal Data on
Race and Ethnicity, and as part of FDA's Action Plan to Enhance the
Collection and Availability of Demographic Subgroup Data (http://www.fda.gov/downloads/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/UCM410474.pdf) developed in response to the requirement in
section 907 of FDASIA. It is proposed that the field be relabeled
``Race (Check all that apply)'' and contain checkboxes for ``Asian,''
``American Indian or Alaskan Native,'' ``Black or African American,''
``White,'' and ``Native Hawaiian or Other Pacific Islander.'' It is
also proposed that the field contain an adjacent area labeled
``Ethnicity (Check single best answer)'' with corresponding checkboxes
for ``Hispanic/Latino'' and ``Not Hispanic/Latino.''
    As discussed previously in this notice, many adverse events related
to compounded drugs are reported voluntarily by healthcare
professionals and consumers. Therefore, FDA is proposing changes to the
voluntary versions of Forms FDA 3500 and 3500B to improve the Agency's
ability to rapidly identify reports involving compounded drugs. FDA
proposes to add a field to section B with the label ``Is the Product
Compounded?'' and corresponding checkboxes for ``Yes'' or ``No.'' FDA
also proposes to add a field to section B with the label ``Is the
Product Over-the-Counter'' with corresponding checkboxes for ``Yes'' or
``No.''
    Finally, to improve clarity and to be consistent with Form FDA
3500, FDA proposes to reword the last field of section E that currently
asks ``May we give your name and contact information to the company
that makes the product (manufacturer) to help them evaluate the
product?'' to ``If you do NOT want your identity disclosed to the
manufacturer, place an `X' in this box.''
    Items that we proposed in the 60-day notice that have changed: The
proposed change to Form FDA 3500 to merge sections C and D has been
retracted; therefore, the sections will not be re-sequenced on Form FDA
3500. For the proposed new field ``Is product compounded or over-the-
counter'' (proposed on Forms FDA 3500, 3500A and 3500B), the descriptor
``Check all that apply'' will be deleted and these will be broken out
into two separate questions, in two separate fields, with corresponding
``Yes'' and ``No'' checkboxes for up to two suspect products. The
proposal to add a new ``compounder'' checkbox to Form 3500 Field G4 has
been retracted. Instead the existing manufacturer checkbox will be
relabeled ``manufacturer/compounder.'' The proposal to add a new field
``Product Available for Evaluation?'' to the ``suspect products''
section of the Form FDA 3500A was retracted. The proposed changes
outlined above reflect these differences. We have reviewed the name
address field for Forms FDA 3500 and 3500A and believe data quality
would be improved if separate fields for last name, first name,
address, state, ZIP code, and Country were also included instead of one
field labeled ``name and address'' to capture all of that information.
    In the Federal Register of December 11, 2014 (79 FR 73591), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Four comments were received.
Comments Affecting All Three FDA Forms (3500, 3500A, 3500B)
    (Comment 1) One commenter recommended the option of an ``unknown''
check box for race/ethnicity.
    (Response) FDA disagrees with this comment as it is inconsistent
with the OMB standards for the classification of Federal data on race
and ethnicity.
    (Comment 2) One commenter requested an implementation date of 18
months after publication of the finalized form.
    (Response) FDA will allow sufficient time for implementation.
Comments Affecting FDA Forms 3500 and 3500A
    (Comment 1) Section G Field 4 and Section C Field 6: We propose to
add a third checkbox labeled ``unknown'' for when this type of
information is not received. Rationale: This information may not be
received.
    (Response) FDA disagrees. G4 corresponds to ``Date Received by
Manufacturer'' on Form FDA 3500A. This is a required element and the
manufacturer should always have this information. C6 corresponds to Lot
# on the existing Form FDA 3500A. If this information is unknown the
field should be left blank.
    (Comment 2) In Section A1: Along with Patient Identifier, in
bracket (first, last) can be added for better identification.
    (Response) FDA disagrees. Capturing this data may discourage people
from submitting voluntary reports. The instructions for the form state
``Do not use the patient's name or social security number.''
    (Comment 3) In Section A2, Age group can be added.
    (Response) FDA disagrees. The WG believes that the two data
elements proposed for age--Age with checkboxes for days, weeks, months,
years, and date of birth in the format DD-MMM-YYYY are sufficient to
capture this data.
    (Comment 4) In Section A3, after selecting Female, a check box
should populate for pregnancy with options Yes, No, UNK. Pregnancy can
be removed from section B7.

