46166 Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices 

312.32, 312.38, 312.55, and 312.56 have 

been approved under OMB control 

number 0910–0014; 21 CFR 314.50 has 

been approved under OMB control 

number 0910–0001; and 21 CFR 812.35 

and 812.150 have been approved under 

OMB control number 0910–0078. 

In the Federal Register of May 31, 

2018 (83 FR 25015), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

We estimate the burden of the 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Section of guidance/reporting activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

5. Sponsor reporting to FDA on DMC recommendations related to safety.37 1 37 0.50 (30 minutes) .. 18.5 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Section of guidance/recordkeeping activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

responses 

Average 

burden per 

recordkeeping 

Total hours 

4.1. and 6.4 SOPs for DMCs ....................................... 37 1 37 8 296 

4.4.3.2. DMC meeting records ..................................... 370 1 370 2 740 

Total ...................................................................... ........................ ........................ ........................ ................................ 1,036 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Section of guidance/disclosure activity Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average burden 

per disclosure Total hours 

4.4.1.2. Sponsor notification to the DMC regarding 

waivers.

1 1 1 0.25 (15 minutes) ... 0.25 

4.4.3.2. DMC reports of meeting minutes to the sponsor.370 2 740 1 ............................. 740 

Total ...................................................................... ........................ ........................ ........................ ................................ 740.25 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: September 6, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19799 Filed 9–11–18; 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; 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. 

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 October 12, 

2018. 

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 oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0291 and 

title ‘‘MedWatch: The Food and Drug 

Administration Medical Products 

Reporting Program.’’ Also include the 

FDA docket number found in brackets 

in the heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

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— 

Revision 

This information collection supports 

FDA’s MedWatch safety information 

and adverse event reporting program. 

Members of the public use FDA’s 

MedWatch system to report adverse 

events, product problems, errors with 

the use of a human medical product, or 

when evidence of therapeutic failure is 

suspected or identified in clinical use. 


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Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices 46167 

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, we have developed 

three forms (collectively known as the 

MedWatch forms). Form FDA 3500 is 

intended to be used for voluntary (i.e., 

not mandated by law or regulation) 

reporting by healthcare professionals; 

Form FDA 3500A is used for mandatory 

reporting (i.e., required by law or 

regulation); and 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). Information 

collected by the forms is used to assess 

and evaluate risks associated with FDAregulated products, enabling us to take 

appropriate action to reduce, mitigate, 

or eliminate the public’s exposure to the 

risk through regulatory and public 

health interventions. 

I. Background 

A. Authorizing Statutes and Codified 

Regulations 

The Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (21 U.S.C. 353b, 355, 

360i, 360l, and 393) and the Public 

Health Service Act (42 U.S.C. 262) 

require FDA to collect mandatory 

adverse event reports from regulated 

industry on medical products once they 

have been approved for marketing, 

enabling the Agency to monitor the 

safety of drugs, biologics, medical 

devices, and dietary supplements. 

Postmarket reporting for medical foods, 

infant formula, cosmetics, and tobacco 

products is done voluntarily. 

Requirements regarding mandatory 

reporting of adverse events or product 

problems are codified at parts 310, 314, 

600, and 803 (21 CFR parts 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 (21 

U.S.C. 353b, 379aa, and 379aa–1). 

Mandatory reporting of adverse 

reactions for human cells, tissues, and 

cellular- and tissue-based products 

(HCT/Ps) is codified at § 1271.350 (21 

CFR 1271.350). 

B. Voluntary Reporting: Form FDA 3500 

Voluntary reporting of adverse events 

is completed using Form FDA 3500 and 

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 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, which is 

jointly administered by FDA and the 

Centers for Disease Control and 

Prevention and approved under OMB 

control number 0910–0308. 

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 (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 

(https://www.safetyreporting.hhs.gov/ 

approved under OMB control number 

0910–0645). 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 

https://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 (overthe-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 (https://

www.safetyreporting.hhs.gov/). 

C. Mandatory Reporting: Form FDA 

3500A 

1. Drug and Biological Products 

In sections 505(b) and (j), 503B, and 

704 (21 U.S.C. 355(b) and (j), 353B, and 

374) of the FD&C Act, Congress has 

required that important safety 

information relating to all human drug 

products be made available to 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 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 § 1271.350. 

2. OTC Monograph Drug Products and 

Dietary Supplements 

Section 760 of the FD&C Act provides 

for mandatory safety reporting for nonprescription 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. 


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3. Postmarketing Safety Reports— 

Changes in Format Starting in June 2018 

Current requirements specify that 

postmarketing adverse experience 

reports must be submitted on paper on 

Form FDA 3500A (or the CIOMS) 

(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 see: https://

www.gpo.gov/fdsys/pkg/FR-2014-06-10/ 

pdf/2014-13480.pdf. 

