[Federal Register Volume 80, Number 104 (Monday, June 1, 2015)]
[Notices]
[Pages 31042-31048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 202-395-7285, or emailed to [email protected]. 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 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 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

[[Page 31043]]

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

[[Page 31044]]

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,''

[[Page 31045]]

``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

[[Page 31046]]

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.

[[Page 31047]]

    (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

[[Page 31048]]

 
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