Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 40571 

1The term ‘‘food’’ for purposes of this document 

has the same meaning as such term in section 201(f) 

of the FD&C Act (21 U.S.C. 321(f)). 

days after FDA grants the sponsor’s 

request for a BPD meeting for that 

product or upon the date of submission 

by the sponsor of an IND describing an 

investigation that FDA determines is 

intended to support a biosimilar 

biological product application for that 

product. 

The application fee for a biosimilar 

biological product is due upon 

submission of the application (see 

section 744H(a)(2)(C) of the FD&C Act). 

To make a payment of the initial BPD, 

reactivation, or application fee, 

complete the Biosimilar User Fee Cover 

Sheet, available on FDA’s website 

(https://www.fda.gov/bsufa) and 

generate a user fee identification (ID) 

number. Payment must be made in U.S. 

currency by electronic check, check, 

bank draft, U.S. postal money order, or 

wire transfer. The preferred payment 

method is online using electronic check 

(Automated Clearing House (ACH) also 

known as eCheck) or credit card 

(Discover, VISA, MasterCard, American 

Express). FDA has partnered with the 

U.S. Department of the Treasury to use 

Pay.gov, a web-based payment 

application, for online electronic 

payment. The Pay.gov feature is 

available on the FDA website after the 

user fee ID number is generated. Secure 

electronic payments can be submitted 

using the User Fees Payment Portal at 

https://userfees.fda.gov/pay (Note: Only 

full payments are accepted. No partial 

payments can be made online). Once 

you search for your invoice, click ‘‘Pay 

Now’’ to be redirected to Pay.gov. 

Electronic payment options are based on 

the balance due. Payment by credit card 

is available for balances that are less 

than $25,000. If the balance exceeds this 

amount, only the ACH option is 

available. Payments must be made using 

U.S. bank accounts as well as U.S. credit 

cards. 

If a check, bank draft, or postal money 

order is submitted, make it payable to 

the order of the Food and Drug 

Administration and include the user fee 

ID number to ensure that the payment 

is applied to the correct fee(s). Payments 

can be mailed to: Food and Drug 

Administration, P.O. Box 979108, St. 

Louis, MO 63197–9000. If a check, bank 

draft, or money order is to be sent by a 

courier that requests a street address, 

the courier should deliver your payment 

to: U.S. Bank, Attention: Government 

Lockbox 979108, 1005 Convention 

Plaza, St. Louis, MO 63101. (Note: This 

U.S. Bank address is for courier delivery 

only. If you have any questions 

concerning courier delivery, contact 

U.S. Bank at 314–418–4013. This 

telephone number is only for questions 

about courier delivery.) Please make 

sure that the FDA post office box 

number (P.O. Box 979108) and ID 

number is written on the check, bank 

draft, or postal money order. 

For payments made by wire transfer, 

include the unique user fee ID number 

to ensure that the payment is applied to 

the correct fee(s). Without the unique 

user fee ID number, the payment may 

not be applied. The originating financial 

institution may charge a wire transfer 

fee. Include applicable wire transfer fees 

with payment to ensure fees are fully 

paid. Questions about wire transfer fees 

should be addressed to the financial 

institution. The following account 

information should be used to send 

payments by wire transfer: U.S. 

Department of the Treasury, TREAS 

NYC, 33 Liberty St., New York, NY 

10045, Acct. No.: 75060099, Routing 

No.: 021030004, SWIFT: FRNYUS33. 

FDA’s tax identification number is 53– 

0196965. 

B. Annual BPD and Program Fees 

FDA will issue invoices with payment 

instructions for FY 2022 annual BPD 

and program fees under the new fee 

schedule in August 2021. Payment will 

be due on October 1, 2021. If sponsors 

join the BPD program after the annual 

BPD invoices have been issued in 

August 2021, FDA will issue invoices in 

December 2021 to firms subject to fees 

for FY 2022 that qualify for the annual 

BPD fee after the August 2021 billing. 

FDA will issue invoices in December 

2021 for any annual program fees for FY 

2022 that qualify for fee assessments 

and were not issued in August 2021. 

