[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