Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices 80317 

TABLE 1—NEW DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued 

Active ingredient(s) 

Latanoprost 

Omidenepag isopropyl 

Risperidone 

Semaglutide 

Tapinarof 

III. Drug Products for Which Revised 

Draft Product-Specific Guidances Are 

Available 

FDA is announcing the availability of 

revised draft product-specific guidances 

for industry for drug products 

containing the following active 

ingredients: 

TABLE 2—REVISED DRAFT PRODUCTSPECIFIC GUIDANCES FOR DRUG

PRODUCTS

Active ingredient(s) 

Albuterol sulfate 

Betamethasone acetate; Betamethasone sodium phosphate 

Budesonide; Formoterol fumarate dihydrate 

Emtricitabine; Tenofovir alafenamide fumarate 

Ferumoxytol 

Fluticasone propionate 

Fluticasone propionate; Salmeterol xinafoate 

Fulvestrant 

Gabapentin 

Glatiramer acetate 

Levalbuterol tartrate 

Mometasone furoate 

Naltrexone 

Primidone 

Semaglutide 

Sotorasib 

Soybean oil 

Tiotropium bromide 

For a complete history of previously 

published Federal Register notices 

related to product-specific guidances, go 

to https://www.regulations.gov and 

enter Docket No. FDA–2007–D–0369. 

These draft guidances are being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). These draft guidances, when 

finalized, will represent the current 

thinking of FDA on, among other things, 

the product-specific design of BE 

studies to support ANDAs. They do not 

establish any rights for any person and 

are not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

IV. Paperwork Reduction Act of 1995 

FDA tentatively concludes that these 

draft guidances contain no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

V. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: November 14, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–25485 Filed 11–16–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2020–E–2333; FDA– 

2020–E–2334; FDA–2020–E–2336; and FDA– 

2020–E–2337] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ROZLYTREK INJECTION; 

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 of July 8, 2022. The document 

announced the determination of the 

regulatory review period for 

ROZLYTREK INJECTION (entrectinib) 

for purposes of patent extension. The 

document was published with an 

incorrect dosage form. This notice 

corrects the dosage form of the drug 

product. 

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: 

Correction 

In the Federal Register of July 8, 2022 

(87 FR 40849), the dosage form for the 

human drug product ROZLYTREK 

(entrectinib), NDA 212726, is corrected 

from ‘‘INJECTION’’ to ‘‘CAPSULES’’ for 

all instances mentioned in the notice. 

Specifically, the drug product dosage 

form is corrected from ‘‘INJECTION’’ to 

‘‘CAPSULES’’ in the following 

locations: 

1. On page 40849, the following 

corrections are made: 

• In the second column, the title of 

the document is corrected to read: 

‘‘Determination of Regulatory Review 

Period for Purposes of Patent Extension; 

ROZLYTREK CAPSULES.’’ 

• In the second column, the first 

sentence under the SUMMARY section is 

corrected to read: ‘‘The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for ROZLYTREK CAPSULES and is 

publishing this notice of that 

determination as required by law.’’ 

• In the third column, the first 

sentence under the section Instructions 

is corrected to read: ‘‘All submissions 

received must include the Docket Nos. 

FDA–2020–E–2333; FDA–2020–E–2334; 

FDA–2020–E–2336; and FDA–2020–E– 

2337 for ‘Determination of Regulatory 

Review Period for Purposes of Patent 

Extension; ROZLYTREK CAPSULES.’’’ 

2. On page 40850, the following 

corrections are made: 

• In the second column, under 

section I. Background of the 

SUPPLEMENTARY INFORMATION section, the 

third paragraph introduction is 

corrected to read: ‘‘FDA has approved 

for marketing the human drug product, 

ROZLYTREK CAPSULES (entrectinib), 

NDA 212726, indicated for the 

treatment of:’’ 

• In the second and third columns, 

under section I. Background of the 

SUPPLEMENTARY INFORMATION section, the 

last paragraph is corrected to read: 

‘‘Subsequent to this approval, the 

USPTO received patent term restoration 

applications for ROZLYTREK 

CAPSULES (U.S. Patent Nos. 8,299,057; 

8,673,893; 9,029,356; and 9,085,565) 

from Genentech, Inc., and the USPTO 

requested FDA’s assistance in 

determining the patents’ eligibility for 

patent term restoration. In a letter dated 

March 1, 2021, FDA advised the USPTO 

that this human drug product had 

undergone a regulatory review period 

and that the approval of ROZLYTREK 

CAPSULES represented the first 

permitted commercial marketing or use 

of the product. Thereafter, the USPTO 

requested that FDA determine the 

product’s regulatory review period.’’ 