Dated: July 23, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16084 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–0701] 

Food Safety Modernization Act 

Domestic and Foreign Facility 

Reinspection, Recall, and Importer 

Reinspection 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 or Agency) is 

announcing the fiscal year (FY) 2022 fee 

rates for certain domestic and foreign 

facility reinspections, failures to comply 

with a recall order, and importer 

reinspections that are authorized by the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act), as amended by the FDA 

Food Safety Modernization Act (FSMA). 

These fees are effective on October 1, 

2021, and will remain in effect through 

September 30, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Jimmy Carlton, Office of Management, 

Office of Regulatory Affairs, Food and 

Drug Administration, 12420 Parklawn 

Dr., Rockville, MD 20857,240–888– 

1556,jimmy.carlton@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 107 of FSMA (Pub. L. 111– 

353) added section 743 to the FD&C Act 

(21 U.S.C. 379j–31) to provide FDA with 

the authority to assess and collect fees 

from, in part: (1) The responsible party 

for each domestic facility and the U.S. 

agent for each foreign facility subject to 

a reinspection, to cover reinspectionrelated costs; (2) the responsible party 

for a domestic facility and an importer 

who does not comply with a recall 

order, to cover food 1 recall activities 

associated with such order; and (3) each 

importer subject to a reinspection to 

cover reinspection-related costs 

(sections 743(a)(1)(A), (B), and (D) of the 

FD&C Act). Section 743 of the FD&C Act 

directs FDA to establish fees for each of 

these activities based on an estimate of 

100 percent of the costs of each activity 

for each year (sections 743(b)(2)(A)(i), 

(ii), and (iv)), and these fees must be 

made available solely to pay for the 

costs of each activity for which the fee 

was incurred (section 743(b)(3)). These 

fees are effective on October 1, 2021, 

and will remain in effect through 

September 30, 2022. Section 

743(b)(2)(B)(iii) of the FD&C Act directs 

FDA to develop a proposed set of 

guidelines in consideration of the 

burden of fee amounts on small 

businesses. As a first step in developing 

these guidelines, FDA invited public 

comment on the potential impact of the 

fees authorized by section 743 of the 

FD&C Act on small businesses (76 FR 

45818, August 1, 2011). The comment 

period for this request ended November 

30, 2011. As stated in FDA’s September 

2011 ‘‘Guidance for Industry: 

Implementation of the Fee Provisions of 

Section 107 of the FDA Food Safety 

Modernization Act,’’ (https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/ 

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40572 Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 

provisions-section-107-fda-food-safetymodernization-act), because FDA 

recognizes that for small businesses the 

full cost recovery of FDA reinspection 

or recall oversight could impose severe 

economic hardship, FDA intends to 

consider reducing certain fees for those 

firms. FDA does not intend to issue 

invoices for reinspection or recall order 

fees until FDA publishes a guidance 

document outlining the process through 

which firms may request a reduction in 

fees. 

In addition, as stated in the 

September 2011 Guidance, FDA is in 

the process of considering various 

issues associated with the assessment 

and collection of importer reinspection 

fees. The fee rates set forth in this notice 

will be used to determine any importer 

reinspection fees assessed in FY 2022. 

II. Estimating the Average Cost of a 

Supported Direct FDA Work Hour for 

FY 2022 

FDA is required to estimate 100 

percent of its costs for each activity in 

order to establish fee rates for FY 2022. 

In each year, the costs of salary (or 

personnel compensation) and benefits 

for FDA employees account for between 

50 and 60 percent of the funds available 

to, and used by, FDA. Almost all of the 

remaining funds (operating funds) 

available to FDA are used to support 

FDA employees for paying rent, travel, 

utility, information technology (IT), and 

other operating costs. 

A. Estimating the Full Cost per Direct 

Work Hour in FY 2022 

Full-time Equivalent (FTE) reflects the 

total number of regular straight-time 

hours—not including overtime or 

holiday hours—worked by employees, 

divided by the number of compensable 

hours applicable to each fiscal year. 

Annual leave, sick leave, compensatory 

time off, and other approved leave 

categories are considered ‘‘hours 

worked’’ for purposes of defining FTE 

employment. 

In general, the starting point for 

estimating the full cost per direct work 

hour is to estimate the cost of an FTE 

or paid staff year. Calculating an 

Agency-wide total cost per FTE requires 

three primary cost elements: Payroll, 

non-payroll, and rent. 

