Federal Register / Vol. 87, No. 79 / Monday, April 25, 2022 / Notices 24321 

Application No. Drug Applicant 

ANDA 075695 ...................... Butorphanol Tartrate Injection, 1 milligram (mg)/milliliter 

(mL), and 2 mg/mL.

Baxter Healthcare Corporation, One Baxter Pkwy., 

Deerfield, IL 60015. 

ANDA 075697 ...................... Butorphanol Tartrate Injection, 2 mg/mL ........................ Do. 

ANDA 077290 ...................... Oxycodone Hydrochloride (HCl) Tablets, 5 mg, 10 mg, 

15 mg, 20 mg, 30 mg.

Nesher Pharmaceuticals (USA) LLC, 13910 St. Charles 

Rock Rd., Bridgeton, MO 63044. 

ANDA 078564 ...................... Granisetron HCl Injection, Equivalent to (EQ) 1 mg 

base/mL (EQ 1 mg base/mL).

Morton Grove Pharmaceuticals Inc., 6451 Main St., 

Morton Grove, IL 60053. 

ANDA 078565 ...................... Granisetron HCl Injection, EQ 4 mg base/4 mL (EQ 1 

mg base/mL).

Do. 

ANDA 078566 ...................... Granisetron HCl Injection, EQ 0.1 mg base/mL (EQ 0.1 

mg base/mL).

Do. 

ANDA 088342 ...................... Fluoxymesterone Tablets, 10 mg ................................... Upsher-Smith Laboratories, LLC, 6701 Evenstad Dr., 

Maple Grove, MN 55369. 

ANDA 202032 ...................... Lamivudine Tablets, 150 mg and 300 mg ...................... Aurobindo Pharma USA, Inc., 279 PrincetonHightstown Rd., East Windsor, NJ 08520. 

ANDA 205322 ...................... Efavirenz Tablets, 600 mg .............................................. Do. 

ANDA 205690 ...................... Choline C–11 Injection, 4–100 millicurie/mL .................. University of Texas MD Anderson Cancer Center, 1881 

East Rd., Unit 1903, Houston, TX 77054. 

ANDA 207653 ...................... Rosuvastatin Calcium Tablets, EQ 5 mg base, EQ 10 

mg base, EQ 20 mg base, EQ 40 mg base.

SciRegs International, Inc., 6333 Summercrest Dr., Columbia, MD 21045. 

ANDA 208199 ...................... Azelastine HCl Metered Spray, 0.2055 mg/spray .......... Amneal Pharmaceuticals LLC, 50 Horseblock Rd., 

Brookhaven, NY 11719. 

ANDA 210032 ...................... Azelastine HCl Metered Spray, 0.2055 mg/spray .......... Akorn Operating Company LLC, 1925 West Field Ct., 

Suite 300, Lake Forest, IL 60045. 

ANDA 211461 ...................... Bosentan Tablets, 62.5 mg and 125 mg ........................ Syneos Health Global Headquarters, 1030 Sync St., 

Third Floor, Morrisville, NC 27560. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of May 25, 2022. 

Approval of each entire application is 

withdrawn, including any strengths and 

dosage forms inadvertently missing 

from the table. Introduction or delivery 

for introduction into interstate 

commerce of products without 

approved new drug applications 

violates section 301(a) and (d) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 331(a) and (d)). Drug 

products that are listed in the table that 

are in inventory on May 25, 2022 may 

continue to be dispensed until the 

inventories have been depleted or the 

drug products have reached their 

expiration dates or otherwise become 

violative, whichever occurs first. 

Dated: April 19, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08744 Filed 4–22–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0801] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Export Notification 

and Recordkeeping Requirements 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) 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 May 25, 

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 0910–0482. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Showalter, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 240–994–7399, 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. 

Export Notification and Recordkeeping 

Requirements 

OMB Control Number 0910–0482— 

Extension 

Sections 801 and 802 of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 381 and 382) charge the 

Secretary of Health and Human 

Services, through FDA, with the 

responsibility of helping to ensure that 

exports of unapproved new drugs, 

biologics, devices, animal drugs, food, 

cosmetics, and tobacco products that are 

not to be sold in the United States meet 

the requirements of the country to 

which the product is to be exported. 

The respondents to this information 

collection are exporters who have 

notified FDA of their intent to export 

unapproved products that may not be 

sold or offered for sale in domestic 

commerce in the United States as 

allowed under section 801(e) of the 

FD&C Act. In general, the notification 


khammond on DSKJM1Z7X2PROD with NOTICES
24322 Federal Register / Vol. 87, No. 79 / Monday, April 25, 2022 / Notices 

identifies the product being exported 

(e.g., name, description, and in some 

cases, country of destination) and 

specifies where the notifications were 

sent. These notifications are sent only 

for an initial export. Subsequent exports 

of the same product to the same 

destination or to certain countries 

identified in section 802(b) of the FD&C 

Act would not result in a notification to 

FDA. 

Respondents to the information 

collection are exporters of products that 

may not be sold in the United States and 

are regulated by FDA’s Center for Drug 

Evaluation and Research (CDER); Center 

for Biologics Evaluation and Research 

(CBER); Center for Devices and 

Radiological Health (CDRH); Center for 

Veterinary Medicine (CVM); Center for 

Food Safety and Applied Nutrition 

(CFSAN); and Center for Tobacco 

Products. Respondents to this collection 

of information maintain records 

demonstrating their compliance with 

the requirements in 21 CFR 1.101. 

In the Federal Register of January 25, 

2022 (87 FR 3811), FDA published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. No comments were 

received. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

1.101(d) (CBER) .................................................................. 4 35 140 15 2,100 

1.101(d) (CDER) .................................................................. 3 57 171 15 2,565 

1.101(d) (CDRH) .................................................................. 22 4 88 15 1,320 

Total .............................................................................. ........................ ........................ ........................ ........................ 5,985 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

1.101(b), (c), and (e) (CBER, CDER, CDRH, CFSAN, and 

CVM) ................................................................................ 181 4.12 746 22 16,412 

1.101(b) Office of International Programs only ................... 1 65 65 22 1,430 

1.101(b) (currently regulated Tobacco Products) ................ 322 3 966 22 21,252 

Total .............................................................................. ........................ ........................ ........................ ........................ 39,094 

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

Based on a review of Agency data, we 

decreased our estimate by 24,251 

burden hours. This decrease reflects an 

overall downward trend in the number 

of export certification requests across 

programs and commodities. The 

estimate for tobacco products remains 

steady. 

Dated: April 19, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08739 Filed 4–22–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Special 

Topics: Vision Imaging, Bioengineering and 

Low Vision Technology Development. 

Date: May 25–26, 2022. 

Time: 9:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Susan Gillmor, Ph.D., 

Scientific Review Officer, National Institutes 

of Health, Center for Scientific Review, 6701 

Rockledge Drive, Bethesda, MD 20892, 240– 

762–3076, susan.gillmor@nih.gov. 

Name of Committee: Bioengineering 

Sciences & Technologies Integrated Review 

Group; Gene and Drug Delivery Systems 

Study Section. 

Date: June 13–14, 2022. 

Time: 9:00 a.m. to 8:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Jain Krotz, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, MD 

20892, (240) 672–8670 jain.krotz@nih.gov. 

Name of Committee: Vascular and 

Hematology Integrated Review Group; 

Hemostasis, Thrombosis, Blood Cells and 

Transfusion Study Section. 

Date: June 14–15, 2022. 

Time: 10:00 a.m. to 9:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Katherine M Malinda, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4140, 

MSC 7814, Bethesda, MD 20892, (301) 435– 

0912, malindakm@csr.nih.gov. 

Name of Committee: Bioengineering 

Sciences & Technologies Integrated Review 

Group; Instrumentation and Systems 

Development Study Section. 


khammond on DSKJM1Z7X2PROD with NOTICES