Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 46075 

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 

New requests to be placed on the lists ................... 2,000 1 2,000 1 ................................ 2,000 

Biennial update ........................................................ 2,000 1 2,000 0.5 (30 minutes) ........ 1,000 

Occasional updates ................................................. 200 1 200 0.5 (30 minutes) ........ 100 

Total .................................................................. ........................ ........................ ........................ .................................... 3,100 

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

FDA bases its estimate on the number 

of manufacturers/processors that have 

submitted new written requests, 

biennial updates, and occasional 

updates over the past 10 years. The 

estimate of the number of burden hours 

it will take a manufacturer/processor to 

gather the information needed to be 

placed on the list or update its 

information is based on FDA’s 

experience with manufacturers/ 

processors submitting similar requests. 

FDA believes that the information to be 

submitted will be readily available to 

manufacturers/processors. This 

collection is also incorporating 

information collected to maintain lists 

of eligible exporters of dairy products 

who wish to export to the EU from OMB 

control number 0910–0320, ‘‘Request for 

Information from U.S. Processors that 

Export to the European Community.’’ 

FDA estimates that 2,000 firms will 

average 60 minutes (1 hour) to submit 

new requests for inclusion on the list, 

2,000 firms will average 30 minutes (0.5 

hour) to update their information every 

2 years, and 200 firms will average 30 

minutes (0.5 hour) to occasionally 

update their information in this system. 

We also believe that submission via the 

electronic registry system will not affect 

the burden estimates. An electronic 

registry will enhance the ability of firms 

to more efficiently request inclusion on 

export lists. FDA calculates, therefore, 

that the total burden for this collection 

is 3,100 hours ((2,000 × 1) plus (2,000 

× 0.5) plus (200 × 0.5)). 

Dated: September 28, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21212 Filed 10–2–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5767] 

Abbreviated New Drug Applications for 

Certain Highly Purified Synthetic 

Peptide Drug Products That Refer to 

Listed Drugs of Recombinant 

Deoxyribonucleic Acid Origin; 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 ‘‘ANDAs 

for Certain Highly Purified Synthetic 

Peptide Drug Products That Refer to 

Listed Drugs of rDNA Origin.’’ The 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) permits any person to 

submit to the FDA an abbreviated new 

drug application (ANDA) to seek 

approval to market a generic version of 

a previously approved drug product. 

This draft guidance is intended to assist 

potential applicants in determining 

when an application for a synthetic 

peptide drug product (specifically 

glucagon, liraglutide, nesiritide, 

teriparatide, and teduglutide) that refers 

to a previously approved peptide drug 

product of recombinant 

deoxyribonucleic acid (rDNA) origin 

should be submitted as an ANDA rather 

than as new drug application (NDA). 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 4, 2017 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– 

2017–D–5767 for ‘‘ANDAs for Certain 

Highly Purified Synthetic Peptide Drug 

Products That Refer to Listed Drugs of 

rDNA Origin.’’ 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. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
46076 Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 

• 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 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.gpo.gov/ 

fdsys/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. 

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: Gail 

Schmerfeld, Office of Generic Drugs, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1672, Silver Spring, MD 

20993–0002, 301–796–9291. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘ANDAs for Certain Highly Purified 

Synthetic Peptide Drug Products That 

Refer to Listed Drugs of rDNA Origin.’’ 

In general, for FDA to approve an ANDA 

submitted under section 505(j) of the 

FD&C Act, an ANDA applicant must 

demonstrate, among other things, that 

the proposed generic drug has the 

‘‘same’’ active ingredient(s) as and is 

bioequivalent to its reference listed 

drug, and that the methods used in, and 

the facilities and controls used for, the 

manufacture, processing, and packing of 

the proposed generic drug are adequate 

to assure and preserve its identity, 

strength, quality, and purity (sections 

505(j)(2)(A) and (4) (21 U.S.C. 

355(j)(2)(A) and (4)) of the FD&C Act). 

If a person is seeking approval of a 

synthetic peptide drug product 

(specifically glucagon, liraglutide, 

nesiritide, teriparatide, or teduglutide) 

and intends to submit an application 

that refers to a previously approved 

peptide drug product of rDNA origin, if 

the active ingredient in the proposed 

synthetic peptide drug product can be 

shown to be the same as the active 

ingredient in the peptide drug product 

of rDNA origin, whether the application 

should be submitted as an ANDA under 

section 505(j) of the FD&C Act or as a 

new drug application under section 

505(b) of the FD&C Act will depend 

largely on the impurity profile for the 

synthetic peptide drug product as 

compared to the impurity profile for the 

peptide drug product of rDNA origin. 

Differences in impurities, particularly 

peptide-related impurities, may affect 

the safety or effectiveness of a peptide 

drug product. This draft guidance is 

intended to assist potential applicants 

in determining when an application for 

a synthetic peptide drug product that 

refers to a previously approved peptide 

drug product of rDNA origin should be 

submitted as an ANDA rather than an 

NDA. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on the submission of ANDAs for certain 

highly purified synthetic peptide drug 

products that refer to listed drugs of 

rDNA origin. 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. This draft guidance is 

not subject to Executive Order 12866. 

II. The Paperwork Reduction Act of 

1995 

This draft guidance refers to 

previously approved collections of 

information that are subject to review by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). The 

collection of information required under 

21 CFR part 314 for the submission of 

NDAs and ANDAs is approved under 

OMB control number 0910–0001, and 

the submission of controlled 

correspondence pertaining to ANDAs is 

approved under OMB control number 

0910–0797. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or https://www.

regulations.gov. 

Dated: September 28, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21202 Filed 10–2–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4918] 

Joint Meeting of the 

Psychopharmacologic Drugs 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 or Agency) 

announces a forthcoming public 

advisory committee meeting of the 

Psychopharmacologic Drugs Advisory 

Committee and the Drug Safety and Risk 

Management Advisory Committee. The 

general function of the committee is to 

provide advice and recommendations to 

the Agency on FDA’s regulatory issues. 

The meeting will be open to the public. 

FDA is establishing a docket for public 

comment on this document. 


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