Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices 106493 

(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 OMISIRGE 

(omidubicel-onlv). OMISIRGE is 

indicated for use in adults and pediatric 

patients 12 years and older with 

hematologic malignancies who are 

planned for umbilical cord blood 

transplantation following myeloablative 

conditioning to reduce the time to 

neutrophil recovery and the incidence 

of infection. Subsequent to this 

approval, the USPTO received a patent 

term restoration application for 

OMISIRGE (U.S. Patent No. 7,955,852) 

from Gamida Cell Ltd., and the USPTO 

requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

April 3, 2024, FDA advised the USPTO 

that this human biological product had 

undergone a regulatory review period 

and that the approval of OMISIRGE 

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 

OMISIRGE is 4,563 days. Of this time, 

4,242 days occurred during the testing 

phase of the regulatory review period, 

while 321 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: October 21, 2010. FDA 

has verified the applicant’s claim that 

the date the investigational new drug 

application became effective was on 

October 21, 2010. 

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): June 1, 2022. FDA has 

verified the applicant’s claim that the 

biologics license application (BLA) for 

OMISIRGE (BLA B125738) was initially 

submitted on June 1, 2022. 

3. The date the application was 

approved: April 17, 2023. FDA has 

verified the applicant’s claim that BLA 

B125738 was approved on April 17, 

2023. 

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 1,826 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: December 19, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31262 Filed 12–27–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5603] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; New Animal Drug 

and Veterinary Master Files 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the collection of 

information associated with new animal 

drug applications and veterinary master 

files. 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

February 28, 2025. 

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 

February 28, 2025. 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 


ddrumheller on DSK120RN23PROD with NOTICES1
106494 Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices 

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– 

2024–N–5603 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Reporting 

Associated with New Animal Drug and 

Veterinary Master Files.’’ 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 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: 

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: Under the 

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, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

New Animal Drug Applications and 

Veterinary Master Files—21 CFR 514 

and 558, and Section 571 of the Federal 

Food, Drug, and Cosmetic Act (21 

U.S.C. 360ccc) 

OMB Control Number 0910–0032— 

Extension 

This information collection supports 

implementation of section 512 of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 360b), which 

governs new animal drugs. Agency 

regulations in 21 CFR part 514 (part 

514) and associated regulations 21 CFR 

part 558, establish format and content 

requirements regarding new animal 

drug application (NADA) submissions, 

as well as provide for pre-application 

submissions, amended applications, and 

application supplements. This 

information collection also supports 

implementation of section 571 of the 

FD&C Act (21 U.S.C. 360ccc) regarding 

application for conditional approval of 

new animal drug (CNADA) submissions. 

As set forth in the FD&C Act and 

regulations, requisite elements include 

safety and effectiveness data, proposed 

labeling, product manufacturing 

information, and where necessary, 

complete information on food safety 

(including microbial food safety) and 

any methods used to determine residues 

of drug chemicals in edible tissue from 

food producing animals. Applications 

must be prepared as appropriate to 

support the submission. Respondents to 

the information collection are persons 

developing, manufacturing, and/or 

researching new animal drugs. 

We developed Form FDA 356v 

(Application for Approval of a New 

Animal Drug (or Submission to Support 

New Animal Drug Approval)) to provide 

a uniform format for submitting 

requisite information and to ensure 

efficient processing by the Agency. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices 106495 

1Animal drugs intended for use in minor species, 

minor use in major species, or for serious or lifethreatening conditions or unmet animal or human health needs where a demonstration of effectiveness 

would require a complex or particularly difficult 

study or studies. 

Form FDA 356v is available for 

download at https://www.fda.gov/aboutfda/reports-manuals-forms/forms. We 

also develop Agency guidance 

documents that may assist respondents 

with understanding NADA/CNADA 

requirements and related information 

collection activity. This includes FDA 

Guidance #152 (https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/cvm-gfi-152- 

evaluating-safety-antimicrobial-newanimal-drugs-regard-theirmicrobiological-effects), which outlines 

a risk assessment approach for 

evaluating the microbial food safety of 

antimicrobial new animal drugs and 

includes Agency recommendations in 

this regard. 

Under section 512(b)(3) of the FD&C 

Act, any person intending to file an 

NADA or supplemental NADA or a 

request for an investigational exemption 

under section 512(j) of the FD&C Act 

may request a conference prior to 

making a submission. Section 514.5 of 

our regulations (21 CFR 514.5) sets forth 

procedures for pre-submission 

conferences and describes 

documentation associated with making 

requests, and preparing for and 

conducting meetings. We encourage 

sponsors to submit data for review at the 

most appropriate and productive times 

in the drug development process. Rather 

than submitting all data for review as 

part of a complete application, we have 

found that the submission of data 

supporting discrete technical sections 

during the investigational phase is most 

appropriate and productive. This 

‘‘phased review’’ of data submissions 

has created efficiencies for both us and 

the animal pharmaceutical industry. 

