Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 40587 

1See 79 FR 22501 (April 22, 2014). 

wire transfer: U.S. Department of the 

Treasury, TREAS NYC, 33 Liberty St., 

New York, NY 10045, account number: 

75060099, routing number: 021030004, 

SWIFT: FRNYUS33. FDA’s tax 

identification number is 53–0196965. 

Dated: July 20, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16039 Filed 7–27–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0649] 

Determination That CECLOR CD 

(Cefaclor Extended-Release Tablets) 

375 Milligrams and 500 Milligrams 

Were Not Withdrawn From Sale for 

Reasons of Safety or Effectiveness, 

Except the Indication of Secondary 

Bacterial Infections of Acute 

Bronchitis, Which Was Withdrawn 

From Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 

has determined that CECLOR CD 

(cefaclor extended-release tablets) 375 

milligrams (mg) and 500 mg were not 

withdrawn from sale for reasons of 

safety or effectiveness, except with 

respect to the indication of secondary 

bacterial infections of acute bronchitis 

(SBIAB) that was withdrawn for reasons 

of safety or effectiveness. This 

determination means that FDA will not 

begin procedures to suspend approval of 

any abbreviated new drug application 

(ANDA) that refers to this drug product 

and has removed the indication for 

SBIAB. This determination also will 

allow FDA to continue to approve 

ANDAs that refer to these drug products 

as long as they meet relevant legal and 

regulatory requirements. However, the 

Agency will not accept or approve 

ANDAs for CECLOR CD (cefaclor 

extended-release tablets) 375 mg and 

500 mg that include SBIAB as an 

indication. 

FOR FURTHER INFORMATION CONTACT: 

Stacy Kane, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6236, Silver Spring, 

MD 20993–0002, 301–796–8363, 

Stacy.Kane@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 

approving 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. 

Under § 314.161(a)(2), the Agency 

must also determine whether a listed 

drug was withdrawn from sale for 

reasons of safety or effectiveness if 

ANDAs that referred to the listed drug 

have already been approved prior to its 

market withdrawal. If the Agency 

determines that a listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness, and there are 

approved ANDAs that reference that 

listed drug, FDA will initiate a 

proceeding to determine whether the 

suspension of the ANDAs is also 

required (21 CFR 314.161(d)). 

CECLOR CD (cefaclor extendedrelease tablets) 375 mg and 500 mg are 

the subject of NDA 050673 held by Eli 

Lilly and Co., and initially approved on 

June 28, 1996. CECLOR CD (cefaclor 

extended-release tablets) is indicated for 

the treatment of patients with the 

following mild to moderate infections 

when caused by susceptible strains of 

the designated microorganisms: 

• Acute bacterial exacerbations of 

chronic bronchitis due to Haemophilus 

influenzae (non-b-lactamase-producing 

strains only), Moraxella catarrhalis 

(including b-lactamase-producing 

strains) or Streptococcus pneumoniae. 

• Secondary bacterial infections of 

acute bronchitis due to H. influenzae 

(non-b-lactamase-producing strains 

only), M. catarrhalis (including blactamase-producing strains), or S. 

pneumoniae. 

• Pharyngitis and tonsillitis due to 

Streptococcus pyogenes. 

• Uncomplicated skin and skin 

structure infections due to 

Staphylococcus aureus (methicillinsusceptible). 

On June 13, 2005, Eli Lilly and Co. 

submitted a request to the Agency to 

withdraw approval of NDA 050673, 

CECLOR CD (cefaclor extended-release 

tablets), 375 mg and 500 mg, under 21 

CFR 314.150(c). The Agency published 

a Federal Register notice on April 22, 

2014, withdrawing approval of NDA 

050673, effective May 22, 2014.1

After reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that CECLOR CD (cefaclor 

extended-release tablets), 375 mg and 

500 mg, were not withdrawn from sale 

for reasons of safety or effectiveness, 

except with respect to the indication for 

SBIAB. 

Based on a review of relevant 

information, FDA has concluded that 

the SBIAB indication is not appropriate 

because most cases of SBIAB are 

considered to be viral or noninfectious. 

As an antibacterial drug, CECLOR CD 

(cefaclor extended-release tablets) is not 

considered to be effective to treat 

SBIAB. Such use of CECLOR CD 

(cefaclor extended-release tablets) 

would likely result in inappropriate 

antibacterial drug use. Accordingly, for 

the treatment of SBIAB, the benefit-risk 

profile of CECLOR CD (cefaclor 

extended-release tablets) is unfavorable 

and does not support approval of these 

products (or ANDAs referencing them) 

for this indication. For the remaining 

indications, the Agency has determined 

that CECLOR CD (cefaclor extendedrelease tablets) continues to have a 

favorable benefit-risk profile. 

Accordingly, the Agency will 

continue to list CECLOR CD (cefaclor 

extended-release tablets), 375 mg and 

500 mg, in the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. The approved ANDA has 


khammond on DSKJM1Z7X2PROD with NOTICES
40588 Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 

removed the SBIAB indication from its 

labeling, consistent with this decision. 

