9510 Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2030] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Application for 

Food and Drug Administration 

Approval To Market a New Drug 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by March 18, 

2021. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0001. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

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: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Application for FDA Approval To 

Market a New Drug; OMB Control No. 

0910–0001—Revision 

This information collection supports 

FDA regulations. Under section 505(a) 

of the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (21 U.S.C. 355(a)), a 

new drug may not be commercially 

marketed in the United States unless an 

approval of an application filed with 

FDA under section 505(b) or (j) of the 

FD&C Act is effective with respect to 

such drug. We have issued regulations 

in part 314 (21 CFR part 314) to govern 

procedures and requirements for 

applications submitted in accordance 

with section 505. The regulations in 

subpart A (§§ 314.1 through 314.3) set 

forth general provisions, while 

regulations in subparts B and C 

(§§ 314.50 through 314.99) set forth 

content and format requirements for 

new drug applications (NDAs) and 

abbreviated new drug applications 

(ANDAs) respectively. The regulations 

include requirements for the submission 

of specific data elements along with 

patent information, pediatric use 

information, supplements and 

amendments, proposed labeling, and 

specific postmarketing reports. 

Respondents to the information 

collection are sponsors of these 

applications. 

To assist respondents to the 

information collection we have 

developed the following forms: 

• Form FDA 0356h (and instructions): 

Application to Market a New or 

Abbreviated New Drug or Biologic for 

Human Use; 

• Form FDA 2252 (and instructions): 

Transmittal of Annual Reports for Drugs 

and Biologics For Human Use 

(§ 314.81); 

• Form FDA 2253 (and instructions): 

Transmittal of Advertisements and 

Promotional Labeling For Drugs and 

Biologics For Human Use; and 

• Forms FDA 3331/3331a: Field Alert 

Report and Instruction 

• Forms FDA 3542 and 3542a and 

Instructions: Patent Information 

Submitted Upon and After Approval of 

an NDA Supplement; Patent 

Information Submitted With the Filing 

of an NDA, Amendment, or Supplement 

• New Draft Form FDA 3898 and 

Instruction: Drug Master File 

Individuals requesting printed forms 

are instructed to contact the FDA Forms 

Manager by email at formsmanager@

OC.FDA.GOV. Certain fees may be 

applicable. 

Regulations in subpart D (§§ 314.100 

through 314.170) explain Agency 

actions on applications and set forth 

timeframes for FDA review. We are 

revising the information collection to 

include provisions established through 

our Agency user fee programs, most 

recently authorized under the FDA 

Reauthorization Act of 2017. These 

provisions pertain to review 

transparency, communications with 

FDA, dispute resolution, drug safety 

enhancements, and the allocation of 

Agency resources to align with these 

program objectives as agreed to with our 

stakeholders and set forth in our 

‘‘Performance Goals for Fiscal Years 

2018–2022’’ Commitment Letters, which 

are available from our website at https:// 

www.fda.gov along with more 

information about FDA user fee 

programs. 

Information collection pertaining to 

hearing and other administrative 

proceedings covered in 21 CFR subpart 

E are approved under OMB control no. 

0910–0191. Unless otherwise noted, 

information collection pertaining to 

postmarket safety reporting and 

associated recordkeeping is approved 

under OMB control nos. 0910–0230, 

0910–0291, and 0910–0645. 

Included among the miscellaneous 

provisions in subpart G (§§ 314.410 to 

314.445), § 314.420 covers information 

to include in drug master files (DMFs). 

To assist respondents to this 

information collection we have 

prepared templates and resources 

available from our website at 

www.fda.gov/drugs/forms-submissionrequirements/drug-master-files-dmfs. As 

noted above, we have developed new 

Form FDA 3898 and accompanying 

instructions on submitting DMFs in 

accordance with the applicable 

regulations. In accordance with 

§ 314.445, we also develop Agency 

guidance documents to assist 

respondents in complying with 

provisions in part 314. These guidance 

documents are issued consistent with 

our good guidance practice regulations 

at § 10.115. To search available FDA 

guidance documents, visit our website 

at https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. Finally, applications 

submitted in accordance with subpart H 

(§§ 314.500 through 314.560) pertain to 

accelerated approval of new drugs for 

serious or life-threatening illness, and 

submissions in subpart I (§§ 314.600 

through 314.650) pertain to approval of 

new drugs when human efficacy studies 

are not ethical or feasible. The 

regulations provide for the submission 

of specific data elements along with 

promotional material. 

We use the information collection to 

approve drugs shown to be safe and 

effective and to implement effective 

public health monitoring systems. We 

also use product approval and related 

patent and exclusivity information to 

publish the ‘‘Approved Drug Products 

with Therapeutic Equivalence 

Evaluations’’ list (the Orange Book). 

More information regarding the Orange 

Book is available from our website at 

https://www.fda.gov/drugs/drugapprovals-and-databases/approveddrug-products-therapeutic-equivalenceevaluations-orange-book. 

