Federal Register / Vol. 79, No. 223 / Wednesday, November 19, 2014 / Notices 68891 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Charu Mullick, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 6365, 

Silver Spring, MD 20993–0002, 301– 

796–1500. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Vaginal Microbicides: Development for 

the Prevention of HIV Infection.’’ This 

guidance addresses nonclinical 

development, early phases of clinical 

development, phase 3 trial 

considerations, and safety 

considerations in vaginal microbicide 

development including safety 

considerations in adolescent and 

pregnant populations. The guidance 

also outlines development of 

combination microbicide products such 

as drug-drug combinations, drug-device 

combinations, or combination products 

that include microbicide and are 

intended for multiple indications. This 

guidance finalizes the draft guidance 

issued on November 23, 2012 (77 FR 

70167). The majority of public 

comments submitted to the docket were 

related to clinical trial considerations 

and nonclinical pharmacology/

toxicology issues. This guidance 

incorporates FDA responses to the 

public comments. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on developing vaginal 

microbicides for preventing HIV 

transmission. It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information that 

are subject to review by the Office of 

Management and Budget under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). The collections of 

information in 21 CFR part 312 have 

been approved under 0910–0014, and 

the collections of information referred to 

in the guidance for clinical trial 

sponsors entitled ‘‘Establishment and 

Operation of Clinical Trial Data 

Monitoring Committees’’ have been 

approved under 0910–0581. 

II. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

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

ComplianceRegulatoryInformation/

Guidances/default.htm or http://

www.regulations.gov. 

Dated: November 13, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–27287 Filed 11–18–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1741] 

Proposed Criteria for ‘‘First Generic’’ 

Submissions for Purposes of 

Abbreviated New Drug Application 

Review Prioritization Under the 

Generic Drug User Fee Amendments; 

Establishment of a Public Docket 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of public 

docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the opening of a public 

docket and requesting comments on 

proposed criteria for ‘‘first generic’’ 

abbreviated new drug application 

(ANDA) submissions. The purpose is to 

facilitate FDA’s establishment of review 

prioritization under the Generic Drug 

User Fee Amendments of 2012 

(GDUFA). Establishing clear criteria for 

this review prioritization category will 

allow FDA to appropriately prioritize 

ANDA submissions and track them in a 

manner consistent with the review 

prioritization commitments FDA made 

under GDUFA. Clear criteria for this 

category will also lead to less industry 

confusion and more consistent 

identification of ‘‘first generic’’ 

submissions. 

DATES: Submit either electronic or 

written comments by December 19, 

2014. 

ADDRESSES: You may submit comments 

by any of the following methods: 

Electronic Submissions 

Submit electronic comments as 

follows: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written comments as follows: 

• Mail/Hand delivery/Courier (for 

paper submissions): Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Instructions: All submissions must 

include the Docket No. found in 

brackets in the heading of this 

document. All comments received may 

be posted without change to http://

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

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 or 

go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Maryll Toufanian, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1682, 

Silver Spring, MD 20993–0002, 240– 

402–7944. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On July 9, 2012, GDUFA (Title III of 

the Food and Drug Administration 

Safety and Innovation Act (Pub. L. 112– 

144)) was signed into law by the 

President. GDUFA is designed to speed 

the delivery of safe and effective generic 

drugs to the public and to reduce costs 

to industry. GDUFA is based on an 

agreement negotiated by FDA and 

representatives of the generic drug 

industry to address a growing number of 

regulatory challenges. An attendant 

mstockstill on DSK4VPTVN1PROD with NOTICES

68892 Federal Register / Vol. 79, No. 223 / Wednesday, November 19, 2014 / Notices 

1http://www.fda.gov/downloads/ForIndustry/

UserFees/GenericDrugUserFees/UCM282505.pdf. 

2http://www.fda.gov/AboutFDA/CentersOffices/

OfficeofMedicalProductsandTobacco/CDER/

ManualofPoliciesProcedures/. 

3https://www.federalregister.gov/articles/2014/

08/19/2014-19632/generic-drug-user-feeamendments-of-2012-public-hearing-on-policydevelopment-request-for-comments#footnote-4. 

