Federal Register / Vol. 86, No. 150 / Monday, August 9, 2021 / Notices 43555 

with other statutory and regulatory 

provisions that pertain to devices. 

Therefore, stakeholders are invited to 

submit comments on timelines 

necessary for this transition and how 

FDA can facilitate this transition in a 

way that does not disrupt the supply of 

these important medical products or 

place undue burden on manufacturers 

or on the healthcare delivery system. 

4. User Fee Transitions 

CDER assesses user fees for certain 

new drug applications (NDAs) and 

products approved under those NDAs 

under the Prescription Drug User Fee 

Amendments (PDUFA). CDER also 

assesses user fees for certain abbreviated 

new drug applications (ANDAs) and 

products approved under those ANDAs 

under the Generic Drug User Fee 

Amendments (GDUFA). The PDUFA 

and GDUFA user fee programs both 

include specific fees assessed annually 

for certain marketed approved products. 

In the case of PDUFA, with certain 

exceptions or exemptions, annual 

prescription drug program fees are 

assessed for each strength of a 

prescription drug identified in an 

approved NDA, as of October 1 of each 

fiscal year (FY), provided the product is 

included in the ‘‘Prescription Drug 

Product List’’ (the ‘‘active section’’) of 

Approved Drug Products with 

Therapeutic Equivalence Evaluations 

(commonly known as the ‘‘Orange 

Book’’). 

In the case of GDUFA, annual GDUFA 

program fees are assessed with respect 

to approved ANDAs, and fee amounts 

are tiered based on the number of 

approved ANDAs owned by an entity 

(including its affiliates) as of October 1 

of each fiscal year. GDUFA also 

includes an annual facility fee for each 

facility referenced in an approved 

ANDA as a producer of an active 

pharmaceutical ingredient or finished 

dosage form covered by the ANDA. 

FDA does not anticipate that the 

identification and transitioning of 

products from drug status to device 

status pursuant to the Genus decision 

will be completed before October 1, 

2021. Persons assessed an annual fee 

with respect to a product identified in 

an approved NDA or ANDA as of that 

date should pay the assessed FY 2022 

fees by the due date to avoid being 

placed on the arrears list and incurring 

other penalties associated with failure to 

pay user fees by the due date. Payors of 

the annual FY 2022 fee with respect to 

a product that the payor believes should 

transition to device status under Genus 

are encouraged to request refunds of 

user fees attributable to those products. 

FDA anticipates that, for approved 

products that transition from drug status 

to device status under the process 

described above, refund requests for 

PDUFA and GDUFA fees that are 

received on time under section 736(i) or 

744B(m) of the FD&C Act (21 U.S.C. 

379h(i) or 379j–42(m)), respectively, 

will be granted. This would include 

requests for refund of the FY 2022 

prescription drug program fees assessed 

under PDUFA, or FY 2022 generic drug 

applicant program fees assessed under 

GDUFA that may result in a lower fee 

tier for an ANDA holder, as well as any 

GDUFA facility fees for a facility 

referenced in one or more ANDAs that 

will transition, if that facility is not also 

reported in other ANDAs that will not 

transition. Under PDUFA, to qualify for 

consideration for a refund, a written 

request must be submitted to FDA not 

later than 180 calendar days after the fee 

is due (see section 736(i) of the FD&C 

Act). Under GDUFA, to qualify for a 

return of a fee, a written request 

justifying the return must be submitted 

within 180 calendar days from the date 

of the fee payment (see section 744B(m) 

of the FD&C Act). 

More information about PDUFA and 

GDUFA fees and the submission of 

refund requests is available on FDA’s 

website at https://www.fda.gov/ 

industry/fda-user-fee-programs/ 

prescription-drug-user-fee-amendments 

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

industry/fda-user-fee-programs/genericdrug-user-fee-amendments (GDUFA). 

5. Determining Drug or Device Status 

FDA intends to establish a process for 

the orderly and efficient determination 

of which products currently regulated as 

drugs must be regulated as devices 

under Genus. We encourage sponsors of 

potentially affected products to 

comment on this notice, await the 

publication of our future notice 

identifying products that we have 

tentatively determined should transition 

to device status, and, in the meantime, 

reach out to FDA with time-sensitive 

questions. 

FDA has established the following 

contact point for all questions 

concerning the Genus decision and 

transition activities: Drug_Device_

Transition_Inquiry@fda.hhs.gov. 