In addition, FDA will continue to accept 

and, where appropriate, approve 

ANDAs that refer to CECLOR CD 

(cefaclor extended-release tablets) as 

long as they meet relevant legal and 

regulatory requirements, but FDA will 

not accept or approve ANDAs that refer 

to this drug product and propose to 

include the SBIAB indication. 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 20, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16050 Filed 7–27–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0698] 

Outsourcing Facility Fee Rates for 

Fiscal Year 2022 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

fiscal year (FY) 2022 rates for the 

establishment and reinspection fees 

related to entities that compound 

human drugs and elect to register as 

outsourcing facilities under the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act). The FD&C Act authorizes FDA to 

assess and collect an annual 

establishment fee from outsourcing 

facilities, as well as a reinspection fee 

for each reinspection of an outsourcing 

facility. This document establishes the 

FY 2022 rates for the small business 

establishment fee ($5,824), the nonsmall business establishment fee 

($18,999), and the reinspection fee 

($17,472) for outsourcing facilities; 

provides information on how the fees 

for FY 2022 were determined; and 

describes the payment procedures 

outsourcing facilities should follow. 

These fee rates are effective October 1, 

2021, and will remain in effect through 

September 30, 2022. 

FOR FURTHER INFORMATION CONTACT: For 

more information on human drug 

compounding and outsourcing facility 

fees: Visit FDAs website at: https://

www.fda.gov/Drugs/ 

GuidanceCompliance

RegulatoryInformation/ 

PharmacyCompounding/default.htm. 

For questions relating to this notice: 

Melissa Hurley, Office of Financial 

Management, Food and Drug 

Administration, 4041 Powder Mill Rd., 

Rm. 61075, Beltsville, MD 20705–4304, 

240–402–4585. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under section 503B of the FD&C Act 

(21 U.S.C. 353b), a human drug 

compounder can become an 

‘‘outsourcing facility.’’ Outsourcing 

facilities, as defined in section 

503B(d)(4), are facilities that meet all 

the conditions described in section 

503B(a), including registering with FDA 

as an outsourcing facility and paying an 

annual establishment fee. If the 

conditions of section 503B are met, a 

drug compounded by or under the 

direct supervision of a licensed 

pharmacist in an outsourcing facility is 

exempt from three sections of the FD&C 

Act: (1) Section 502(f)(1) (21 U.S.C. 

352(f)(1)) concerning the labeling of 

drugs with adequate directions for use; 

(2) section 505 (21 U.S.C. 355) 

concerning the approval of human drug 

products under new drug applications 

(NDAs) or abbreviated new drug 

applications (ANDAs); and (3) section 

582 (21 U.S.C. 360eee–1) concerning 

drug supply chain security 

requirements. Drugs compounded in 

outsourcing facilities are not exempt 

from the requirements of section 

501(a)(2)(B) of the FD&C Act (21 U.S.C. 

351(a)(2)(B)) concerning current good 

manufacturing practice requirements for 

drugs. 

Section 744K of the FD&C Act (21 

U.S.C. 379j–62) authorizes FDA to 

assess and collect the following fees 

associated with outsourcing facilities: 

(1) An annual establishment fee from 

each outsourcing facility and (2) a 

reinspection fee from each outsourcing 

facility subject to a reinspection (see 

section 744K(a)(1) of the FD&C Act). 

Under statutorily defined conditions, a 

qualified applicant may pay a reduced 

small business establishment fee (see 

section 744K(c)(4) of the FD&C Act). 

FDA announced in the Federal 

Register of November 24, 2014 (79 FR 

69856), the availability of a final 

guidance for industry entitled ‘‘Fees for 

Human Drug Compounding Outsourcing 

Facilities Under Sections 503B and 

744K of the FD&C Act.’’ The guidance 

provides additional information on the 

annual fees for outsourcing facilities 

and adjustments required by law, 

reinspection fees, how to submit 

payment, the effect of failure to pay fees, 

and how to qualify as a small business 

to obtain a reduction of the annual 

establishment fee. This guidance can be 

accessed on FDA’s website at: https://

www.fda.gov/media/136683/download. 

II. Fees for FY 2022 

A. Methodology for Calculating FY 2022 

Adjustment Factors 

1. Inflation Adjustment Factor 

Section 744K(c)(2) of the FD&C Act 

specifies the annual inflation 

adjustment for outsourcing facility fees. 

The inflation adjustment has two 

components: One based on FDA’s 

payroll costs and one based on FDA’s 

non-payroll costs for the first 3 of the 4 

previous fiscal years. The payroll 

component of the annual inflation 

adjustment is calculated by taking the 

average change in FDA’s per-full time 

equivalent (FTE) personnel 

compensation and benefits (PC&B) in 

the first 3 of the 4 previous fiscal years 

(see section 744K(c)(2)(A)(ii) of the 

FD&C Act). FDA’s total annual spending 

on PC&B is divided by the total number 

of FTEs per fiscal year to determine the 

average PC&B per FTE. 

Table 1 summarizes the actual cost 

and FTE data for the specified fiscal 

years, and provides the percent change 

from the previous fiscal year and the 

average percent change over the first 3 

of the 4 fiscal years preceding FY 2022. 

The 3-year average is 2.7383 percent. 

TABLE 1—FDA PC&BS EACH YEAR AND PERCENT CHANGE

Fiscal year 2018 2019 2020 3-Year 

average 

Total PC&B .......................................................................................... $2,690,678,000 $2,620,052,000 $2,875,592,000 ........................

Total FTE ............................................................................................. 17,023 17,144 17,535 ........................

PC&B per FTE ..................................................................................... $158,061 $152,826 $163,992 ........................

Percent change from previous year .................................................... 4.2206 ¥3.3120 7.3063 2.7383 


khammond on DSKJM1Z7X2PROD with NOTICES