In the Federal Register of November 

16, 2020 (85 FR 73057), we published a 

60-day notice requesting public 


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Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices 9511 

comment on the proposed collection of 

information. No comments were 

received and we have therefore made no 

adjustments to our estimate, which is as 

follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden 

per response 

(in hours) 

Total hours 

Subpart B 

314.50(a)–(l)—Content and format of a 505(b)(1) or 

505(b)(2) application ........................................................ 121 1.15 139 1,921 267,019 

314.50(i)(1)—patent certifications: 

Form FDA 3542 ............................................................ 281 2.875 808 10 8,080 

Form FDA 3542a .......................................................... 310 2.084 646 15 9,690 

314.50(i)(6) amended patent certifications .......................... 17 1 17 2 34 

314.52(a), (b), and (e)—NDAs—notice of noninfringement 

of patent certification ........................................................ 15 3 45 15 675 

314.52(c)—Noninfringement of patent certification notice 

content .............................................................................. 22 3 66 0.33 (20 

minutes) 

22 

314.53(f)(1)—Correction of patent information errors by 

persons other than the NDA holder ................................. 24 1 24 10 240 

314.53(f)(2)—Correction of patent information errors by 

the NDA holder ................................................................. 28 1.4 39 1 39 

314.60—Amendments to unapproved NDA, supplement or 

resubmission .................................................................... 256 8.23 2,106 80 168,480 

314.60(f)—patent certifications for unapproved applications .................................................................................. 6 1 6 2 12 

314.65—Withdrawal of unapproved applications ................ 14 1.21 17 2 34 

314.70 and 314.71—Supplements and other changes to 

approved application ........................................................ 492 6.57 3,232 150 484,800 

314.72—Changes of ownership of NDAs ............................ 67 1.45 97 2 194 

314.81—Other postmarketing reports 314.81(b)(1) [3331 

and 3331a field alert reports and followups] .................... 484 20.3 9,834 8 78,672 

314.81(b)(2)[2252]—Annual reports .................................... 626 4.9 3,066 40 122,640 

314.81(b)(2)[2253]—Promotional labeling ........................... 331 141.3 46,782 2 93,564 

Subpart C 

314.94(a)and(d)—ANDA content ......................................... 229 4.3 987 480 473,760 

314.94(a)(12)(viii) amended patent certifications before approval of ANDA ................................................................ 153 1 153 2 306 

314.95(c)—Non-infringement of patents (ANDAs) .............. 400 3 1,200 0.33 (20 

minutes) 

400 

314.96(a)(1)—Amendments to unapproved ANDAs ........... 451 36.2 16,311 80 1,304,880 

314.96(c) amendment for pharmaceutical equivalent to a 

listed drug other than RLD ............................................... 1 1 1 300 300 

314.96(d)—patent certification requirements ....................... 100 1 100 2 200 

314.97—Supplements and other changes to ANDAs ......... 361 22.8 8,237 80 658,960 

314.97(b) Supplements to ANDA for pharmaceutical 

equivalent to a listed drug other than RLD ...................... 1 1 1 300 300 

314.99(a)—ANDA Applicants: Withdrawal of unapproved 

ANDAs .............................................................................. 77 2.3 177 2 354 

314.99(a)—ANDA Transfer of ownership ............................ 135 1.24 167 2 334 

Subpart D 

314.101(a)—NDA or ANDA filing over protest .................... 1 1 1 0.5 (30 

minutes) 

0.5 

314.107(e)—notification of court actions or written consent 

to approval ........................................................................ 247 2 494 0.5 (30 

minutes) 

247 

Subparts G, H, and I 

314.420—drug master files [FDA 3938]—original amendments ................................................................................ 36 27.2 981 61 59,841 

DMFs—technical, administrative, REMS) ............................ 2,946 11.4 33,590 8 268,720 

DMFs—annual reports ......................................................... 2,946 3.33 9,834 4 39,336 

314.550—Promotional material and subpart H applications 55 11.6 640 120 76,800 

Total .............................................................................. ........................ ........................ ........................ ........................ 4,118,933.5 


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9512 Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices 

Our estimated burden for the 

information collection reflects a 

decrease. We attribute this adjustment 

to improved operational efficiencies 

with regard to Agency data systems and 

digital submission processes. 

Dated: February 8, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03023 Filed 2–12–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0134] 

Joint Meeting of the Arthritis Advisory 

Committee and the Drug Safety and 

Risk Management Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Arthritis Advisory 

Committee and the Drug Safety and Risk 

Management Advisory Committee. The 

general function of the committees is to 

provide advice and recommendations to 

FDA on regulatory issues. The meeting 

will be open to the public. FDA is 

establishing a docket for public 

comment on this document. 

DATES: The meeting will be held on 

March 24, 2021, from 9 a.m. to 4:30 p.m. 

Eastern Time and March 25, 2021, from 

10 a.m. to 1 p.m. Eastern Time. 

ADDRESSES: Please note that due to the 

impact of this COVID–19 pandemic, all 

meeting participants will be joining this 

advisory committee meeting via an 

online teleconferencing platform. 

Answers to commonly asked questions 

about FDA advisory committee meetings 

may be accessed at: https://

www.fda.gov/AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2021–N–0134. 

The docket will close on March 23, 

2021. Submit either electronic or 

written comments on this public 

meeting by March 23, 2021. Please note 

that late, untimely filed comments will 

not be considered. Electronic comments 

must be submitted on or before March 

23, 2021. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

March 23, 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. 

Comments received on or before 

March 10, 2021, will be provided to the 

committees. Comments received after 

that date will be taken into 

consideration by FDA. In the event that 

the meeting is cancelled, FDA will 

continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 

You may submit comments 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– 

2021–N–0134 for ‘‘Joint Meeting of the 

Arthritis Advisory Committee and the 

Drug Safety and Risk Management 

Advisory Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments.’’ 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.’’ FDA 

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 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 the 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: 

Moon Hee V. Choi, Center for Drug 


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