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Withdrawn From Sale for Reasons of 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mL, was not withdrawn from sale for 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 


jspears on DSK121TN23PROD with NOTICES1
41730 Federal Register / Vol. 87, No. 133 / Wednesday, July 13, 2022 / Notices 

found no information that would 

indicate that this drug product was 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list REGLAN Injection 

(metoclopramide injection, USP), EQ 5 

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

the ‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. FDA will not 

begin procedures to withdraw approval 

of approved ANDAs that refer to this 

drug product. Additional ANDAs for 

this drug product may also be approved 

by the Agency as long as they meet all 

other legal and regulatory requirements 

for the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: July 7, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14929 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–2012–D–0049] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Reporting Harmful 

and Potentially Harmful Constituents 

in Tobacco Products and Tobacco 

Smoke Under the Federal Food, Drug, 

and Cosmetic Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) 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: Submit written comments 

(including recommendations) on the 

collection of information by August 12, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0732. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St. North Bethesda, MD 

20852, 301–796–8867, 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. 

Reporting Harmful and Potentially 

Harmful Constituents in Tobacco 

Products and Tobacco Smoke Under 

the Federal Food, Drug, and Cosmetic 

Act 

OMB Control Number 0910–0732— 

Extension 

The Family Smoking Prevention and 

Tobacco Control Act (Pub. L. 111–31) 

(Tobacco Control Act), enacted on June 

22, 2009, amended the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) and 

provided FDA with the authority to 

regulate the manufacture, marketing, 

and distribution of cigarettes, cigarette 

tobacco, roll-your-own (RYO) tobacco, 

and smokeless tobacco products to 

protect the public health and to reduce 

tobacco use by minors. The Tobacco 

Control Act also gave FDA the authority 

to issue regulations deeming other 

products that meet the statutory 

definition of a tobacco product to be 

subject to chapter IX of the FD&C Act 

(section 901(b) of the FD&C Act (21 

U.S.C. 387a(b))). 

In accordance with that authority, on 

May 10, 2016, FDA issued a final rule 

deeming all products that meet the 

statutory definition of tobacco product, 

except accessories of newly deemed 

tobacco products, to be subject to FDA’s 

tobacco product authority (final 

deeming rule) (81 FR 28974). 

Chapter IX of the FD&C Act now 

applies to newly regulated products, 

including sections 904(a)(3) and (c)(1) 

(21 U.S.C. 387d(a)(3) and (c)(1)). Section 

904(a)(3) of the FD&C Act requires the 

submission of an initial report from 

each tobacco product manufacturer or 

importer, or agents thereof, listing all 

constituents, including smoke 

constituents as applicable, identified as 

a harmful and potentially harmful 

constituent (HPHC) to health by FDA. 

Reports must be by brand and by 

quantity in each brand and subbrand. 

We note that for cigarettes, smokeless 

tobacco, cigarette filler, and RYO 

tobacco products, this initial reporting 

was completed in 2012. 

Section 904(c)(1) of the FD&C Act 

provides that manufacturers of tobacco 

products not on the market as of June 

22, 2009, must also provide the 

information reportable under section 

904(a)(3) of the FD&C Act at least 90 

days prior to introducing the product 

into interstate commerce. 

FDA has taken several steps to 

identify HPHCs to be reported under 

section 904 of the FD&C Act, including 

issuing a guidance discussing FDA’s 

current thinking on the meaning of the 

term ‘‘harmful and potentially harmful 

constituent’’ in the context of 

implementing the HPHC list 

requirement under section 904(e) of the 

FD&C Act (76 FR 5387, January 31, 

2011, revised guidance issued August 

2016). The guidance is available on the 

internet at https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/harmful-andpotentially-harmful-constituentstobacco-products-used-section-904efederal-food-drug. The current 

established list of HPHCs also is 

available on the internet at https://

www.fda.gov/tobacco-products/rulesregulations-and-guidance/harmful-andpotentially-harmful-constituentstobacco-products-and-tobacco-smokeestablished-list (77 FR 20034, April 3, 

2012). 

The purpose of the information 

collection is to collect statutorily 

mandated information regarding HPHCs 

in certain tobacco products and tobacco 

smoke, by brand and by quantity in each 

brand and subbrand. 

To facilitate the submission of HPHC 

information, Forms FDA 3787a-j, for 

cigarettes, smokeless tobacco products, 

and RYO tobacco products, respectively, 

in both paper and electronic formats, are 

available. Additionally, FDA is 

developing forms to facilitate the 

submission of HPHC information for the 

deemed tobacco products. We intend to 

model these forms on the current HPHC 

reporting forms (i.e., Forms FDA 3787a– 

j). A proposed information collection for 

deemed products will be published in a 

separate Federal Register notice, and we 

will solicit comments on that collection 

at that time. 

Manufacturers or importers, or their 

agents, may submit HPHC information 

either electronically or in paper format. 

The FDA eSubmitter tool, available at 

https://www.fda.gov/industry/fdaVerDate Sep<11>2014 18:49 Jul 12, 2022 Jkt 256001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 E:\FR\FM\13JYN1.SGM 13JYN1

jspears on DSK121TN23PROD with NOTICES1