Federal Register / Vol. 87, No. 75 / Tuesday, April 19, 2022 / Notices 23181 

44This figure is derived from the mean hourly 

wage shown for Telemarketers. See supra note 42. 

It is applied additionally to the ensuing calculation 

of reporting labor cost regarding the Registry 

operator. 

45Staff believes that other non-labor costs would 

be incurred largely by affected entities in the 

ordinary course of business and, beyond that, 

would not materially exceed those ordinary costs. 

(b) Disclosure Labor Cost 

The estimated annual labor cost for 

disclosures for all telemarketing entities 

is $17,923,044. This total is the product 

of applying an assumed hourly wage 

rate of $14.74 44 to the earlier stated 

estimate of 1,215,946 hours pertaining 

to the pre-sale, general and specific 

disclosures. 

(c) Reporting Labor Cost 

Estimated labor cost supplying basic 

identifying information to the Registry 

operator is $3,228 (219 hours × $14.74 

per hour). 

Thus, cumulatively for both new and 

existing telemarketing entities total 

labor costs are $18,367,441 [($441,169 

recordkeeping) + ($17,923,044 

disclosure) + ($3,228 reporting)]. 

Estimated Annual Non-Labor Cost: 

$4,642,347 

(a) Recordkeeping 

Staff believes that the capital and 

start-up costs associated with the TSR’s 

recordkeeping provisions are de 

minimis. Although staff believes that 

most affected entities would maintain 

the required records in the ordinary 

course of business, consistent with its 

prior analyses, staff estimates that the 

estimated 4,835 telemarketing entities 

subject to the Rule continue to spend an 

annual amount of $50 each on office 

supplies as a result of the Rule’s 

recordkeeping requirements, for a total 

recordkeeping cost burden of $241,750. 

(b) Disclosure 

Applying the disclosure estimates of 

1,215,946 hours to an estimated 

commercial calling rate of 6 cents per 

minute ($3.60 per hour), staff estimates 

a total of $4,377,406 in telephone 

charges.45 Thus, total capital and/or 

other non-labor costs are $4,619,156 

($241,750 (office supplies)) + $4,377,406 

(telephone charges)). 

Request for Comments 

Pursuant to Section 3506(c)(2)(A) of 

the PRA, the FTC invites comments on: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information will have practical utility; 

(2) the accuracy of the agency’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 maintaining records and 

providing disclosures to consumers. All 

comments must be received on or before 

June 21, 2022. 

You can file a comment online or on 

paper. For the FTC to consider your 

comment, we must receive it on or 

before June 21, 2022. Write 

‘‘Telemarketing Sales Rule; PRA 

Comment: FTC File No. P072108’’ on 

your comment. Your comment— 

including your name and your state— 

will be placed on the public record of 

this proceeding, including the https://

www.regulations.gov website. 

Due to the public health emergency in 

response to the COVID–19 outbreak and 

the agency’s heightened security 

screening, postal mail addressed to the 

Commission will be subject to delay. We 

encourage you to submit your comments 

online through the https://

www.regulations.gov website. 

If you prefer to file your comment on 

paper, write ‘‘Telemarketing Sales Rule; 

PRA Comment: FTC File No. P072108’’ 

on your comment and on the envelope, 

and mail your comment to the following 

address: Federal Trade Commission, 

Office of the Secretary, 600 

Pennsylvania Avenue NW, Suite CC– 

5610 (Annex J), Washington, DC 20580; 

or deliver your comment to the 

following address: Federal Trade 

Commission, Office of the Secretary, 

Constitution Center, 400 7th Street SW, 

5th Floor, Suite 5610 (Annex J), 

Washington, DC 20024. If possible, 

submit your paper comment to the 

Commission by courier or overnight 

service. 

Because your comment will become 

publicly available at https://

www.regulations.gov, you are solely 

responsible for making sure that your 

comment does not include any sensitive 

or confidential information. In 

particular, your comment should not 

include any sensitive personal 

information, such as your or anyone 

else’s Social Security number; date of 

birth; driver’s license number or other 

state identification number, or foreign 

country equivalent; passport number; 

financial account number; or credit or 

debit card number. You are also solely 

responsible for making sure that your 

comment does not include any sensitive 

health information, such as medical 

records or other individually 

identifiable health information. In 

addition, your comment should not 

include any ‘‘trade secret or any 

commercial or financial information 

which . . . . is privileged or 

confidential’’ —as provided by Section 

6(f) of the FTC Act, 15 U.S.C. 46(f), and 

FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)— 

including in particular competitively 

sensitive information such as costs, 

sales statistics, inventories, formulas, 

patterns, devices, manufacturing 

processes, or customer names. 

Comments containing material for 

which confidential treatment is 

requested must be filed in paper form, 

must be clearly labeled ‘‘Confidential,’’ 

and must comply with FTC Rule 4.9(c). 

In particular, the written request for 

confidential treatment that accompanies 

the comment must include the factual 

and legal basis for the request, and must 

identify the specific portions of the 

comment to be withheld from the public 

record. See FTC Rule 4.9(c). Your 

comment will be kept confidential only 

if the General Counsel grants your 

request in accordance with the law and 

the public interest. Once your comment 

has been posted publicly at 

www.regulations.gov, we cannot redact 

or remove your comment unless you 

submit a confidentiality request that 

meets the requirements for such 

treatment under FTC Rule 4.9(c), and 

the General Counsel grants that request. 

The FTC Act and other laws that the 

Commission administers permit the 

collection of public comments to 

consider and use in this proceeding, as 

appropriate. The Commission will 

consider all timely and responsive 

public comments that it receives on or 

before June 21, 2022. For information on 

the Commission’s privacy policy, 

including routine uses permitted by the 

Privacy Act, see https://www.ftc.gov/ 

site-information/privacy-policy. 

Josephine Liu, 

Assistant General Counsel for Legal Counsel. 

[FR Doc. 2022–08330 Filed 4–18–22; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0553] 

Evaluating the Public Health 

Importance of Food Allergens Other 

Than the Major Food Allergens Listed 

in the Federal Food, Drug, and 

Cosmetic Act; Draft Guidance for FDA 

Staff and Stakeholders; Availability; 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request 

AGENCY: Food and Drug Administration, 

HHS. 


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23182 Federal Register / Vol. 87, No. 75 / Tuesday, April 19, 2022 / Notices 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the availability of a draft 

guidance for FDA staff and stakeholders 

entitled ‘‘Evaluating the Public Health 

Importance of Food Allergens Other 

Than the Major Food Allergens Listed in 

the Federal Food, Drug, and Cosmetic 

Act.’’ This draft guidance, when 

finalized, will explain our current 

thinking on the approach we generally 

intend to take when we evaluate the 

public health importance of a food 

allergen other than milk, eggs, fish, 

Crustacean shellfish, tree nuts, wheat, 

peanuts, soybean, and sesame (nonlisted food allergen). (In April 2021, the 

Food Allergy Safety, Treatment, 

Education, and Research Act of 2021 

amended the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) to add sesame 

to the definition of ‘‘major food 

allergen.’’ This statutory requirement 

goes into effect on January 1, 2023). We 

are also announcing an opportunity for 

public comment on our proposed 

collection of information. This draft 

guidance is not final nor is it in effect 

at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by August 17, 2022 to ensure that we 

consider your comment on this draft 

guidance before we begin work on the 

final version of the guidance. Submit 

electronic or written comments on the 

proposed collection of information in 

the draft guidance by August 17, 2022. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2021–N–0553 for ‘‘Evaluating the Public 

Health Importance of Food Allergens 

Other Than the Major Food Allergens 

Listed in the Federal Food, Drug, and 

Cosmetic Act.’’ Received comments will 

be placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ We 

will review this copy, including the 

claimed confidential information, in our 

consideration of comments. The second 

copy, which will have the claimed 

confidential information redacted/ 

blacked out, will be available for public 

viewing and posted on https://

www.regulations.gov. Submit both 

copies to the Dockets Management Staff. 

If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Compliance Policy Staff, Office of 

Compliance (HFS–605), Center for Food 

Safety and Applied Nutrition, Food and 

Drug Administration, 5001 Campus Dr., 

College Park, MD 20740. Send two selfaddressed adhesive labels to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

With regard to the draft guidance: 

Stefano Luccioli, Office of Compliance 

(HFS–605), Center for Food Safety and 

Applied Nutrition, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–1283, 

CFSANCompliancepolicy@fda.hhs.gov; 

or Alexandra Jurewitz, Office of 

Regulations and Policy (HFS–024), 

Center for Food Safety and Applied 

Nutrition, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2378. 

With regard to the proposed collection 

of information: 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: 

I. Background 

Food allergy can be broadly defined 

as an adverse health effect arising from 

a specific immune response that occurs 

reproducibly on exposure to a given 

food. A food allergen is the food or 

component(s) (often a protein) of a food 

that elicits specific immunologic 

reactions. While many different types of 

food allergies have been identified, food 

allergies that are most studied and 

understood clinically are those due to 

immunoglobulin E antibodies (IgE) that 

cause the body to release inflammatory 

chemicals. The most severe and 

immediately life-threatening food 

allergies are those that are mediated by 


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Federal Register / Vol. 87, No. 75 / Tuesday, April 19, 2022 / Notices 23183 

IgE and are capable of triggering 

anaphylaxis, which can be fatal. The 

focus of the draft guidance is IgEmediated food allergy. 

In general, the regulatory framework 

of the FD&C Act and our regulations 

implementing the FD&C Act broadly 

apply to the production of food that is 

or contains a food allergen through 

statutory and regulatory provisions 

regarding: (1) Food labeling; (2) food 

production (e.g., manufacturing, 

processing, packing, and holding food); 

and (3) the safety of substances added 

to food. The Food Allergen Labeling and 

Consumer Protection Act of 2004 

amended the FD&C Act to provide us 

with additional, specific authority 

regarding the labeling of a food (other 

than a raw agricultural commodity) that 

bears or contains a ‘‘major food 

allergen.’’ Under section 403(w) of the 

FD&C Act (21 U.S.C. 343(w)), a food is 

misbranded if it contains a major food 

allergen and fails to declare that major 

food allergen as specified on its label 

using the major food allergen’s common 

or usual name. Section 201(qq)(1) of the 

FD&C Act (21 U.S.C. 321(qq)(1)) defines 

a ‘‘major food allergen,’’ in part, as any 

of the following: Milk, eggs, fish (e.g., 

bass, flounder, or cod), Crustacean 

shellfish, tree nuts (e.g., almonds, 

pecans, or walnuts), wheat, peanuts, 

and soybean. In April 2021, the Food 

Allergy Safety, Treatment, Education, 

and Research Act of 2021 amended 

section 201(qq) of the FD&C Act to add 

sesame to the definition of ‘‘major food 

allergen.’’ This amendment applies to 

‘‘any food that is introduced or 

delivered for introduction into interstate 

commerce on or after January 1, 2023’’ 

(Pub. L. 117–11). 

We are announcing the availability of 

a draft guidance for FDA staff and 

stakeholders entitled ‘‘Evaluating the 

Public Health Importance of Food 

Allergens Other Than the Major Food 

Allergens Listed in the Federal Food, 

Drug, and Cosmetic Act.’’ We are 

issuing the draft guidance consistent 

with our good guidance practices 

regulation (21 CFR 10.115). The draft 

guidance, when finalized, will represent 

the current thinking of FDA on this 

topic. It does not establish any rights for 

any person and is not binding on FDA 

or the public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. 

The draft guidance discusses: (1) The 

scientific factors that we would 

generally intend to consider when 

evaluating the public health importance 

of a non-listed food allergen; (2) other 

information, relevant to the labeling and 

production of food containing the food 

allergen, that we would generally intend 

to consider when evaluating the public 

health importance of a non-listed food 

allergen; and (3) our tentative 

recommendations for how to identify 

and evaluate the body of evidence 

applicable to an evaluation of the public 

health importance of a non-listed food 

allergen. 

II. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

(PRA) (44 U.S.C. 3501–3521), 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 

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. 

Evaluating the Public Health 

Importance of Food Allergens Other 

Than the Major Food Allergens Listed 

in the Federal Food, Drug, and 

Cosmetic Act 

OMB Control Number 0910–0191— 

Revision 

The draft guidance, when finalized, 

will describe our current thinking on 

the approach we generally intend to 

take when we evaluate the public health 

importance of a non-listed food allergen. 

Respondents who are interested in 

asking FDA to evaluate a food or 

component of food as a food allergen of 

public health importance may submit 

information relevant to their request in 

accordance with § 10.30 (21 CFR 10.30). 

We recommend that the submitted 

information include data demonstrating 

that the food allergy is IgE-mediated and 

data for prevalence, severity, and 

potency, as described in the draft 

guidance. 

Description of respondents: The 

respondents to this collection of 

information are any persons who file 

citizen petitions under 21 CFR 10.30, 

which may include manufacturers and 

packers of packaged foods sold in the 

United States that may contain a nonlisted food allergen and individuals and 

organizations interested in evaluating a 

food or component of food as a food 

allergen of public health importance. 

Respondents are from the private sector 

(for-profit businesses and non-profit 

entities). 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity; 21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Avg. burden 

per response Total hours 

Submitting data for evidence of IgE-mediated food allergy, 

prevalence, severity, and potency; 10.30 ........................ 1 1 1 80 80 

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

We base these estimates on our 

experience with reviewing and 

evaluating data for food allergens. We 

estimate that one respondent will spend 

approximately 80 hours developing and 


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23184 Federal Register / Vol. 87, No. 75 / Tuesday, April 19, 2022 / Notices 

submitting the information to FDA each 

year. 

This draft guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

The collections of information in 21 

CFR part 10 have been approved under 

OMB control number 0910–0191. The 

collections of information in 21 CFR 

part 101 have been approved under 

OMB control number 0910–0381. The 

collections of information in section 

403(w) of the FD&C Act have been 

approved under OMB control number 

0910–0792. The collections of 

information in 21 CFR part 117 have 

been approved under OMB control 

number 0910–0751. The collections of 

information for Form FDA 3800 have 

been approved under OMB control 

number 0910–0645. The collections of 

information for Form FDA 3500 have 

been approved under OMB control 

number 0910–0291. The collections of 

information in 21 CFR 70.25, 71.1, 

170.36, 171.1, 172, 173, 179, and 180 

have been approved under OMB control 

number 0910–0016. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/FoodGuidances, 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https://

www.regulations.gov. Use the FDA 

website listed in the previous sentence 

to find the most current version of the 

guidance. 

Dated: April 13, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08303 Filed 4–18–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0030] 

Fresenius Kabi USA, LLC, et al.; 

Withdrawal of Approval of Five 

Abbreviated New Drug Applications; 

Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register on February 28, 2022. The 

document announced the withdrawal of 

approval of five abbreviated new drug 

applications (ANDAs) from multiple 

applicants as of March 30, 2022. The 

document indicated that FDA was 

withdrawing approval of the following 

ANDA after receiving a withdrawal 

request from Jiangsu Hengrui 

Pharmaceuticals Co., Ltd., U.S. Agent, 

Venus Pharmaceutical Laboratories Inc., 

506 Carnegie Center, Suite 100, 

Princeton, NJ 08540: ANDA 091008, 

Gabapentin Capsules, 100 milligrams 

(mg), 300 mg, and 400 mg. Before FDA 

withdrew the approval of this ANDA, 

Jiangsu Hengrui Pharmaceuticals Co., 

Ltd., informed FDA that it did not want 

the approval of the ANDA withdrawn. 

Because Jiangsu Hengrui 

Pharmaceuticals Co., Ltd., timely 

requested that approval of this ANDA 

not be withdrawn, the approval of 

ANDA 091008 is still in effect. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1676, 

Silver Spring, MD 20993–0002, 240– 

402–6980, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of February 28, 2022 

(87 FR 11079), appearing on page 11079 

in FR Doc. 2022–04153, the following 

correction is made: 

On page 11079, in the table, the entry 

for ANDA 091008 is removed. 

Dated: April 13, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08299 Filed 4–18–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0317] 

Yvelice Villaman-Bencosme: Final 

Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

issuing an order under the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) permanently debarring Yvelice 

Villaman-Bencosme from providing 

services in any capacity to a person that 

has an approved or pending drug 

product application. FDA bases this 

order on a finding that Yvelice 

Villaman-Bencosme was convicted of a 

felony under Federal law for conduct 

relating to the development or approval, 

including the process of development or 

approval, of a drug product under the 

FD&C Act. Ms. Villaman-Bencosme was 

given notice of the proposed permanent 

debarment and was given an 

opportunity to request a hearing to show 

why she should not be debarred. As of 

December 13, 2021 (30 days after receipt 

of the notice), Ms. Villaman-Bencosme 

had not responded. Ms. VillamanBencosme’s failure to respond and 

request a hearing constitutes a waiver of 

her right to a hearing concerning this 

action. 

DATES: This order is applicable April 19, 

2022. 

ADDRESSES: Submit applications for 

termination of debarment to the Dockets 

Management Staff, Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852, 240–402– 

7500, or at https://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Jaime Espinosa, Division of Enforcement 

(ELEM–4029), Office of Strategic 

Planning and Operational Policy, Office 

of Regulatory Affairs, Food and Drug 

Administration, 12420 Parklawn Dr., 

Rockville, MD 20857, 240–402–8743, 

debarments@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(a)(2)(A) of the FD&C Act 

(21 U.S.C. 335a(a)(2)(A)) requires 

debarment of an individual from 

providing services in any capacity to a 

person that has an approved or pending 

drug product application if FDA finds 

that the individual has been convicted 

of a felony under Federal law for 

conduct relating to the development or 

approval, including the process of 

development or approval, of any drug 

product under the FD&C Act. On March 

19, 2021, Ms. Villaman-Bencosme was 

convicted as defined in section 306(l)(1) 

of the FD&C Act when judgment was 

entered against her in the U.S. District 

Court for the Southern District of 

Florida-Miami Division, after her plea of 

guilty, to one count of Conspiracy to 

Commit Wire Fraud in violation of 18 

U.S.C. 1349. 

The factual basis for this conviction is 

as follows: Ms. Villaman-Bencosme was 

a licensed medical doctor who served as 

a clinical investigator at Unlimited 

Medical Research, LLC from about 

September 2013 through June 2016. Ms. 

Villaman-Bencosme conspired with 

others to unlawfully enrich herself by 

making materially false representations 

about clinical trials; fabricating data and 

the participation of subjects in those 

clinical trials; concealing from FDA, 

sponsors, and contract research 

organizations the fact that the data and 

participation of subjects had been 


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