Federal Register / Vol. 87, No. 133 / Wednesday, July 13, 2022 / Notices 41727 

product was refused entry on April 5, 

2021. 

On or about March 17, 2021, Mr. 

Hampton-Bey II offered for import a 

parcel intercepted and processed by 

FDA at the Newark IMF and which was 

addressed to him. FDA determined that 

the product contained in this parcel was 

364 tablets of BEGMA–100 Sildenafil 

Citrate Tablets 100 MG and was a 

misbranded drug because the article was 

determined to be a prescription drug but 

did not include the symbol ‘‘Rx only’’ 

on its label. The product was refused 

entry on April 23, 2021. 

On or about March 24, 2021, Mr. 

Hampton-Bey II offered for import a 

parcel intercepted and processed by 

FDA at the Chicago IMF and which was 

addressed to him. FDA determined that 

the product contained in this parcel was 

870 tablets of sildenafil citrate and was 

a misbranded drug because the article 

was determined to be a prescription 

drug but did not include the symbol ‘‘Rx 

only’’ on its label. The product was 

refused entry on April 19, 2021. 

On or about April 20, 2021, Mr. 

Hampton-Bey II offered for import a 

parcel intercepted and processed by 

FDA at the Chicago IMF and which was 

addressed to him. FDA determined that 

the product contained in this parcel was 

800 tablets of Sildenafil 100 MG Tablets 

and was a misbranded drug because the 

article was determined to be a drug that 

was not included in a list required by 

section 510(j) of the FD&C Act. The 

product was refused entry on May 11, 

2021. 

As a result of this pattern of importing 

or offering for import misbranded drugs 

(i.e. in an amount, frequency, or dosage 

that is inconsistent with his personal or 

household use) that are not designated 

in an authorized electronic data 

interchange system as products 

regulated by FDA, in accordance with 

section 306(b)(3)(D) of the FD&C Act, 

FDA sent Mr. Hampton-Bey II, by 

certified mail on April 4, 2022, a notice 

proposing to debar him for a 5-year 

period from importing or offering for 

import any drug into the United States. 

In proposing a debarment period, 

FDA weighed the considerations set 

forth in section 306(c)(3) of the FD&C 

Act that it considered applicable to Mr. 

Hampton-Bey II’s pattern of conduct 

and concluded that his conduct 

warranted the imposition of a 5-year 

period of debarment. 

The proposal informed Mr. HamptonBey II of the proposed debarment and 

offered him an opportunity to request a 

hearing, providing 30 days from the date 

of receipt of the letter in which to file 

the request, and advised him that failure 

to request a hearing constituted a waiver 

of the opportunity for a hearing and of 

any contentions concerning this action. 

Mr. Hampton-Bey II received the 

proposal and notice of opportunity for 

a hearing on April 8, 2022. Mr. 

Hampton-Bey II failed to request a 

hearing within the timeframe prescribed 

by regulation and has, therefore, waived 

his opportunity for a hearing and 

waived any contentions concerning his 

debarment (21 CFR part 12). 

II. Findings and Order 

Therefore, the Assistant 

Commissioner, Office of Human and 

Animal Food Operations, under section 

306(b)(3)(D) of the FD&C Act, under 

authority delegated to the Assistant 

Commissioner, finds that Mr. Kris A. 

Hampton-Bey II has engaged in a pattern 

of importing or offering for import 

misbranded drugs (i.e. in an amount, 

frequency, or dosage that is inconsistent 

with his personal or household use) that 

are not designated in an authorized 

electronic data interchange system as 

products regulated by FDA. FDA finds 

that this pattern of conduct should be 

accorded a debarment period of 5 years 

as provided by section 306(c)(2)(A)(iii) 

of the FD&C Act. 

As a result of the foregoing finding, 

Mr. Hampton-Bey II is debarred for a 

period of 5 years from importing or 

offering for import any drug into the 

United States, applicable (see DATES). 

Pursuant to section 301(cc) of the FD&C 

Act (21 U.S.C. 331(cc)), the importing or 

offering for import into the United 

States of any drug by, with the 

assistance of, or at the direction of Mr. 

Hampton-Bey II is a prohibited act. 

Any application by Mr. Hampton-Bey 

II for termination of debarment under 

section 306(d)(1) of the FD&C Act 

should be identified with Docket No. 

FDA–2021–N–1322 and sent to the 

Dockets Management Staff (see 

ADDRESSES). The public availability of 

information in these submissions is 

governed by 21 CFR 10.20(j). 

Publicly available submissions will be 

placed in the docket and will be 

viewable at http://www.regulations.gov 

or at the Dockets Management Staff (see 

ADDRESSES) between 9 a.m. and 4 p.m., 

Monday through Friday, 240–402–7500. 

Dated: July 5, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14899 Filed 7–12–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–E–2275] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; BLENREP 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for BLENREP and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human 

biological product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by September 12, 2022. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

January 9, 2023. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

September 12, 2022. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

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, 


jspears on DSK121TN23PROD with NOTICES1
41728 Federal Register / Vol. 87, No. 133 / Wednesday, July 13, 2022 / Notices 

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– 

2020–E–2275 for ‘‘Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; BLENREP.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), 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.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its 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 § 10.20 (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. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6250, Silver Spring, MD 20993, 

301–796–3600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Drug Price Competition and 

Patent Term Restoration Act of 1984 

(Pub. L. 98–417) and the Generic 

Animal Drug and Patent Term 

Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug or biologic product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: a testing phase and 

an approval phase. For human 

biological products, the testing phase 

begins when the exemption to permit 

the clinical investigations of the 

biological product becomes effective 

and runs until the approval phase 

begins. The approval phase starts with 

the initial submission of an application 

to market the human biological product 

and continues until FDA grants 

permission to market the biological 

product. Although only a portion of a 

regulatory review period may count 

toward the actual amount of extension 

that the Director of USPTO may award 

(for example, half the testing phase must 

be subtracted as well as any time that 

may have occurred before the patent 

was issued), FDA’s determination of the 

length of a regulatory review period for 

a human biological product will include 

all of the testing phase and approval 

phase as specified in 35 U.S.C. 

156(g)(1)(B). 

FDA has approved for marketing the 

human biologic product BLENREP 

(belantamab mafodotin-blmf). BLENREP 

is indicated for the treatment of adult 

patients with relapsed or refractory 

multiple myeloma who have received at 

least four prior therapies including an 

anti-CD38 monoclonal antibody, a 

proteasome inhibitor, and an 

immunomodulatory agent. Subsequent 

to this approval, the USPTO received a 

patent term restoration application for 

BLENREP (U.S. Patent No. 9,273,141) 

from Glaxo Group Ltd, and the USPTO 

requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

March 1, 2021, FDA advised the USPTO 

that this human biological product had 

undergone a regulatory review period 

and that the approval of BLENREP 

represented the first permitted 

commercial marketing or use of the 

product. Thereafter, the USPTO 

requested that FDA determine the 

product’s regulatory review period. 

II. Determination of Regulatory Review 

Period 

FDA has determined that the 

applicable regulatory review period for 

BLENREP is 2,352 days. Of this time, 

2,107 days occurred during the testing 

phase of the regulatory review period, 

while 245 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 355(i)) 

became effective: February 28, 2014. 

FDA has verified the applicant’s claim 

that the date the investigational new 

drug application became effective was 

on February 28, 2014. 

2. The date the application was 

initially submitted with respect to the 

human biological product under section 

351 of the Public Health Service Act (42 

U.S.C. 262): December 5, 2019. FDA has 

verified the applicant’s claim that the 

biologics license application (BLA) for 

BLENREP (BLA 761158) was initially 

submitted on December 5, 2019. 

3. The date the application was 

approved: August 5, 2020. FDA has 

verified the applicant’s claim that BLA 

761158 was approved on August 5, 

2020. 