    (Response) FDA disagrees. The Agency believes pregnancy status is
captured sufficiently well through existing field B7.
    (Comment 5) In Section B1, if Product problem check box is selected
then only a text box to enter NDC# should come as National Drug Code is
required ONLY when reporting a drug product problem. It can be removed
from C9.
    (Response) FDA disagrees. Product problem is not limited to drug
products, and may include medical devices, biologics, and other
products which would not have an associated NDC number.
    (Comment 6) In section B2, Hospitalization--initial or prolonged
can be relabeled to only Hospitalization and can have three check
boxes; Initial, Prolonged and Hospital discharge summary available.
Reporter can select whichever is applicable.
    (Response) FDA Disagrees. We encourage reporters to put more detail
about the hospitalization in the narrative text.
    (Comment 7) In section B5, Describe Event or Problem, along with
individual event terms, seriousness criteria for each event should be
populated, so that event-wise seriousness criteria can be identified.
    (Response) FDA disagrees. An event is considered serious if it
meets the regulatory definition, as outlined in Sec. Sec.  310.305,
314.80, 600.80, 803.3, and 1271.
Comments Affecting Form FDA 3500
    None.
Comments Affecting Form FDA 3500A
    (Comment 1) Action taken with drug can be added in section C.
    (Response) FDA disagrees. This information equates to product use
stopped or dose reduced, which is already captured on Forms FDA 3500
and 3500A.
    (Comment 2) We propose that the FDA require medical device adverse
reporting use the MedDRA dictionary instead of the Patient Problem
Codes. Rationale: Currently when reporting adverse events for medical
devices, the current dictionary used is the ``Patient Problem Codes of
the Center for Devices and Radiological Health.'' This dictionary is
much smaller (~800 terms) than the widely used MedDRA dictionary used
when reporting adverse events with drugs (~20.6K terms). Using the
MedDRA dictionary in place of the Patient Problem Codes would allow for
more accurate recording of patient adverse events.
    (Response) FDA disagrees. FDA will continue to use Patient Problem
Codes for medical devices instead of MedDRA coding. While the MedDRA
dictionary is able to adequately capture adverse events with drugs,
patient problem codes and device problem codes are more effective at
capturing device related adverse events.
    (Comment 3) Causality scale can be added in Section C.
    (Response) FDA Disagrees. Causality is not assessed at the
reporting level. Refer to Sec. Sec.  310.305(g), 314.80(k),
600.80(k)(1), and 803.16.
    (Comment 4) In section C10, Concomitant Medical Products and
Therapy Dates (Exclude treatment of event), Dose of concomitant drugs
should also be included.
    (Response) FDA disagrees. Concomitant medical products are not
limited to drug products, and may include medical devices, biologics,
and other regulated products. As concomitant products are not suspected
to be related to the adverse event, it is not necessary to capture the
dose.
    (Comment 5) In Section E1, along with Phone#, Email address can
also be included.
    (Response) FDA disagrees. Form FDA 3500A, section E already
includes a field for email address, as does Forms FDA 3500, section G,
and 3500B. However, we have reviewed the name address field for Forms
FDA 3500 and 3500A and believe data quality would be improved if
separate fields for last name, first name, address, state, ZIP code,
and Country were also included instead of one field labeled ``name and
address'' to capture all of that information.
Comments Affecting Form 3500B
    (Comment 1) One commenter urged the inclusion of a Spanish version
of Form FDA 3500B.
    (Response) FDA agrees with the importance of communicating the
benefits and risks of medical products to healthcare providers and
patients, especially underrepresented populations, including those with
limited English proficiency. FDA's language access plan (http://www.fda.gov/ForConsumers/ByAudience/MinorityHealth/ucm412582.htm)
outlines some of the steps FDA is taking to improve communications with
underrepresented populations. FDA's drug safety communications are
currently translated into Spanish and are available at http://www.fda.gov/Drugs/DrugSafety/ucm263010.htm. FDA is also working to
improve the quality of the data received in adverse event reports
received directly from consumers. At this time, FDA plans to focus
resources on improving data quality from English-language consumer
reports before evaluating how to best handle product experience
information from non-English speaking consumers.
    FDA estimates the burden of this collection of information as
follows:

                                                       Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
      FDA center/21 CFR section/FDA form          Number of     responses per   Total annual         Average  burden per  response             Total
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Center for Biologics Evaluation and Research/
 Center for Drug Evaluation and Research:
    Form FDA 3500............................          14,727               1          14,727  0.66 (40 minutes)........................           9,720
    Form FDA 3500A (Sec.  Sec.   310.305,                 599              98          58,702  1.21.....................................          71,029
     314.80, 314.98, 600.80, 1271.350).
    Form FDA 3500A (Sec.   310.305                         50               2             100  1.21.....................................             121
     outsourcing facilities).
Center for Devices and Radiological Health:
    Form FDA 3500............................           5,233               1           5,233  0.66 (40 minutes)........................           3,454
    Form 3500A (Sec.   803)..................           2,277             296         673,992  1.21.....................................         815,530
Center for Food Safety and Applied Nutrition:
    Form FDA 3500............................           1,793               1           1,793  0.66 (40 minutes)........................           1,183
    Form 3500A...............................           1,659               1           1,659  1.21.....................................           2,007
Center for Tobacco Products Form FDA 3500....              39               1              39  0.66 (40 minutes)........................              26

All Centers Form FDA 3500B...................          13,750               1          13,750  0.46 (30 minutes)........................           6,325
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................         909,395
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Dated: May 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13102 Filed 5-29-15; 8:45 am]
 BILLING CODE 4164-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D. C., 20460 April 13, 2006 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM SUBJECT: Qualitative impact assessment of extensions to restricted entry intervals for phosmet in apricots ( DP # 296575)

FROM: Angel Chiri, Entomologist Biological Analysis Branch T J Wyatt, Agricultural Economist Economic Analysis Branch Biological and Economic Analysis Division ( 7503C)

THRU: Arnet Jones, Chief Biological Analysis Branch Tim Kiely, Acting Chief Economic Analysis Branch Biological and Economic Analysis Division ( 7503C)

TO: Diane Isbell, Chemical Review Manager Margaret Rice, Chief Special Review and Reregistration Division Product Review Panel: April 5, 2006 Summary EPA is considering mitigation strategies to address concerns for workers exposed to phosmet following applications to apricot orchards. This is a preliminary, qualitative assessment of the impact of extending the restricted entry interval ( REI).

A REI greater than seven days would interfere with crop production practices, such as propping, although the REI for hand harvest could be extended to 14 days to match the pre harvest 2 interval. If a longer REI is imposed, growers would have to replace phosmet with one or more of several available alternatives. BEAD tentatively concludes that no yield or quality losses are likely if growers switch to an alternative. Production costs would likely increase because alternatives are more costly, would have to be applied more often, or would result in applications of additional pesticides to control secondary pests. However, given the low usage of phosmet, these impacts may be minor and would not affect a large number of growers.

Background Based on post application worker risk assessments, EPA is considering mitigation strategies, including extending the REI for phosmet use on apricots. The risk assessment indicates that an REI of 24 days would be necessary to reduce risks to worker below the Agency's level of concern. The purpose of this assessment is to provide a preliminary, qualitative assessment of the impact of this strategy on apricot producers and the apricot industry.

