51898 Federal Register / Vol. 86, No. 178 / Friday, September 17, 2021 / Notices 

comprehension, reactions, and 

perceptions; and (3) adding to the 

regulatory science knowledge base. 

Quantitative studies play an important 

role in exploring areas of research and 

gathering information because they can 

be used to summarize a population of 

interest on key variables or reveal 

systematic relationships between 

variables. 

Foundational research to inform 

message development and the formative 

pretesting of messages are a staple of 

best practices in communications 

research. Obtaining voluntary feedback 

from intended audiences during the 

development of messages and materials 

is crucial for the success of every 

communication program. The purpose 

of obtaining information from formative 

pretesting is that it allows FDA to 

improve materials and strategies while 

revisions are still affordable and 

possible. Formative pretesting can also 

avoid potentially expensive and 

dangerous unintended outcomes caused 

by audiences interpreting messages in a 

way that was not intended by the 

drafters. By maximizing the 

effectiveness of messages and strategies 

for reaching targeted audiences, the 

frequency with which tobacco 

communication messages need to be 

modified should be greatly reduced. 

The voluntary information collected 

will serve the primary purpose of 

providing FDA information about 

various measures of ad performance 

including message comprehension, 

perceived effectiveness, emotional 

responses and knowledge, attitudes, and 

behavior change to assess the ability of 

messages, advertisements, and materials 

to reach and successfully communicate 

with their intended audiences. 

Quantitative testing messages and other 

materials with a sample of the target 

audience will allow FDA to refine 

messages, advertisements, and materials 

directed at consumers while the 

materials are still in the developmental 

stage. 

In addition, quantitative information 

is needed by FDA to track changes in 

response to policy and regulatory 

actions and to expand the tobacco 

regulatory science base by providing 

information on changing behaviors, 

knowledge, and attitudes about tobacco 

products, including postmarketing 

surveillance of tobacco products. 

In the Federal Register of March 5, 

2021 (86 FR 12952), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. One PRA related comment 

was received. 

(Comment) The comment suggested 

specific types of messages that FDA 

should test and then implement in 

public health campaigns. 

(Response) FDA appreciates the 

comment. The content and focus on 

studies submitted through this generic 

clearance will depend on Agency 

priorities and needs, which are not yet 

determined at this time. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

Screener ............................................................... 485,580 1 485,580 0.083 (5 minutes) ......... 40,465 

Self-Administered Surveys ................................... 133,728 1 133,728 0.33 (20 minutes) ......... 44,576 

Total ............................................................... ........................ ........................ ........................ ....................................... 85,041 

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

Number of respondents to be included 

in each new survey will vary, 

depending on the nature of the material 

or message being tested and the target 

audience. Table 1 provides examples of 

the types of activities that may be 

administered and estimated burden 

levels during the 3-year period. Time to 

read, review, or complete the activity is 

built into the ‘‘Average Burden per 

Response’’ figures. Our estimated 

burden for the information collection 

reflects an overall increase of 60,000 

hours and a corresponding increase of 

461,808 responses. We attribute the 

adjustment to an increase in the number 

of new quantitative studies that are 

anticipated underneath this information 

collection during the next 3 years 

(proposed extension). 

Dated: September 10, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–20057 Filed 9–16–21; 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 Guidances for Ferric 

Oxyhydroxide; Revised Draft 

Guidances 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 revised 

draft guidances for industry entitled 

‘‘Draft Guidance for Ferric 

Oxyhydroxide.’’ The revised draft 

guidances, when finalized, will provide 

product-specific recommendations on, 

among other things, the design of 

bioequivalence (BE) studies to support 

abbreviated new drug applications 

(ANDAs) for ferric oxyhydroxide oral 

tablets (previously sucroferric 

oxyhydroxide) and ferric oxyhydroxide 

intravenous injectable (previously iron 

sucrose). 

DATES: Submit either electronic or 

written comments on the draft 

guidances by November 16, 2021 to 

ensure that the Agency considers your 

comment on these draft guidances 

before it begins work on the final 

versions of the guidances. 

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, 

Federal Register / Vol. 86, No. 178 / Friday, September 17, 2021 / Notices 51899 

1The active ingredients were previously 

identified as sucroferric oxyhydroxide and iron 

sucrose, respectively, at the time of approval of 

these NDAs. FDA later concluded that the active 

ingredient in both of these products is ferric 

oxyhydroxide. See Letter to Areta Kupchyk, Foley 

Hoag LLP, from Patrizia Cavazzoni, M.D., Acting 

Director, Center for Drug Evaluation and Research, 

Docket No. 2016–P–1163 (May 26, 2021). 

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 

Ferric Oxyhydroxide.’’ 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. 

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 

revised draft guidances on ferric 

oxyhydroxide oral tablets and ferric 

oxyhydroxide intravenous injectable. 

FDA initially approved new drug 

application (NDA) 205109 VELPHORO 

in November 2013 and NDA 021135 

VENOFER in November 2000.1 In March 

2015, FDA issued a draft product 

specific guidance for industry on 

generic ferric oxyhydroxide oral tablets 

(previously entitled ‘‘Draft Guidance for 

Sucroferric Oxyhydroxide’’) and in 

November 2013, FDA issued a draft 

product specific guidance for industry 

on generic ferric oxyhydroxide 

intravenous injectable (previously 

entitled ‘‘Draft Guidance for Iron 

Sucrose’’). We are now issuing revised 

draft guidances for industry on generic 

ferric oxyhydroxide oral tablets and 

ferric oxyhydroxide intravenous 

injectable. 

In August 2021, Sidley Austin LLP 

submitted a citizen petition requesting 

that FDA take several actions, including 

refraining from changing the product 

label or labeling for VENOFER, any 

action to modify the existing productspecific guidance for VENOFER, and 

any action to change the established 

name of VENOFER to ferric 

oxyhydroxide (Docket No. FDA–2021– 

P–0893). FDA is reviewing the issues 

raised in the petition and will consider 

any comments on the draft guidances 

entitled ‘‘Draft Guidance for Ferric 

Oxyhydroxide’’ before responding to the 

petition. FDA’s issuance of the draft 

guidances on generic ferric 

oxyhydroxide oral tablets and ferric 

oxyhydroxide intravenous injectable 

does not represent a final decision on 

the issues raised in the petition. 

The revised draft guidances are being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The revised draft guidances, 

when finalized, will represent the 

current thinking of FDA on the design 

of BE studies to support ANDAs for 

ferric oxyhydroxide. They do not 

establish any rights for any person and 

are 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. 

51900 Federal Register / Vol. 86, No. 178 / Friday, September 17, 2021 / Notices 

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: September 13, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–20064 Filed 9–16–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1967] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Biosimilars User 

Fee Program 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection associated with the Agency’s 

Biosimilars User Fee Program. 

DATES: Submit either electronic or 

written comments on the collection of 

information by November 16, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before November 16, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of November 16, 2021. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

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– 

2018–N–1967 for ‘‘Biosimilars User Fee 

Program.’’ Received comments, those 

filed in a timely manner (see 

ADDRESSES), 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. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice