40574 Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 

C. How much will this fee be? 

The fee is based on the number of 

direct hours spent on taking action in 

response to the firm’s failure to comply 

with a recall order. Types of activities 

could include conducting recall audit 

checks, reviewing periodic status 

reports, analyzing the status reports and 

the results of the audit checks, 

conducting inspections, traveling to and 

from locations, and monitoring product 

disposition. The direct hours spent on 

each such recall will be billed at the 

appropriate hourly rate shown in table 

2 of this document. 

V. How must the fees be paid? 

An invoice will be sent to the 

responsible party for paying the fee after 

FDA completes the work on which the 

invoice is based. Payment must be made 

within 30 days of the invoice date in 

U.S. currency by check, bank draft, or 

U.S. postal money order payable to the 

order of the Food and Drug 

Administration. Detailed payment 

information will be included with the 

invoice when it is issued. 

VI. What are the consequences of not 

paying these fees? 

Under section 743(e)(2) of the FD&C 

Act, any fee that is not paid within 30 

days after it is due shall be treated as a 

claim of the U.S. Government subject to 

provisions of subchapter II of chapter 37 

of title 31, United States Code. 

Dated: July 20, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16056 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–2007–D–0369] 

Product-Specific Guidance for 

Olodaterol Hydrochloride; Tiotropium 

Bromide; Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Draft 

Guidance for Olodaterol Hydrochloride; 

Tiotropium Bromide.’’ The draft 

guidance, when finalized, will provide 

product-specific recommendations on, 

among other things, the information and 

data needed to demonstrate 

bioequivalence (BE) to support 

abbreviated new drug applications 

(ANDAs) for olodaterol hydrochloride; 

tiotropium bromide inhalation spray. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by September 27, 2021 to ensure that 

the Agency considers your comment on 

this draft guidance before it begins work 

on the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

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 No. FDA– 

2007–D–0369 for ‘‘Draft Guidance for 

Olodaterol Hydrochloride; Tiotropium 

Bromide.’’ Received comments 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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 


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Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 40575 

1For the reasons explained in the third-party 

certification final rule (80 FR 74570 at 74578– 

74579, November 27, 2015), and for consistency 

with the implementing regulations for the thirdparty certification program in 21 CFR parts 1, 11, 

and 16, this notice uses the term ‘‘third-party 

certification body’’ rather than the term ‘‘third-party 

auditor’’ used in section 808(a)(3) of the FD&C Act. 

FOR FURTHER INFORMATION CONTACT: 

Christine Le, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 4714, Silver Spring, 

MD 20993–0002, 301–796–2398 and/or 

PSG-Questions@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 11, 

2010 (75 FR 33311), FDA announced the 

availability of a guidance for industry 

entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products,’’ which explained the process 

that would be used to make productspecific guidances available to the 

public on FDA’s website at https://

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

guidances-drugs. 

As described in that guidance, FDA 

adopted this process to develop and 

disseminate product-specific guidances 

and to provide a meaningful 

opportunity for the public to consider 

and comment on the guidances. This 

notice announces the availability of a 

draft guidance on a generic olodaterol 

hydrochloride; tiotropium bromide 

inhalation spray. 

FDA initially approved new drug 

application (NDA) 206756 for STIOLTO 

RESPIMAT (olodaterol hydrochloride; 

tiotropium bromide inhalation spray) in 

May 2015. We are now issuing draft 

guidance for industry on BE 

recommendations for generic olodaterol 

hydrochloride; tiotropium bromide 

inhalation spray (‘‘Draft Guidance for 

Olodaterol Hydrochloride; Tiotropium 

Bromide’’). 

In October 2012, Boehringer 

Ingelheim, manufacturer of the 

reference listed drug SPIRIVA 

HANDIHALER, NDA 21395, submitted a 

citizen petition requesting, among other 

things, that FDA adopt and apply 

certain requirements in its review of any 

proposed generic and follow-on 

versions of SPIRIVA HANDIHALER or 

any other Boehringer Ingelheim oral 

inhalation product containing the active 

ingredient tiotropium bromide under 

section 505(j) and (b)(2), respectively, of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 355(j) and (b)(2)) (Docket 

No. FDA–2012–P–1072). Boehringer 

Ingelheim submitted a supplement to 

the citizen petition in January 2021 

further expanding on its initial petition 

requests. FDA is reviewing the issues 

raised in the petition and supplement 

and will consider any comments on the 

draft guidance entitled ‘‘Draft Guidance 

for Olodaterol Hydrochloride; 

Tiotropium Bromide’’ before responding 

to Boehringer’s citizen petition. 

The draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on the information and data to 

demonstrate BE to support ANDAs for 

tiotropium bromide inhalation spray. It 

does not establish any rights for any 

person and is not binding on FDA or the 

public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. 

II. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

draft guidance contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

III. 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: July 20, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16046 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–0702] 

Food Safety Modernization Act ThirdParty Certification Program User Fee 

Rate 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 annual fee rate for 

recognized accreditation bodies and 

accredited certification bodies, and the 

initial and renewal fee rate for 

accreditation bodies applying to be 

recognized in the third-party 

certification program that is authorized 

by the Federal Food, Drug, and 

Cosmetic Act (FD&C Act), as amended 

by the FDA Food Safety Modernization 

Act (FSMA). We are also announcing 

the fee rate for certification bodies that 

are applying to be directly accredited by 

FDA. 

DATES: This fee is effective October 1, 

2021. 

FOR FURTHER INFORMATION CONTACT: 

Donald Prater, Office of Food Policy and 

Response, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 3202, Silver Spring, 

MD 20993, 301–348–3007. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 307 of FSMA (Pub. L. 111– 

353), Accreditation of Third-Party 

Auditors, amended the FD&C Act to 

create a new provision, section 808, 

under the same name. Section 808 of the 

FD&C Act (21 U.S.C. 384d) directs FDA 

to establish a program for accreditation 

of third-party certification bodies 1

conducting food safety audits and 

issuing food and facility certifications to 

eligible foreign entities (including 

registered foreign food facilities) that 

meet our applicable requirements. 

Under this provision, we established a 

system for FDA to recognize 

accreditation bodies to accredit 

certification bodies, except for limited 

circumstances in which we may directly 

accredit certification bodies to 

participate in the third-party 

certification program. 

Section 808(c)(8) of the FD&C Act 

directs FDA to establish a 

reimbursement (user fee) program by 

which we assess fees and require 

reimbursement for the work FDA 

performs to establish and administer the 

third-party certification program under 

section 808 of the FD&C Act. The user 

fee program for the third-party 

certification program was established by 

a final rule entitled ‘‘Amendments to 

Accreditation of Third-Party 

Certification Bodies To Conduct Food 

Safety Audits and To Issue 

Certifications To Provide for the User 

Fee Program’’ (81 FR 90186, December 

14, 2016). 

The FSMA FY 2022 third-party 

certification program user fee rate 

announced in this notice is effective on 

October 1, 2021 and will remain in 

effect through September 30, 2022. 


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