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Federal Register / Vol. 87, No. 133 / Wednesday, July 13, 2022 / Notices 41729 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 803 days of patent 

term extension. 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: July 7, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14916 Filed 7–12–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–P–0115] 

Determination That REGLAN Injection 

(Metoclopramide Injection, USP), 

Equivalent to 5 Milligrams Base/ 

Milliliter and Equivalent to 10 

Milligrams Base/Milliliter, Was Not 

Withdrawn From Sale for Reasons of 

Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) has 

determined that REGLAN Injection 

(metoclopramide injection, USP), 

equivalent to (EQ) 5 milligrams (mg) 

base/milliliter (mL) and EQ 10 mg base/ 

mL, was not withdrawn from sale for 

reasons of safety or effectiveness. This 

determination means that FDA will not 

begin procedures to withdraw approval 

of abbreviated new drug applications 

(ANDAs) that refer to this drug product, 

and it will allow FDA to continue to 

approve ANDAs that refer to the 

product as long as they meet relevant 

legal and regulatory requirements. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gottlieb, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6210, 

Silver Spring, MD 20993–0002, 301– 

796–6650, daniel.gottlieb@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Section 

505(j) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

355(j)) allows the submission of an 

ANDA to market a generic version of a 

previously approved drug product. To 

obtain approval, the ANDA applicant 

must show, among other things, that the 

generic drug product: (1) has the same 

active ingredient(s), dosage form, route 

of administration, strength, conditions 

of use, and (with certain exceptions) 

labeling as the listed drug, which is a 

version of the drug that was previously 

approved and (2) is bioequivalent to the 

listed drug. ANDA applicants do not 

have to repeat the extensive clinical 

testing otherwise necessary to gain 

approval of a new drug application 

(NDA). 

Section 505(j)(7) of the FD&C Act 

requires FDA to publish a list of all 

approved drugs. FDA publishes this list 

as part of the ‘‘Approved Drug Products 

With Therapeutic Equivalence 

Evaluations,’’ which is known generally 

as the ‘‘Orange Book.’’ Under FDA 

regulations, drugs are removed from the 

list if the Agency withdraws or 

suspends approval of the drug’s NDA or 

ANDA for reasons of safety or 

effectiveness or if FDA determines that 

the listed drug was withdrawn from sale 

for reasons of safety or effectiveness (21 

CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

FDA’s approval of an ANDA that refers 

to the listed drug (§ 314.161 (21 CFR 

314.161)). FDA may not approve an 

ANDA that does not refer to a listed 

drug. 

REGLAN Injection (metoclopramide 

injection, USP), EQ 5 mg base/mL and 

EQ 10 mg base/mL, is the subject of 

NDA 017862, held by Hikma 

Pharmaceuticals USA Inc., and initially 

approved on February 7, 1979 (EQ 5 mg 

base/mL) and May 28, 1987 (EQ 10 mg 

base/mL). REGLAN is indicated for the 

relief of symptoms associated with acute 

and recurrent diabetic gastric stasis, 

prophylaxis of vomiting associated with 

emetogenic cancer therapy, and 

prophylaxis of postoperative nausea and 

vomiting in those circumstances where 

nasogastric suction is undesirable. 

REGLAN may also be used to facilitate 

small bowel intubation in adults and 

pediatric patients in whom the tube 

does not pass the pylorus with 

conventional maneuvers or to stimulate 

gastric emptying and intestinal transit of 

barium in cases where delayed 

emptying interferes with radiological 

examination of the stomach and/or 

small intestine. 

REGLAN Injection (metoclopramide 

injection, USP), EQ 5 mg base/mL and 

EQ 10 mg base/mL, is currently listed in 

the ‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Baxter Healthcare Corp. submitted a 

citizen petition dated February 1, 2022 

(Docket No. FDA–2022–P–0115), under 

21 CFR 10.30, requesting that the 

Agency determine whether REGLAN 

Injection (metoclopramide injection, 

USP), 5 mg base/mL, was withdrawn 

from sale for reasons of safety or 

effectiveness. Although the citizen 

petition did not address the EQ 10 mg 

base/mL strength, that strength has also 

been discontinued. On our own 

initiative, we have also determined 

whether that strength was withdrawn 

for safety or effectiveness reasons. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that REGLAN Injection 

(metoclopramide injection, USP), EQ 5 

mg base/mL and EQ 10 mg base/mL, 

was not withdrawn for reasons of safety 

or effectiveness. The petitioner has 

identified no data or other information 

suggesting that this drug product was 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of REGLAN 

Injection (metoclopramide injection, 

USP), EQ 5 mg base/mL and EQ 10 mg 

base/mL, from sale. We have also 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events. We have 


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