Dated: August 2, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16944 Filed 8–6–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–0868] 

Development and Submission of Near 

Infrared Analytical Procedures; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled 

‘‘Development and Submission of Near 

Infrared Analytical Procedures.’’ This 

guidance provides recommendations to 

applicants to aid the development, 

validation, and use of near infrared 

(NIR)-based analytical procedures in 

evaluating the identity, strength, 

quality, purity, and potency of drug 

substances and drug products. The 

recommendations apply to new drug 

applications (NDAs), abbreviated new 

drug applications (ANDAs), and 

supplemental NDAs and ANDAs for 

small molecule drugs. The principles in 

this guidance also apply to drug 

substances and drug products covered 

in Type II drug master files. This 

guidance finalizes the draft guidance of 

the same title issued on March 31, 2015. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on August 9, 2021. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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. 


lotter on DSK11XQN23PROD with NOTICES1
43556 Federal Register / Vol. 86, No. 150 / Monday, August 9, 2021 / Notices 

• 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– 

2015–D–0868 for ‘‘Development and 

Submission of Near Infrared Analytical 

Procedures.’’ 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 this 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 guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Eugenia Nashed, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 4154, 

Silver Spring, MD 20993–0002, 301– 

796–1723. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Development and Submission of Near 

Infrared Analytical Procedures.’’ This 

guidance provides recommendations to 

applicants to aid the development, 

validation, and use of NIR-based 

analytical procedures in evaluating the 

identity, strength, quality, purity, and 

potency of drug substances and drug 

products. The recommendations apply 

to NDAs, ANDAs, and supplemental 

NDAs and ANDAs for small molecule 

drugs. The principles in this guidance 

also apply to drug substances and drug 

products covered in Type II drug master 

files. FDA intends to issue 

recommendations specific to NIR 

methods used for biological products 

under biologics license applications in a 

future revision to this guidance. 

Specifically, this guidance, among other 

things, (1) addresses the development 

and submission of NIR analytical 

procedures used during and for the 

manufacture and analysis of 

pharmaceuticals (including raw 

materials, in-process materials and 

intermediates, drug substances, and 

finished products); (2) provides 

recommendations to manufacturers for 

applying the concepts described in the 

guidance for industry entitled ‘‘PAT—A 

Framework for Innovative 

Pharmaceutical Development, 

Manufacturing, and Quality Assurance’’ 

(https://www.fda.gov/media/71012/ 

download) and the International 

Council for Harmonisation guidance for 

industry entitled ‘‘Q2(R1) Validation of 

Analytical Procedures: Text and 

Methodology’’ (https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/q2-r1-validationanalytical-procedures-text-andmethodology) to NIR analytical 

procedures that use chemometric 

models; and (3) describes the type of 

information that should be submitted 

about NIR analytical procedures in 

applications. 

This guidance pertains only to the 

development and validation of NIR 

analytical procedures and does not 

provide recommendations concerning 

the setup, qualification, maintenance, or 

calibration of NIR instruments. 

Although this guidance specifically 

addresses NIR spectroscopy, this 

guidance’s concepts of validation can be 

applied to other multivariate analytical 

technics, including, for example, 

Raman. 

This guidance finalizes the draft 

guidance entitled ‘‘Development and 

Submission of Near Infrared Analytical 

Procedures’’ issued on March 31, 2015 

(80 FR 17057). FDA considered 

comments received on the draft 

guidance as the guidance was finalized. 

Changes from the draft to the final 

guidance include updates to reflect 

Agency regulatory experience and 

technological advancements in the 

industry, as well as management of NIR 

procedures over the life cycle of the 

products. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on the development 

and submission of NIR analytical 

procedures. 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 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 150 / Monday, August 9, 2021 / Notices 43557 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR part 314 for 

NDAs and in 21 CFR parts 314 and 601 

for annual reports, ANDAs, and 

supplements to applications have been 

approved under OMB control numbers 

0910–0001 and 0910–0338, respectively. 

The collections of information in 21 

CFR part 211 for current good 

manufacturing practices for finished 

pharmaceuticals and medical gases have 

been approved under OMB control 

number 0910–0139. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

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

guidances-drugs or https://

www.regulations.gov. 

Dated: August 2, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16930 Filed 8–6–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; PAR19–319: NIDDK 

Central Repositories Non-Renewable Sample 

Access (X01) Review. 

Date: September 13, 2021. 

Time: 2:00 p.m. to 3:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Najma S. Begum, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 7349, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, (301) 594–8894, 

begumn@niddk.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: August 4, 2021. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–16901 Filed 8–6–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Aging Special Emphasis Panel; T32/T35 

Review January 2022 Council. 

Date: October 20, 2021. 

Time: 9:30 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, 7201 Wisconsin Avenue, 

Bethesda, MD 20892 (Video Meeting). 

Contact Person: Anita H. Undale, MD, 

Ph.D., Scientific Review Officer, Scientific 

Review Branch, National Institute on Aging, 

National Institutes of Health, Gateway 

Building, Suite 2W200, 7201 Wisconsin 

Avenue, Bethesda, MD 20892, 301–827– 

7428, anita.undale@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: August 4, 2021. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–16951 Filed 8–6–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; 

Amended Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the National Diabetes and 

Digestive and Kidney Diseases Advisory 

Council, September 09, 2021, 10:00 a.m. 

to September 10, 2021, 12:45 p.m., 

National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 which 

was published in the Federal Register 

on June 02, 2021, FR Doc 2021–11516, 

86 FR 29592. 

The meeting notice is amended to 

change the meeting time from 

September 9–10, 2021, 10:00 a.m. to 

1:45 p.m. To September 9–10, 2021, 

10:00 a.m. to 12:45 p.m. The meeting is 

partially Closed to the public. 

Dated: August 4, 2021. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–16952 Filed 8–6–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 


lotter on DSK11XQN23PROD with NOTICES1