4. 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 reprocessor and whether the 

device has been reused. 

D. Voluntary Reporting by Consumers: 

Form FDA 3500B 

Form FDA 3500B was developed for 

voluntary reporting 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 

and healthcare professionals of 

suspected serious adverse outcomes and 

other product problems associated with 

human medical products, (https://

www.fda.gov/Safety/ReportaProblem/ 

default.htm). 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 of 2007 (Pub. L. 110– 

85) amended section 502(n) of the FD&C 

Act (21 U.S.C. 352(n)) 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 

https://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. For this reporting FDA has 

created Form FDA 3500B, a modified 

version of Form FDA 3500 tailored for 

consumers and written in plain 

language (in conformance with the Plain 

Writing Act of 2010 (Pub. L. 111–274), 

https://www.gpo.gov/fdsys/pkg/PLAW111publ274/pdf/PLAW111publ274.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 https://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/, approved under 

OMB control number 0910–0645). 

Reporting is supported for drugs, nonvaccine 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 (https://

www.safetyreporting.hhs.gov/, approved 

under OMB control number 0910–0645). 

II. Proposed Modification to Existing 

Forms FDA 3500, 3500A, and 3500B 

A. General Changes 

The proposed modifications to Form 

FDA 3500 and Form FDA 3500A reflect 

changes that will bring the form into 

conformity, since the previous OMB 

authorization in 2015, with current 

regulations, rules, and guidances and 

fall into three categories: (1) Regulatory 

driven revisions, (2) work 

improvements for the Center, and (3) 

report processing improvements. We 

also welcome comments about 

translation of Form FDA 3500B 

(consumer) into Spanish and other 

languages. Lastly, formatting 

modifications are being proposed to 

several fields to enhance the quality, 

utility, and clarity of the information. 

B. Changes Proposed for Form FDA 

3500 

In section A, we are revising the 

heading of A3 to ‘‘Current Gender’’ 

followed by check boxes next to the 

following options ‘‘Female’’, ‘‘Male’’, 

‘‘Intersex’’, ‘‘Transgender’’, ‘‘Prefer not 

to disclose.’’ 

In section B, we are revising B1 to 

‘‘Type of Report (check all that apply)’’. 

In section B2, we are removing 

‘‘(Devices)’’ from the last option. We are 

also splitting section B6 into two 


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questions: ‘‘B6.a. Relevant Test (please 

included dates)’’ and ‘‘B6.b. Relevant 

Laboratory Data (please included 

dates).’’ 

In section C, we are adding question 

C2 ‘‘Do you have a picture of the 

product?’’ 

In section D1, we are adding the 

question ‘‘Does this report involve 

cosmetics, dietary supplements or 

food?’’ followed by a checkbox for 

‘‘Yes.’’ In section D4, we are adding the 

question ‘‘Is therapy still on-going?’’ 

This question is important for 

pharmacovigilance and the current form 

does not allow the reporter to be 

specific. The current form does not 

allow the reporter to be specific. It is 

proposed to combine boxes D6 and D7 

and change the title to ‘‘Product Type’’ 

(check all that apply). 

In section E, we are adding question 

E9 ‘‘Was this device serviced by a thirdparty servicer?’’ followed by a checkbox 

for ‘‘Yes’’ and a checkbox for ‘‘No.’’ 

C. Changes Proposed for Form FDA 

3500A 

In section A, we are revising the 

heading of A3 to ‘‘Current Gender’’ 

followed by check boxes next to the 

options ‘‘Female’’, ‘‘Male’’, ‘‘Intersex’’, 

‘‘Transgender’’, ‘‘Prefer not to disclose’’. 

In section B, we are revising the 

heading for BI to now read ‘‘Type of 

Report (check all that apply)’’. In section 

B2, we are removing ‘‘(Devices)’’ from 

the last option. Section B6 is being split 

into two questions: ‘‘B6.a. Relevant Test 

(please include dates)’’ and ‘‘B6.b. 

Relevant Laboratory Data (please 

include dates),’’ 

In section C, we are combining boxes 

C6 and C7 and changing the title to 

‘‘Product Type’’ (check all that apply). 

In section D, we are adding a new 

question ‘‘Was this device serviced by a 

third party?’’ followed by a checkbox for 

‘‘Yes’’ and a checkbox for ‘‘No.’’ 

In section F, we are changing the 

revising the heading of F10 to ‘‘Adverse 

Event Problem’’ and splitting the 

‘‘Patient Code’’ box into two fields 

entitled ‘‘Patient Outcome Code’’ and 

‘‘Patient Severity Code.’’ We are also 

splitting the ‘‘Device Code’’ field into 

two fields entitled ‘‘Device Code’’ and 

‘‘Component Code.’’ 

