Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices 73591 

Initial Consultations 

Initial consultations are generally a 

one-time burden, although a developer 

might return more than once to discuss 

additional issues before submitting a 

final consultation. As noted in the 

guidance, FDA encourages developers to 

consult early in the development phase 

of their products, and as often as 

necessary. Historically, firms 

developing a new bioengineered plant 

variety intended for food use have 

generally initiated consultation with 

FDA early in the process of developing 

such a variety, even though there is no 

legal obligation for such consultation. 

These consultations have served to 

make FDA aware of foods and food 

ingredients before these products are 

distributed commercially, and have 

provided FDA with the information 

necessary to address any potential 

questions regarding the safety, labeling, 

or regulatory status of the food or food 

ingredient. As such, these consultations 

have provided assistance to both 

industry and the Agency in exercising 

their mutual responsibilities under the 

FD&C Act. 

FDA estimates that its Center for 

Veterinary Medicine (CVM) and its 

Center for Food Safety and Applied 

Nutrition (CFSAN) jointly received an 

average of 40 initial consultations per 

year in the last 3 years via telephone, 

email or written letter. Based on this 

information, we expect to receive no 

more than 40 annually in the next 3 

years. 

Final Consultations 

Final consultations are a one-time 

burden. At some stage in the process of 

research and development, a developer 

will have accumulated the information 

that the developer believes is adequate 

to ensure that food derived from the 

new plant variety is safe and that it 

demonstrates compliance with the 

relevant provisions of the FD&C Act. 

The developer will then be in a position 

to conclude any ongoing consultation 

with FDA. The developer submits to 

FDA a summary of the safety and 

nutritional assessment that has been 

conducted about the bioengineered food 

that is intended to be introduced into 

commercial distribution. FDA evaluates 

the submission to ensure that all 

potential safety and regulatory questions 

have been addressed. FDA has 

developed a form that prompts a 

developer to include certain elements in 

the final consultation in a standard 

format: Form FDA 3665 entitled, ‘‘Final 

Consultation for Food Derived From a 

New Plant Variety (Biotechnology Final 

Consultation).’’ The form, and elements 

that would be prepared as attachments 

to the form, can be submitted in 

electronic format. 

Upon implementation of the 

collection, FDA contacted five firms that 

had made one or more biotechnology 

consultation submissions. We asked 

each of these firms for an estimate of the 

hourly burden to prepare a submission 

under the voluntary biotechnology 

consultation process. Based on 

information provided by the three firms 

who responded, we estimate the average 

time to prepare a submission for final 

consultation to be 150 hours. 

Dated: December 8, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29046 Filed 12–10–14; 8:45 am] 

BILLING CODE 4164–01–P 

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. 

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, PRAStaff@

fda.hhs.gov. 

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 

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73592 Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices 

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 §§ 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 tissuebased 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 devicerelated 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/About

FDA/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. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices 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 directto-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/ReportsManuals

Forms/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.safety

reporting.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//). Paperbased dietary supplement reports may 

be submitted using Form FDA 3500A. 

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73594 Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices 

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 dataentry 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/Regulatory

Information/Legislation/FederalFood

DrugandCosmeticActFDCAct/

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 § 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-theCounter? (Check all that apply)’’ with 

corresponding checkboxes for 

‘‘Compounded’’ and ‘‘Over-TheCounter’’ (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 selfaddressed, 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 dataentry 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/FederalFoodDrug

andCosmeticActFDCAct/Significant

AmendmentstotheFDCAct/FDASIA/

UCM410474.pdf) developed in response 

to the requirement in section 907 of 

FDASIA, changes are proposed to the 

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Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices 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 § 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-theCounter (Check all that apply)?’’ with 

corresponding checkboxes for 

‘‘Compounded’’ and ‘‘Over-TheCounter’’ (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/FederalFoodDrugand

CosmeticActFDCAct/Significant

AmendmentstotheFDCAct/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-TheCounter (Check all that apply)’’? and 

corresponding checkboxes for 

‘‘Compounded’’ and ‘‘Over-TheCounter.’’ 

Finally, to improve clarity and to be 

consistent with Form FDA 3500, FDA 

proposes to reword the last field of 

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73596 Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices 

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

FDA Center/21 CFR section/FDA form Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total 

Center for Biologics Evaluation and Research/

Center for Drug Evaluationand Research:.

Form 3500 ..................................................... 14,727 1 14,727 0.66 (40 minutes) ......... 9,720 

Form 3500A (§§ 310.305, 314.80, 314.98, 

600.80, 1271.350).

599 98 58,702 1.21 ............................... 71,029 

Center for Devices and Radiological Health:.

Form 3500 ..................................................... 5,233 1 5,233 0.66 (40 minutes) ......... 3,454 

Form 3500A (§ 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 minutes) ......... 1,183 

Form 3500A ................................................... 1,659 1 1,659 1.21 ............................... 2,007 

Center for Tobacco Products.

Form 3500 ..................................................... 39 1 39 0.66 (40 minutes) ......... 26 

All Centers.

Form 3500B ................................................... 13,750 1 13,750 0.46 (30 minutes) ......... 6,325 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–2076] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Survey on the 

Occurrence of Foodborne Illness Risk 

Factors in Selected Restaurant Facility 

Types 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

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 

a survey entitled, ‘‘Occurrence of 

Foodborne Illness Risk Factors in 

Selected Restaurant Facility Types 

(2013–2022).’’ 

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, PRAStaff@

fda.hhs.gov. 

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. 

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