We have used an average of past year 

cost elements to predict the FY 2022 

cost. The FY 2022 FDA-wide average 

cost for payroll (salaries and benefits) is 

$171,228; non-payroll—including 

equipment, supplies, IT, general and 

administrative overhead—is $101,625; 

and rent, including cost allocation 

analysis and adjustments for other rent 

and rent-related costs, is $23,597 per 

paid staff year, excluding travel costs. 

Summing the average cost of an FTE 

for payroll, non-payroll, and rent, brings 

the FY 2022 average fully supported 

cost to $296,450 per FTE, excluding 

travel costs. FDA will use this base unit 

fee in determining the hourly fee rate for 

reinspection and recall order fees for FY 

2022 prior to including domestic or 

foreign travel costs as applicable for the 

activity. 

To calculate an hourly rate, FDA must 

divide the FY 2022 average fully 

supported cost of $296,450 per FTE by 

the average number of supported direct 

FDA work hours in FY 2020—the last 

fiscal year for which data are available. 

See table 1. 

TABLE 1—SUPPORTED DIRECT FDA 

WORK HOURS IN A PAID STAFF

YEAR IN FY 2020 

Total number of hours in a paid staff year ... 2,080 

Less: 

10 paid holidays ........................................ ¥80 

20 days of annual leave ............................ ¥160 

10 days of sick leave ................................. ¥80 

12.5 days of training .................................. ¥100 

26.5 days of general administration .......... ¥184 

26.5 days of travel ..................................... ¥212 

2 hours of meetings per week ................... ¥104 

Net Supported Direct FDA Work Hours 

Available for Assignments ..................... 1,160 

Dividing the average fully supported 

FTE cost in FY 2022 ($296,450) by the 

total number of supported direct work 

hours available for assignment in FY 

2022 (1,160) results in an average fully 

supported cost of $256 (rounded to the 

nearest dollar), excluding inspection 

travel costs, per supported direct work 

hour in FY 2022. 

B. Adjusting FY 2020 Travel Costs for 

Inflation To Estimate FY 2022 Travel 

Costs 

To adjust the hourly rate for FY 2022, 

FDA must estimate the cost of inflation 

in each year for FY 2021 and FY 2022. 

FDA uses the method prescribed for 

estimating inflationary costs under the 

Prescription Drug User Fee Act 

(PDUFA) provisions of the FD&C Act 

(section 736(c)(1) (21 U.S.C. 379h(c)(1)), 

the statutory method for inflation 

adjustment in the FD&C Act that FDA 

has used consistently. FDA previously 

determined the FY 2021 inflation rate to 

be 1.3493 percent; this rate was 

published in the FY 2021 PDUFA user 

fee rates notice in the Federal Register 

(August 3, 2020, 85 FR 46651). Utilizing 

the method set forth in section 736(c)(1) 

of the FD&C Act, FDA has calculated an 

inflation rate of 1.3493 percent for FY 

2021 and 2.2013 percent for FY 2022, 

and FDA intends to use these inflation 

rates to make inflation adjustments for 

FY 2022 for several of its user fee 

programs; the derivation of this rate will 

be published in the Federal Register in 

the FY 2022 notice for the PDUFA user 

fee rates. 