We also encourage, as appropriate, the 

submission of a Veterinary Master File 

(VMF). For more information on VMFs 

we invite you to visit https://

www.fda.gov/animal-veterinary/ 

development-approval-process/ 

veterinary-master-files. A VMF provides 

detailed information used in support of 

application submissions. Questions 

regarding VMF submissions may be 

directed to the Center for Veterinary 

Medicine at cvmesubmitter@

fda.hhs.gov. We have found that 

utilizing VMFs has increased the 

efficiency of the animal drug 

development and animal drug review 

processes for both FDA and the animal 

pharmaceutical industry, providing for 

the confidential exchange of 

information with FDA, and a process for 

reporting information outside of an 

NADA/CNADA or an Investigational 

New Animal Drug file, as well as an 

opportunity for increased 

communication with FDA during early 

stages of product development. A holder 

of a VMF may also authorize other 

parties to reference information 

included in the VMF without disclosing 

information in the file to those parties. 

Veterinary master files can be used as 

repositories for information that can be 

referenced in multiple submissions to 

the Agency. 

Section 558.5(i) of our regulations (21 

CFR 558.5(i)) describes the procedure 

for requesting a waiver of the labeling 

requirements in § 558.5(h) if there is 

evidence to indicate that it is unlikely 

a new animal drug would be used in the 

manufacture of a liquid medicated feed. 

Finally, section 571 of the FD&C Act 

established requirements for the 

conditional approval of certain drugs 1

and the procedures for submitting 

CNADAs. Although FDA receives fewer 

than one application submission 

annually under section 571 of the FD&C 

Act when averaged over a 3-year period, 

we use a place holder of one response 

and 1 hour annually to account for 

burden associated with these 

submissions. 

The reporting associated with 

NADAs/CNADAs and related 

submissions is necessary to ensure that 

new animal drugs are in compliance 

with sections 512(b)(1) and 571 of the 

FD&C Act. We use the information 

collected to review the data, labeling, 

and manufacturing controls and 

procedures to evaluate the safety and 

effectiveness of the proposed new 

animal drug. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2

21 CFR part, activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

§ 514; applications and amendments, pre-submission conference requests, evidence to establish safety and effectiveness, manufacturing, labeling, and other changes, 

submission of data studies and other changes.

254 2.8 711 42.25 ............. 30,040 

§ 558.5(i); requirements for liquid medicated feed .............. 254 .01 2.5 5 .................... 13 

Applications for conditional approval submitted under section 571 of the FD&C Act.3 1 3 1 .................... 3 

Form FDA 356V ................................................................... 254 30.8 7,823 0.75 (45 minutes).5,867 

VMF submissions ................................................................. 16 1 16 20 .................. 320 

Total .............................................................................. ........................ ........................ 8,556 ........................ 36,243 

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

2Totals may not sum due to rounding. 

Although we have characterized the 

information collection activity as a 

reporting burden, we include in our 

estimate time required for searching 

data sources and preparing and 

maintaining necessary and applicable 

records. Based on the number of 

sponsors subject to animal drug user 

fees, we estimate that there are 254 

respondents. We use this estimate to 

calculate the ‘‘number of responses per 

respondent’’ by dividing the total 

annual responses by the number of 

respondents except for CNADA 

submission and VMFs. For CNADAs we 

calculate an average of three responses 

and for VMF submissions we calculate 

and average of 16 VMFs. 

Our estimated burden for the 

information collection reflects an 

overall decrease of 2,606 hours and an 

increase of 928 responses. We attribute 


ddrumheller on DSK120RN23PROD with NOTICES1
106496 Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices 

this adjustment to an increase in the 

number of submissions which generate 

a Form FDA 0356v; however, there is 

also a decrease to the submissions we 

received reported under part 514. 

Dated: December 16, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31308 Filed 12–27–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2024–E–0299, FDA– 

2024–E–0301, and FDA–2024–E–0302] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; VEOZAH 

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 VEOZAH and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of applications 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 drug 

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 February 28, 2025. 

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 

June 30, 2025. 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 

February 28, 2025. 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, 

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 Nos. FDA– 

2024–E–0299, FDA–2024–E–0301, and 

FDA–2024–E–0302 for ‘‘Determination 

of Regulatory Review Period for 

Purposes of Patent Extension; 

VEOZAH.’’ 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. 6200, 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 biological 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. 


ddrumheller on DSK120RN23PROD with NOTICES1