In section G, question G1 will now 

include ‘‘or Compounding Outsourcing 

Facility’’ after (and Manufacturing Site 

for Devices.)’’ In section G5, we are 

adding two new options entitled 

‘‘PreANDA’’ and ‘‘Compounded 

Product’’ followed by a check box for 

‘‘Yes,’’ and making consistent changes 

within section G6 by replacing ‘‘If IND,’’ 

to ‘‘Give Protocol #.’’ 

In section H1, we are adding a check 

box to indicate whether a summary 

report is included followed by a field in 

which to indicate ‘‘Number of Events 

Summarized’’ and an open field in 

which to add text. We are renaming 

section H6 to ‘‘Adverse Event Problem’’ 

and splitting ‘‘Patient Code’’ into two 

fields entitled ‘‘Patient Outcome Code’’ 

and ‘‘Patient Severity Code.’’ We are 

also splitting ‘‘Device Code’’ into two 

fields entitled ‘‘Device Code’’ and 

‘‘Component Code.’’ In section H6, we 

are renaming the headings as follows: 

(1) ‘‘Method’’ to ‘‘Type of Investigation’’ 

(2) ‘‘Results’’ to ‘‘Investigation 

Findings’’ and (3) ‘‘Conclusions’’ to 

‘‘Investigation Conclusion.’’ Finally, 

H10 is becoming a field entitled 

‘‘Additional Manufacturer Narrative,’’ 

and we are adding field H11 entitled 

‘‘Corrected Data.’’ 

D. Changes Proposed for Form FDA 

3500B 

On page 1, we are removing the text 

‘‘nutrition products, such as vitamins 

and minerals, herbal remedies, infant 

formulas, and medical foods.’’ We are 

also going to number each of the 

questions included. 

In section A, for the question ‘‘Did 

any of the following happen?’’ we are 

removing ‘‘Devices)’’ from the last 

option. We are also revising the 

question ‘‘List any relevant tests or 

laboratory data if you know them. 

(Include dates)’’ as two separate 

questions: ‘‘List any relevant tests 

(Include dates)’’; and ‘‘List any relevant 

laboratory data (Include dates)’’ with 

corresponding date fields for ‘‘relevant 

tests’’ and ‘‘laboratory data.’’ 

In section B, we are asking whether 

respondents have a picture of the 

product. Also in section B, we are 

adding the questions ‘‘Does this report 

involve cosmetics, dietary supplements, 

or food?’’ and ‘‘Is therapy still ongoing?’’ These questions pertain to 

pharmacovigilance and the current form 

does not allow for such specificity. We 

are also adding the question, ‘‘Was the 

product compounded by a pharmacy or 

an outsourcing facility?’’ Following the 

question, ‘‘Is the Product 

Compounded?’’ we are adding a check 

box for ‘‘Yes’’ and a checkbox for ‘‘No.’’ 

We are also adding checkboxes within 

the field ‘‘Product Type (check all that 

apply)’’ to correspond with selections 

for ‘‘Over-the-Counter, Generic and 

Biosimilar.’’ Finally, we are revising 

‘‘Name of the . . .’’ to ‘‘Name(s) of 

the . . .’’ for clarity. 

In section C, we are separating ‘‘Other 

identifying information’’ into two fields; 

hoping this improves reporting. New 

fields will be entitled (1) ‘‘Model 

number’’ (2) ‘‘Catalog number’’ (3) ‘‘Lot 

number’’ (4) Serial number’’ (5) ‘‘UDI 

Number and (6) ‘‘Expiration Date.’’ 

In section D we are changing the 

terminology from ‘‘Sex’’ to ‘‘Current 

Gender’’ followed by corresponding 

check boxes next to the options 

‘‘Female’’, ‘‘Male’’, ‘‘Intersex’’, 

‘‘Transgender’’, ‘‘Prefer not to disclose’’. 

In section E, we are revising the 

question ‘‘If you do NOT want your 

identity disclosed to the manufacturer, 

place an ‘X’ in this box:’’ to read ‘‘If you 

do NOT want your identity disclosed to 

the manufacturer/compounder, place an 

‘X’ in this box:’’ 

III. Public Comment 

In the Federal Register of March 16, 

2018 (83 FR 11756), we published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. A number of comments 

were received and are discussed in the 

following paragraphs. 

General comments included 

suggestions that the MedWatch program 

be better advertised to physicians and 

other medical healthcare professionals 

as well as patients. Also, that the forms 

use terminology more familiar to 

healthcare providers and consumers. 

For example, using ‘Medication error’ or 

‘Medication error/product use error’ 

instead of ‘Product use error’ to ensure 

respondents are aware that MedWatch 

forms can be used to report medication 

errors. Other comments suggested 

revisions that might improve or 

otherwise clarify instructions. Finally, 

some comments pertained to the 

advantages of electronic reporting. 

