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Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Notices
records regarding clinical investigators, including protocol agreements and investigator resumes or curriculum
vitae. FDA estimates than an average of 15 minutes will be required for each
recordkeeper to add this record to the clinical investigators file.

TABLE 3ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR section
Number of recordkeepers
Number of records per recordkeeper
Total annual records
Average burden per recordkeeping
Total hours 2

Recordkeeping54.6

715

1

715

0.25

179

1 There 2

are no capital costs or operating and maintenance costs associated with this collection of information.
Numbers have been rounded.

Third-Party Disclosure Burden Under 54.4b, clinical investigators supply to the sponsor of a covered study financial information sufficient to allow the sponsor to submit complete and accurate certification or disclosure
statements. Clinical investigators are accustomed to supplying such information when applying for research grants. Also, most people know the financial holdings of their immediate family and records of such interests are generally accessible because they are
needed for preparing tax records. For these reasons, FDA estimates that the time required for this task may range from 5 to 15 minutes; we used the median, 10 minutes, for the average burden per disclosure see table 1.

TABLE 4ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
21 CFR section
Number of respondents
Number of disclosures per respondent
Total annual disclosures
Average burden per disclosure
Total hours 2

54.4bClinical Investigators

13,082

1

13,082

0.17

2,224

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

2 Numbers
The burden for this information collection request has changed since the last OMB approval. Our estimated burden for the information collection reflects a 298 hour increase. We have adjusted our estimated burden for the information collection to reflect the number of submissions we received in the last few years. Additionally, for products regulated by the Center for Devices and Radiological Health, we now include De Novo requests as a type of application that may rely on clinical studies. For products regulated by the Center for Drug Evaluation and Research, we now include biologics license applications BLAs and BLA
efficacy supplements that were inadvertently excluded from our last information collection request as a type of application.

Food and Drug Administration Docket No. FDA2021N1145

Aurolife Pharma LLC, et al.;
Withdrawal of Approval of Five Abbreviated New Drug Applications AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice.

Dated: November 24, 2021.
Lauren K. Roth, Associate Commissioner for Policy.

The Food and Drug Administration FDA or Agency is withdrawing approval of five abbreviated new drug applications ANDAs from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

FR Doc. 202126182 Filed 12121; 8:45 am
DATES:

BILLING CODE 416401P

lotter on DSK11XQN23PROD with NOTICES1

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

SUMMARY:

FOR FURTHER INFORMATION CONTACT:

Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 209930002, 240
4026980, Martha.Nguyen@fda.hhs.gov.
The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in 314.150c 21 CFR
314.150c. The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under 314.150c is without prejudice to refiling.

SUPPLEMENTARY INFORMATION:

Approval is withdrawn as of January 3, 2022.

Application No.

Drug
Applicant
ANDA 072514

Clorazepate Dipotassium Tablets, 3.75 milligrams mg, 7.5
mg, and 15 mg.
Ondansetron Hydrochloride Injection, Equivalent to EQ 2
mg base/milliliters mL.
Fluconazole in Dextrose 5% Injection, 200 mg/100 mL 2 mg/
mL and 400 mg/200 mL 2 mg/mL.

Aurolife Pharma LLC, 2400 U.S. Hwy. 130 N, Dayton, NJ
08810.
Hospira, Inc., 275 N Field Dr., Bldg. H1, Lake Forest, IL
60045.
Woodward Pharma Services LLC, 47220 Cartier Dr., Wixom, MI 48393.

ANDA 077840
ANDA 077988

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