The average fully supported cost per 

supported direct FDA work hour, 

excluding travel costs, of $256 already 

takes into account inflation as the 

calculation above is based on FY 2022 

predicted costs. FDA will use this base 

unit fee in determining the hourly fee 

rate for reinspection and recall order 

fees for FY 2022 prior to including 

domestic or foreign travel costs as 

applicable for the activity. In FY 2020, 

FDA’s Office of Regulatory Affairs 

(ORA) spent a total of $3,831,758 for 

domestic regulatory inspection travel 

costs and General Services 

Administration Vehicle costs related to 

FDA’s Center for Food Safety and 

Applied Nutrition (CFSAN) and Center 

for Veterinary Medicine (CVM) field 

activities programs. The total ORA 

domestic travel costs spent is then 

divided by the 4,399 CFSAN and CVM 

domestic inspections, which averages a 

total of $871 per inspection. These 

inspections average 42.65 hours per 

inspection. Dividing $871 per 

inspection by 42.65 hours per 

inspection results in a total and an 

additional cost of $20 (rounded to the 

nearest dollar) per hour spent for 

domestic inspection travel costs in FY 

2020. To adjust for the $20 per hour 

additional domestic cost inflation 

increases for FY 2021 and FY 2022, FDA 

must multiply the FY 2021 PDUFA 

inflation rate adjustor (1.013493) times 

the FY 2022 PDUFA inflation rate 

adjustor (1.022013) times the $20 

additional domestic cost, which results 

in an estimated cost of $21 (rounded to 

the nearest dollar) per paid hour in 

addition to $256 for a total of $277 per 

paid hour ($256 plus $21) for each 

direct hour of work requiring domestic 

inspection travel. FDA will use these 

rates in charging fees in FY 2022 when 

domestic travel is required. 

In FY 2020, ORA spent a total of 

$1,449,058 on 171 foreign inspection 

trips related to FDA’s CFSAN and CVM 

field activities programs, which 

averaged a total of $8,474 per foreign 

inspection trip. These trips averaged 3 

weeks (or 120 paid hours) per trip. 

Dividing $8,474 per trip by 120 hours 

per trip results in a total and an 

additional cost of $71 (rounded to the 

nearest dollar) per paid hour spent for 

foreign inspection travel costs in FY 

2020. To adjust $71 for inflationary 

increases in FY 2021 and FY 2022, FDA 

must multiply it by the same inflation 

factors mentioned previously in this 


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Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 40573 

document (1.013493 and 1.022013), 

which results in an estimated cost of 

$74 (rounded to the nearest dollar) per 

paid hour in addition to $256 for a total 

of $330 per paid hour ($256 plus $74) 

for each direct hour of work requiring 

foreign inspection travel. FDA will use 

these rates in charging fees in FY 2022 

when foreign travel is required. 

TABLE 2—FSMA FEE SCHEDULE FOR

FY 2022 

Fee category Fee rates for 

FY 2022 

Hourly rate if domestic travel 

is required ......................... $277 

Hourly rate if foreign travel is 

required ............................. 330 

III. Fees for Reinspections of Domestic 

or Foreign Facilities Under Section 

743(a)(1)(A) 

A. What will cause this fee to be 

assessed? 

The fee will be assessed for a 

reinspection conducted under section 

704 of the FD&C Act (21 U.S.C. 374) to 

determine whether corrective actions 

have been implemented and are 

effective and compliance has been 

achieved to the Secretary of Health and 

Human Services’ (the Secretary) (and, 

by delegation, FDA’s) satisfaction at a 

facility that manufactures, processes, 

packs, or holds food for consumption 

necessitated as a result of a previous 

inspection (also conducted under 

section 704) of this facility, which had 

a final classification of Official Action 

Indicated (OAI) conducted by or on 

behalf of FDA, when FDA determined 

the non-compliance was materially 

related to food safety requirements of 

the FD&C Act. FDA considers such noncompliance to include non-compliance 

with a statutory or regulatory 

requirement under section 402 of the 

FD&C Act (21 U.S.C. 342) and section 

403(w) of the FD&C Act (21 U.S.C. 

343(w)). However, FDA does not 

consider non-compliance that is 

materially related to a food safety 

requirement to include circumstances 

where the non-compliance is of a 

technical nature and not food safety 

related (e.g., failure to comply with a 

food standard or incorrect font size on 

a food label). Determining when noncompliance, other than under sections 

402 and 403(w) of the FD&C Act, is 

materially related to a food safety 

requirement of the FD&C Act may 

depend on the facts of a particular 

situation. FDA intends to issue guidance 

to provide additional information about 

the circumstances under which FDA 

would consider non-compliance to be 

materially related to a food safety 

requirement of the FD&C Act. 

Under section 743(a)(1)(A) of the 

FD&C Act, FDA is directed to assess and 

collect fees from ‘‘the responsible party 

for each domestic facility (as defined in 

section 415(b) (21 U.S.C. 350d(b))) and 

the United States agent for each foreign 

facility subject to a reinspection’’ to 

cover reinspection-related costs. 