More specific comments included a 

suggestion to add a question to section 

A of Form FDA 3500 related to 

pregnancy. While we agree that 

documenting pregnancy status is 

important, we do not plan on adding an 

additional checkbox for pregnancy at 

this time. Previously (in 2005), we 

proposed adding checkboxes for both 

‘‘Product Used During Pregnancy’’ and 

‘‘Product Used During Breast Feeding.’’ 

However we received comments 

expressing concern that these new data 

fields introduced divergence from 

International Council on Harmonisation 

standards and appeared to duplicate 

information usually provided in the 

narrative section and in coded adverse 

event terms. At the same time, we ask 

readers to note that pregnancy status 

can be captured in field B7 under ‘‘other 

relevant history.’’ 

Another comment suggested adding 

‘‘Physician Assistant’’ to the drop down 

‘‘Occupation’’ menu in section G of 

Form FDA 3500. We appreciate this 


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suggestion and will implement the 

revision. 

We also received comment that some 

users have experienced ‘‘timing out’’ 

while completing Form FDA 3500B 

online and requested that any time limit 

for completing online forms be 

extended. We were not aware of this 

issue and will investigate to see whether 

it relates to the online functionality of 

the form. If so, we will make the 

necessary adjustments. 

While we are especially appreciative 

of the comments received in response to 

our notice, we continue to welcome 

feedback at all times regarding ways we 

might improve the MedWatch Program 

and the associated forms. In addition to 

the revisions discussed previously, on 

our own initiative we are now including 

burden associated with written 

submissions under § 329.100(c)(2) (21 

CFR 329.100(c)(2)) that request a 

temporary waiver from the electronic 

reporting requirements associated with 

postmarket adverse drug events under 

section 760 of the FD&C Act. While we 

expect few such waiver requests, we 

retain a placeholder for one respondent 

annually, and we estimate it takes 1 

hour to complete the request. 

We therefore estimate the burden for 

the information collection as follows. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA center or 21 CFR section and/or FDA form Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Center for Biologics Evaluation and Research/Center 

for Drug Evaluation and Research: 

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

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

600.80, and 1271.350).

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

Form 3500A (§ 310.305 outsourcing facilities) ..... 50 2 100 1.21 ........................ 121 

Center for Devices and Radiological Health: 

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

Form 3500A (part 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 (28 minutes) .. 6,325 

Written requests for temporary waiver under 

§ 329.100(c)(2): 

1 1 1 1 ............................. 1 

Total ...................................................................... ........................ ........................ ........................ ................................ 909,396 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

While we retain the currently 

approved estimate for the information 

collection, as noted previously we have 

added burden associated with written 

submissions under § 329.100. 

Dated: September 4, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19742 Filed 9–11–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3010] 

Evidence-Based Treatment Decision in 

Transplantation: Patient Individualized 

Treatment; Choosing the Right 

Regimen for the Right Patient; Public 

Workshop; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following public 

workshop entitled ‘‘Evidence-Based 

Treatment Decision in Transplantation: 

Patient Individualized Treatment; 

Choosing the Right Regimen for the 

Right Patient.’’ This public workshop is 

intended to discuss potential candidate 

biomarkers to determine organ 

transplant patients’ immunologic risk 

for organ rejection or tolerance. The 

public workshop will include 

discussion of the biomarker 

qualification process and how it could 

be used to develop biomarkers for use 

in clinical trials in transplantation, to 

develop new drugs to address unmet 

needs, and in clinical practice to guide 

patient treatment selection. Speakers 

will be patients who will provide 

perspective on the challenges of living 

with a transplant, managing 

immunosuppression and perspectives 

on tolerability, adherence, and risk that 

may inform patient-reported outcome 

(PRO) and patient-focused drug 

development. 

DATES: The public workshop will be 

held on September 27, 2018, from 8:30 

a.m. to 6 p.m. and September 28, 2018, 

from 8 a.m. to 12:30 p.m. Submit either 

electronic or written comments on this 

public workshop by November 19, 2018. 

See the SUPPLEMENTARY INFORMATION

section for registration date and 

information. 

ADDRESSES: The public workshop will 

be held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503, sections B and C), Silver Spring, 

MD 20993. Entrance for the public 

workshop participants (non-FDA 

employees) is through Building 1 where 

routine security check procedures will 

be performed. For parking and security 

information, please refer to https://

www.fda.gov/AboutFDA/ 

WorkingatFDA/BuildingsandFacilities/ 

WhiteOakCampusInformation/ 

ucm241740.htm. 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

Electronic comments must be submitted 

on or before November 19, 2018. The 


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