Apricots The most recent statistics indicate that about 16,000 acres of apricots are grown in the US ( USDA NASS, 2006). Over 90% of the acreage is in California. Utah and Washington are the other main producing states. Acreage has been declining since the late 1990' s, but average yields have increased to almost five tons per acre. Production has been fairly stable, at about 80,000 tons annually with a total value of about $ 33.1 million. Producer prices are around $ 350/ ton in California, but are much higher in other regions of the country.

Recent Use of Phosmet According to data from the California Pesticide Use Reports, phosmet use on apricots declined rapidly between 1999 and 2002, from over 18% to about 5% of the crop treated ( CDFA, various years). Use has remained at about 5% for the past several years. The decline in phosmet use seems to be due to growers shifting to alternatives because of concerns about OP runoff in orchards ( Pest Management Strategic Plan for Peach Production in California, 2003). There is typically a single application per year, but there may be as many as three.

Maximum Feasible REIs The 2001 BEAD assessment concluded that extending the REI for hand harvesting to 14 days, equivalent to the pre harvest interval ( PHI), would not result in grower impacts. However, within the season, the maximum REI that would not interfere with orchard activities is around seven days ( Atwood and Alsadek, 2001). In particular, apricots must often be propped to prevent limb breakage through the growing season as fruit size increases. Extension of the phosmet REI beyond seven days would interfere with this practice, possibly resulting in limb breakage, tree injury, and fruit loss. 3 Impacts of Extending the REI Extending the REI beyond the seven days for activities other than hand harvesting, such as propping for late varieties, would result in growers shifting to one of several available alternatives for control of pests targeted by phosmet. These pests include the fruit tree leafroller, green fruitworm, Oriental fruit moth, and peach twig borer.

Phosmet is a broad spectrum insecticide and may be controlling a number of secondary insects that BEAD has not identified. Use of alternatives that have a more narrow range of activity may result in populations of these pests increasing to damaging levels.

Alternatives Alternatives for control of pests targeted by phosmet are:   diazinon and malathion ( organophosphates);   carbaryl ( carbamate);   endosulfan ( organochlorine);   cyfluthrin, esfenvalerate, lambda cyhalothrin, and gamma cyhalothrin ( synthetic pyrethroids);   diflubenzuron, methoxyfenozide, and pyriproxyfen ( insect growth regulators);   spinosad ( actinomycete derivative);   Bacillus thuringiensis ( biopesticide); and   mating disruption ( pheromones).

Several of these alternatives provide control over most or all of the pests controlled by phosmet. Table 1 indicates the chemicals that are registered for use against the various pests and their typical cost per acre. However, these alternatives may not be as efficacious as phosmet and could require more than one application to achieve the same level of control. Cost may be indicative of relative efficacy and phosmet is one of the more expensive means of control. This may also explain the relatively low usage. It may be that growers who use phosmet face relatively higher pest pressure than those who use a less expensive insecticide. If the same control cannot be achieved with phosmet alternatives, growers may experience yield and/ or quality losses. 4 Table 1. Registered alternatives and efficacy ratings for phosmet target pests Fruit tree leafroller Green fruitworm Oriental fruit moth4 Peach twig borer4 Cost 1 $/ acre phosmet E x G E G 22.80 diazinon G x G G E 11.50 carbaryl F x G G 14.27 endosulfan 2 P P F G cyfluthrin 2 x x x gamma cyhalothrin 2 x x x lambda cyhalothrin E x 9.60 esfenvalerate P x G G E 7.50 diflubenzuron x x x 20.40 methoxyfenozide x x x x 16.50 pyriproxyfen 2 x x spinosad x x x x 27.50 Bacillus thuringiensis F G x P G E 9.70 mating disruption 3 P E F Source: UC Pest Management Guidelines ( 2006), Pest Management Strategic Plan for Nectarine Production in California ( 2003), Pest Management for Strategic Plan for Peach Production in California ( 2003), Atwood and Alsadek ( 2001), and CDMS data ( Efficacy ratings: E = excellent, G = good, F = fair, P = poor, x = efficacy status unclear). 1 EPA proprietary data, based on California treatment costs for target pests, 2001 2004 average. 2 Insufficient usage from which to calculate cost. 3 EPA data do not include the cost of pheromones.

