[Federal Register Volume 79, Number 238 (Thursday, December 11, 2014)]
[Notices]
[Pages 73591-73596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29064]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1960]
Agency Information Collection Activities; Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on revisions to Forms FDA 3500,
3500A, and 3500B used in the FDA Medical Products Reporting Program.
DATES: Submit either electronic or written comments on the collection
of information by February 9, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, [email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
MedWatch: The FDA Medical Products Reporting Program--(OMB Control
Number 0910-0291)--Extension
I. Background
To ensure the marketing of safe and effective products,
postmarketing adverse outcomes and product problems must be reported
for all FDA-regulated human healthcare products, including drugs
(prescription, nonprescription, and compounded), biologics, medical
devices, dietary supplements and other special nutritional products
(e.g. infant formula and medical foods), and cosmetics. In addition,
FDA has
[[Page 73592]]
regulatory responsibility for some tobacco products and an interest in
receiving reports about adverse outcomes and product problems for these
products.
Under sections 505, 512, 513, 515, 519, and 903 of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act), (21 U.S.C. 355, 360b,
360c, 360e, 360i, and 393), and section 351 of the Public Health
Service Act (42 U.S.C. 262), FDA has the responsibility to ensure the
safety and effectiveness of drugs, biologics, and devices. Under
section 502(a) of the FD&C Act (21 U.S.C. 352(f)(2)), a drug or device
is misbranded if its labeling is false or misleading. Under section
502(f)(1) of the FD&C Act, it is misbranded if it fails to bear
adequate warnings, and under section 502(j), it is misbranded if it is
dangerous to health when used as directed in its labeling. Under
section 502(t)(2) of the FD&C Act, devices are considered to be
misbranded if there has been a failure or refusal to give required
notification or to furnish required material or information required
under section 519 of the FD&C Act. Requirements regarding mandatory
reporting of adverse events or product problems have been codified in
parts 310, 314, 600, and 803 of the FD&C Act (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 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.
FDA regulates the safety (i.e., adulteration) of dietary
supplements under section 402 of the FD&C Act (21 U.S.C. 342). Dietary
supplements do not require premarket approval by FDA, and the Agency
bears the burden to gather and review evidence that a dietary
supplement may be adulterated under section 402 of the FD&C Act after
that product is marketed. Under section 761(b)(1) of the FD&C Act (21
U.S.C 379aa-1(b)(1)), 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.
Since 1993, mandatory adverse event reporting has been supplemented
by voluntary reporting by healthcare professionals, their patients, and
consumers via the MedWatch reporting process. To carry out its
responsibilities, the Agency needs to be informed when an adverse
event, product problem, error with use of a human medical product, or
evidence of therapeutic failure is suspected or identified in clinical
use. 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.
To implement these provisions for 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 may 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 may 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).
Respondents to this collection of information are healthcare
professionals; medical care organizations and other user facilities
(e.g. extended care facilities, ambulatory surgical centers);
consumers; manufacturers of biological, dietary supplement and drug
products, or medical devices; and importers.
II. Use of Form FDA 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 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 (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 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 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.
[[Page 73593]]
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
(Ref. 1), 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 Reporting)
A. Drug and Biological Products
In sections 503B, 505(j), and 704 (21 U.S.C. 374) of the FD&C Act,
Congress has required that important safety information relating to all
human prescription 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 (biologics).
Mandatory reporting of adverse reactions for HCT/Ps has been codified
in 21 CFR 1271.350. Postmarketing Safety Reports--Changes in Format
Starting in 2015
Current requirements specify that postmarket adverse experience
reports must be submitted on paper on FDA Form 3500A (or the CIOMS
(Council for International Organizations of Medical Sciences) I form)
for serious, unexpected adverse experiences from a foreign source), but
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 postmarket safety reports,
including individual case safety reports. Entities with mandatory
reporting obligations must implement this rule within 1 year of the
issuance date (by June 9, 2015). For more information see: http://www.gpo.gov/fdsys/pkg/FR-2014-06-10/pdf/2014-13480.pdf.
B. 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 21 CFR part 803 (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 reprocessor and whether the device has been reused.