Section 743(a)(2)(A)(i) of the FD&C 

Act defines the term ‘‘reinspection’’ 

with respect to domestic facilities as ‘‘1 

or more inspections conducted under 

section 704 subsequent to an inspection 

conducted under such provision which 

identified non-compliance materially 

related to a food safety requirement of 

th[e] Act, specifically to determine 

whether compliance has been achieved 

to the Secretary’s satisfaction.’’ 

The FD&C Act does not contain a 

definition of ‘‘reinspection’’ specific to 

foreign facilities. In order to give 

meaning to the language in section 

743(a)(1)(A) of the FD&C Act to collect 

fees from the U.S. agent of a foreign 

facility subject to a reinspection, the 

Agency is using the following definition 

of ‘‘reinspection’’ for purposes of 

assessing and collecting fees under 

section 743(a)(1)(A), with respect to a 

foreign facility, ‘‘1 or more inspections 

conducted by officers or employees duly 

designated by the Secretary subsequent 

to such an inspection which identified 

non-compliance materially related to a 

food safety requirement of the FD&C 

Act, specifically to determine whether 

compliance has been achieved to the 

Secretary’s (and, by delegation, FDA’s) 

satisfaction.’’ 

This definition allows FDA to fulfill 

the mandate to assess and collect fees 

from the U.S. agent of a foreign facility 

in the event that an inspection reveals 

non-compliance materially related to a 

food safety requirement of the FD&C 

Act, causing one or more subsequent 

inspections to determine whether 

compliance has been achieved to the 

Secretary’s (and, by delegation, FDA’s) 

satisfaction. By requiring the initial 

inspection to be conducted by officers 

or employees duly designated by the 

Secretary, the definition ensures that a 

foreign facility would be subject to fees 

only in the event that FDA, or an entity 

designated to act on its behalf, has made 

the requisite identification at an initial 

inspection of non-compliance materially 

related to a food safety requirement of 

the FD&C Act. The definition of 

‘‘reinspection-related costs’’ in section 

743(a)(2)(B) of the FD&C Act relates to 

both a domestic facility reinspection 

and a foreign facility reinspection, as 

described in section 743(a)(1)(A). 

B. Who will be responsible for paying 

this fee? 

The FD&C Act states that this fee is to 

be paid by the responsible party for each 

domestic facility (as defined in section 

415(b) of the FD&C Act) and by the U.S. 

agent for each foreign facility (section 

743(a)(1)(A) of the FD&C Act). This is 

the party to whom FDA will send the 

invoice for any fees that are assessed 

under this section. 

C. How much will this fee be? 

The fee is based on the number of 

direct hours spent on such 

reinspections, including time spent 

conducting the physical surveillance 

and/or compliance reinspection at the 

facility, or whatever components of 

such an inspection are deemed 

necessary, making preparations and 

arrangements for the reinspection, 

traveling to and from the facility, 

preparing any reports, analyzing any 

samples or examining any labels if 

required, and performing other activities 

as part of the OAI reinspection until the 

facility is again determined to be in 

compliance. The direct hours spent on 

each such reinspection will be billed at 

the appropriate hourly rate shown in 

table 2 of this document. 

IV. Fees for Non-Compliance With a 

Recall Order Under Section 743(a)(1)(B) 

A. What will cause this fee to be 

assessed? 

The fee will be assessed for not 

complying with a recall order under 

section 423(d) (21 U.S.C. 350l(d)) or 

section 412(f) of the FD&C Act (21 

U.S.C. 350a(f)) to cover food recall 

activities associated with such order 

performed by the Secretary (and by 

delegation, FDA) (section 743(a)(1)(B) of 

the FD&C Act). Non-compliance may 

include the following: (1) Not initiating 

a recall as ordered by FDA; (2) not 

conducting the recall in the manner 

specified by FDA in the recall order; or 

(3) not providing FDA with requested 

information regarding the recall, as 

ordered by FDA. 

B. Who will be responsible for paying 

this fee? 

Section 743(a)(1)(B) of the FD&C Act 

states that the fee is to be paid by the 

responsible party for a domestic facility 

(as defined in section 415(b) of the 

FD&C Act) and an importer who does 

not comply with a recall order under 

section 423 or under section 412(f) of 

the FD&C Act. In other words, the party 

paying the fee would be the party that 

received the recall order. 


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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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