A simple comparison of costs may not be the only factor in selecting a pesticide. Some of the alternatives, such as pyrethroids, are less compatible with integrated pest management ( IPM) and mating disruption programs than is phosmet. Pyrethroids often precipitate secondary pests outbreaks, such as spider mites, and cause growers to resort to the use of miticides, which may cost over $ 50 per acre.

In addition, extension of the REI for hand harvesting beyond 14 days may lead to prophylactic insecticide applications to ensure crop protection prior to harvest.

In recent years, broad spectrum insecticides, such as organophosphates, are being replaced by insecticides with a narrower activity spectrum. The older chemicals not only controlled the target pest( s), but also, most other exposed insects. A consequence of the shift to newer chemistries is that crop damage from insects that until recently were considered minor pests appears to be increasing. However, concomitantly the shift to narrower spectrum chemicals may result in less mortality for beneficial species, including natural enemies, which should in turn increase natural mortality for some insect pests, ultimately leading to less pesticide use. To the extent that these pest dynamics continue to evolve and remain rather difficult to predict, this analysis examines only potential short term ( two to three years) impacts.

Impacts Because a REI for phosmet beyond seven days ( or 14 days prior to harvest) would interfere with some crop production practices, such as propping for late varieties, growers would likely stop 5 using it and turn to one or more of several available alternatives ( Atwood and Alsadek, 2001). Based on recent low usage of phosmet and the availability of new alternatives, BEAD tentatively concludes that yield or quality losses are unlikely if phosmet could not be used. It is likely that production costs will increase because some alternatives are more costly, would have to be applied more often, or would result in applications of additional pesticides to control secondary pests. However, given the low usage of phosmet, these losses may be minor and would not affect a large number of growers.

Request for Additional Information As part of the request for comments, BEAD would welcome data that could be used to refine this assessment if necessary. Useful information would include:

  usage information for states other than California;   particular regional or pest problems leading to phosmet use;   comparative product performance data, including yield and quality impacts;   relative product costs;   non chemical alternatives, efficacy and cost; and   restrictions or other constraints on the use of alternatives.

References A Pest Management Strategic Plan for Nectarine Production in California. 2003. http:// www. ipmcenters. org/ pmsp/ pmsp_ form. cfm? usdaregion= National% 20Site A Pest Management Strategic Plan for Peach production in California. 2003. http:// www. ipmcenters. org/ pmsp/ pmsp_ form. cfm? usdaregion= National% 20Site Atwood, D. and J. Alsadek. 2001. Initial Apricot Benefits Assessment for Phosmet. Unpublished EPA report.

CDFA ( California Dept. of Food and Agriculture). various years. Usage of Agricultural Pesticides in California: Pesticide Usage Report. California Department of Food and Agriculture, Sacramento, at http:// www. ipm. ucdavis. edu/ PUSE/ puse1. html .

Crop Data Management System. 2006. ChemSearch Database.

UC Pest Management Guidelines. 2006. Apricot. University of California, Statewide Integrated Pest Management USDA NASS. 2006. Noncitrus Fruits and Nuts, 2005 Preliminary Summary. National Agricultural Statistics Service, U. S. Department of Agriculture, January, at http:// usda. mannlib. cornell. edu/ reports/ nassr/ fruit/ pnf bb/ ncit0106. pdf.