C. Nonprescription Drug Products and Dietary Supplements
Section 502(x) in the FD&C Act (21 U.S.C. 352(x)) implements the
requirements of the Dietary Supplement and Nonprescription Drug
Consumer Protection Act (Pub. L. 109-462), which became law on December
22, 2006. These requirements apply to manufacturers, packers, and
distributors of nonprescription OTC human drug products marketed
without an approved application. The law requires reports of serious
adverse events to be submitted to FDA by manufacturers of dietary
supplements. Electronic reports for dietary supplements may be
submitted using the Safety Reporting Portal (http://www.safetyreporting.hhs.gov//). Paper-based dietary supplement reports
may be submitted using Form FDA 3500A.
[[Page 73594]]
V. Proposed Modifications to Existing Forms 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. First, it is proposed that sections C, ``Product
Availability,'' and D, ``Suspect Product(s),'' on the current form be
merged into a single section to be entitled section C, ``Suspect
Products.'' In the new section C, field C1will be used to request data
for ``Name and Strength,'' ``Manufacturer/Compounder,'' ``Lot #,'' and
``NDC # or Unique ID #'' for up to two suspect medical products. Fields
for ``Lot #'' and ``NDC # or Unique ID #'' on the current form (D6 and
D9) will be removed on the proposed form. The single field for
``Product Availability'' (section C on the current form) will be
relocated to C2 on the proposed form, immediately following the field
for product name, strength, manufacturer/compounder, Lot #, and NDC/
Unique ID #. As a result of sections C and D being merged, the
remaining sections on the form will be resequenced accordingly (i.e.
section E currently labeled ``Suspect Medical Device'' will become
section D with the same label, section F will become section E, and
section G will become section F).
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 ``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 Product Compounded
or Over-the-Counter? (Check all that apply)'' with corresponding
checkboxes for ``Compounded'' and ``Over-The-Counter'' (for up to two
suspect products). 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
[[Page 73595]]
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 be
removed. It is also proposed that a new field be added, numbered C2,
and containing the descriptor ``Product Available for Evaluation?''
with checkboxes for ``Yes,'' ``No,'' and ``Returned to Manufacturer on
(DD-MMM-YYYY).'' Consequently, 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 C8, and
field C8, ``Event Reappeared After Reintroduction?'' will be renumbered
C9. Field C7 remains a field for expiration date, and field C10 will
remain a field for concomitant medical products and therapy dates.
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 Product
Compounded or Over-the-Counter (Check all that apply)?'' with
corresponding checkboxes for ``Compounded'' and ``Over-The-Counter''
(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 (Pub. L. 112-144). 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, section 503B of the FD&C
Act requires outsourcing facilities to report adverse events to FDA. 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 Forms FDA 3500 and 3500B to improve the ability to rapidly
identify reports involving compounded drugs. FDA proposes to add a
field to section B with the label ``Is product Compounded or Over-The-
Counter (Check all that apply)''? and corresponding checkboxes for
``Compounded'' and ``Over-The-Counter.''
Finally, to improve clarity and to be consistent with Form FDA
3500, FDA proposes to reword the last field of
[[Page 73596]]
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.''
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 Number of responses per Total annual Average burden Total
form respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Center for Biologics
Evaluation and Research/
Center for Drug Evaluationand
Research:.
Form 3500................. 14,727 1 14,727 0.66 (40 9,720
minutes).
Form 3500A (Sec. Sec. 599 98 58,702 1.21............ 71,029
310.305, 314.80, 314.98,
600.80, 1271.350).
Center for Devices and
Radiological Health:.
Form 3500................. 5,233 1 5,233 0.66 (40 3,454
minutes).
Form 3500A (Sec. 803)... 2,277 296 673,992 1.21............ 815,530
Center for Food Safety and
Applied Nutrition:.
Form 3500................. 1,793 1 1,793 0.66 (40 1,183
minutes).
Form 3500A................ 1,659 1 1,659 1.21............ 2,007
Center for Tobacco Products...
Form 3500................. 39 1 39 0.66 (40 26
minutes).
All Centers...................
Form 3500B................ 13,750 1 13,750 0.46 (30 6,325
minutes).
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 909,274
----------------------------------------------------------------------------------------------------------------
VI. References
1. Kessler, D. A, ``Introducing MEDWatch: A New Approach to
Reporting Medication and Device Adverse Effects and Product
Problems,'' Journal of the American Medical Association, 269(21),
June 2, 1993, pp. 2765-2768.
Dated: December 5, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29064 Filed 12-10-14; 8:45 am]
BILLING CODE 4164-01-P