• In the third column, under II. 

Determination of Regulatory Review 

Period, the first sentence of the 

introductory paragraph is corrected to 

read: ‘‘FDA has determined that the 

applicable regulatory review period for 

ROZLYTREK CAPSULES is 1,968 

days.’’ 

• In the third column, under II. 

Determination of Regulatory Review 

Period, the second sentence of the third 

paragraph is corrected to read: ‘‘FDA 


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80318 Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices 

has verified the applicant’s claims that 

the new drug application (NDA) for 

ROZLYTREK CAPSULES (NDA 212726) 

was initially submitted on December 18, 

2018.’’ 

Dated: November 14, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–25489 Filed 11–16–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: Scientific 

Registry of Transplant Recipients 

Information Collection Effort for 

Potential Donors for Living Organ 

Donation, OMB No. 0906–0034— 

Extension 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than January 16, 2024. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N39, 5600 Fishers 

Lane, Rockville, Maryland 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Joella Roland, the HRSA 

Information Collection Clearance 

Officer, at (301) 945–0232. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

Scientific Registry of Transplant 

Recipients Information Collection Effort 

for Potential Donors for Living Organ 

Donation, OMB No. 0906–0034— 

Extension. 

Abstract: The Scientific Registry of 

Transplant Recipients (SRTR) is 

administered under contract with 

HRSA, an agency within HHS. HHS is 

authorized to establish and maintain 

mechanisms to evaluate the long-term 

effects associated with living organ 

donations (42 U.S.C. 273a) and is 

required to submit to Congress an 

annual report on the long-term health 

effects of living donation (42 U.S.C. 

273b). In 2018, the SRTR contractor 

implemented a pilot living donor 

registry in which transplant programs 

registered all potential living organ 

donors who provided informed consent 

to participate in the pilot registry. The 

Organ Procurement and Transplantation 

Network final rule, 42 CFR part 121, 

requires organ procurement 

organizations and transplant hospitals, 

‘‘as specified from time to time by the 

Secretary,’’ to submit to the SRTR, as 

appropriate, information regarding 

‘‘donors of organs’’ and ‘‘other 

information that the Secretary deems 

appropriate.’’ 42 CFR 121.11(b)(2). 

In 2018, a pilot living donor registry 

was implemented by the SRTR, and 

each participating transplant program 

registered all potential candidates for 

living donation who provided informed 

consent to enroll. In 2019, an updated 

version of the data collection instrument 

was approved, followed by the latest 

data collection forms which were 

approved on February 26, 2021. These 

data collection modifications were 

intended to improve the quality of the 

data and reduce the administrative 

burden for respondents. This Federal 

Register notice requests an extension of 

the last approved data collection forms 

(February 2021) with no changes to the 

total estimated annualized burden 

hours. 

Need and Proposed Use of the 

Information: The transplant programs 

submit health information collected at 

the time of donation evaluation through 

a secure web-based data collection tool 

developed by the SRTR contractor. The 

SRTR contractor maintains contact with 

registry participants and collects data on 

long-term health outcomes through 

surveys. The data collection includes 

outcomes of evaluation, including 

reasons for non-donation. The living 

donor registry is an ongoing effort, and 

the goal is to continue to collect data on 

living organ donor transplant programs 

in the United States over time. 

Monitoring and reporting of long-term 

health outcomes of living organ donors 

post-donation will continue to provide 

useful information to transplant 

programs for their future donor 

selection process and to aid potential 

living organ donors in their decision to 

pursue living donation. 

Likely Respondents: Potential and 

actual living donors, transplant 

programs, medical and scientific 

organizations, and public organizations, 

including patient advocacy groups. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Average 

number of 

responses per 

respondent 

Total 

number of 

responses 

Average 

burden per 

response 

(in minutes) 

Total 

burden 

hours 

Potential Living Donor Registration form ............................................. a 16 112 1,792 0.27 484 

Potential Living Donor Follow-up form ................................................ b 754 1 754 0.50 377 

Reasons Did not Donate form (liver or kidney) ................................... a 16 106 1,696 0.23 390 


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