[Federal Register Volume 81, Number 94 (Monday, May 16, 2016)]
[Notices]
[Pages 30293-30294]
[FR Doc No: 2016-11518]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC16-101-000.
    Applicants: White Pine Solar, LLC, White Oak Solar, LLC.
    Description: Revisions to April 13, 2016 Application for
Authorization Under Section 203 of the Federal Power Act and Request
for Shortened Comment Period of White Pine Solar, LLC, et al.
    Filed Date: 5/5/16.
    Accession Number: 20160505-5273.
    Comments Due: 5 p.m. ET 5/16/16.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-1586-005; ER12-2511-008; ER10-1596-004; ER11-
1936-004; ER10-1630-005.
    Applicants: Big Sandy Peaker Plant, LLC, C.P. Crane LLC, High
Desert Power Project, LLC, TPF Generation Holdings, LLC, Wolf Hills
Energy, LLC.
    Description: Notification of Change in Status of Big Sandy Peaker
Plant, LLC, et al.
    Filed Date: 5/9/16.
    Accession Number: 20160509-5204.
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    Docket Numbers: ER10-2881-024; ER10-2641-024; ER10-2663-024; ER10-
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ER13-1101-019; ER13-1541-018; ER14-661-010; ER14-787-012; ER15-54-004;
ER15-55-004; ER15-647-002; ER15-1475-005; ER15-2191-001; ER15-2593-004;
ER16-452-004; ER16-705-002; ER16-706-002.
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Southern Turner Cimarron I, LLC, Spectrum Nevada Solar, LLC, Campo
Verde Solar, LLC,

SG2 Imperial Valley LLC, Macho Springs Solar, LLC, Lost Hills Solar,
LLC, Blackwell Solar, LLC, Kay Wind, LLC, North Star Solar, LLC, Grant
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RE Garland A LLC.
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effective date of June 1, 2016, et al.
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effective date of June 1, 2016, et al.
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requirements, interventions, protests, service, and qualifying
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(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: May 10, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-11518 Filed 5-13-16; 8:45 am]
 BILLING CODE 6717-01-P


Scott,

Hate to keep bugging you.  How's the cost info coming (see below)?  Any cost info will be public information and placed in the docket.  Thanks

John Schakenbach

U.S. Environmental Protection Agency

Clean Air Markets Division

  HYPERLINK<EMAIL_ADDRESS>\t "_blank"  <EMAIL_ADDRESS> Phone:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>

-----Forwarded by John Schakenbach/DC/USEPA/US on 08/18/2010 03:56PM -----

To<EMAIL_ADDRESS> From: John Schakenbach/DC/USEPA/US

Date: 08/10/2010 08:06AM

Subject: Fw: Request for Cost Information

Scott,

Louis Nichols said he talked with you at CIBO.  Welcome back.  Any luck with the cost info (see below) to help me address some cost comments on the proposed rule?.

John Schakenbach

U.S. Environmental Protection Agency

Clean Air Markets Division

<EMAIL_ADDRESS> Phone:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>

----- Forwarded by John Schakenbach/DC/USEPA/US  on 08/10/2010 08:04 AM  -----

From:

John Schakenbach/DC/USEPA/US

To:

<EMAIL_ADDRESS>

Date:

08/05/2010 09:12 AM

Subject:

Scott,

I'm writing the response to comments document for the AETB and PGVP proposed rule.  There are a number of comments related to cost.  It would help me a lot if you could provide a cost estimate for each of the following, which is a direct quote from a commenter:

"(1) the cost of staff time to develop and implement the quality manual required by the ASTM practice, including document control procedures, hiring of additional personnel, performance of annual audits, and documentation of corrective action;

(2) application fees and the cost of preparing applications for accreditation and/or QI qualification;

(3) the cost of QI exams, including tuition for preparatory courses, exam fees, and travel expenses;

(4) any new costs associated with preparation of test plans and reports to comply with the specific criteria in the practice; and

(5) cost of required records storage and backup. While the costs may turn out to be reasonable and EPA may be of the view that AETBs already should be operating in a manner consistent with the ASTM practice, that view is not a justification for excluding those costs from the ICR."

Thanks

John Schakenbach

U.S. Environmental Protection Agency

Clean Air Markets Division

  HYPERLINK<EMAIL_ADDRESS>\t "_blank"  <EMAIL_ADDRESS>

Phone:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>