4FDA evaluates each submitted ANDA 

individually to determine whether the ANDA can 

be received. The receipt of an ANDA means that 

FDA made a threshold determination that the 

ANDA is sufficiently complete to permit a 

substantive review. 

commitment letter enumerates the 

performance efficiencies, metric goals, 

and procedures to which FDA agreed for 

the GDUFA program (Commitment 

Letter).1 In a portion of the Commitment 

Letter relevant to this notice, FDA 

agreed to: (1) Expedite review of ANDAs 

in the year 1 and year 2 cohorts (i.e., 

those ANDAs submitted in fiscal year 

(FY) 2013 and FY2014, respectively) 

that are submitted on the first day that 

any valid paragraph IV application for 

the drug in question is submitted (firstto-file ANDA); (2) strive to review and 

act on all first-to-file ANDAs within 30 

months of submission to avoid 

inadvertent forfeiture of 180-day 

exclusivity eligibility under section 

505(j)(5)(D)(i)(IV) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

355(j)(5)(D)(i)(IV)); and (3) expedite 

review of ‘‘first generic’’ ANDAs for 

which there are no blocking patents or 

exclusivities. 

To help meet the goals in the 

Commitment Letter, FDA will prioritize 

ANDA reviews in conformance with the 

recently issued Manual of Policies and 

Procedures (MAPP) 5240.3 Rev. I: 

Prioritization of the Review of Original 

ANDAs, Amendments, and 

Supplements; and MAPP 5200.4: 

Criteria and Procedures for Managing 

the Review of Original ANDAs, 

Amendments and Supplements.2 These 

MAPPs contemplate FDA prioritizing its 

ANDA reviews in a manner consistent 

with the provisions of the Commitment 

Letter, which identify certain types of 

submissions, including ‘‘first generic’’ 

ANDA submissions, as representing 

public health priorities that will receive 

expedited review. The MAPPs also 

expressly describe prioritization of the 

ANDA types described previously. 

Subsequent to enactment of GDUFA, 

FDA has received informal comments 

on the Commitment Letter from several 

stakeholders that conveyed different 

understandings of the criteria for the 

‘‘first generic’’ review prioritization 

category. For example, stakeholders 

have characterized a ‘‘first generic’’ as 

the first ANDA submitted, the first 

ANDA approved, the first ANDA 

marketed, all first-to-file ANDAs, and a 

company’s ‘‘top priority’’ ANDA. 

Without clear criteria for this category, 

there is the potential for confusion and 

inconsistent review prioritization. 

On September 17, 2014, FDA’s Office 

of Generic Drugs held a public hearing 

to solicit public comment on certain 

topics related to implementation of 

GDUFA.3 The hearing provided an 

opportunity for public input on future 

policy priorities. At that hearing, FDA 

solicited comment on the specific 

criteria FDA should apply to identify an 

ANDA as a ‘‘first generic’’ eligible for 

expedited review. FDA has considered 

comments provided at that hearing and 

submitted to the related public docket. 

Today, FDA is announcing proposed 

criteria for the review prioritization 

category of ‘‘first generic’’ ANDA 

submissions. 

II. Request for Comments and 

Supporting Information 

FDA is requesting comments and 

supporting information on the following 

criteria for a ‘‘first generic’’ ANDA for 

the purposes of review prioritization. A 

first generic application is any received 

ANDA 4: (1) That is a first-to-file ANDA 

eligible for 180-day exclusivity, or for 

which there are no blocking patents or 

exclusivities; and (2) for which there is 

no previously-approved ANDA for the 

drug product. 

FDA believes that these proposed 

criteria appropriately focus FDA’s 

resources on approving as quickly as 

possible, new safe and effective generic 

drug products for patient use. The 

Agency also believes that these criteria 

are consistent with the broad scope of 

the Commitment Letter, and generally 

reflect industry intent. Finally, these 

criteria enable FDA to prioritize review 

of a pending ANDA when the date on 

which the ANDA can be approved alters 

due to changes in the patent or 

exclusivity landscape. 

We note that under these proposed 

criteria, ‘‘first generic’’ status is 

predicated largely on circumstances 

outside Agency control, and ones that 

may change while the ANDA is 

pending, for example, developments 

related to the disposition of related 

patent litigation. Accordingly, FDA also 

is seeking comments and supporting 

information on mechanisms the Agency 

could put in place to facilitate ANDA 

sponsor submission of such relevant 

information in a timely manner, in 

addition to that already required under 

the regulations. 

We also note that as a result of such 

developments, ANDA submissions that 

originally met the criteria for a ‘‘first 

generic’’ submission may no longer 

meet those criteria; for example, the 

validity of a patent may be upheld in 

litigation, thereby blocking approval 

until patent expiry. 

We thus are seeking comment on 

whether FDA should change the review 

prioritization for an ANDA that no 

longer meets the ‘‘first generic’’ criteria 

during its review. 

III. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

Dated: November 13, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–27385 Filed 11–18–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: Detection of Infectious Prion 

Protein by Seeded Conversion of 

Recombinant Prion Protein 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: This is notice, in accordance 

with 35 U.S.C. 209 and 37 CFR Part 404, 

that the National Institutes of Health 

(NIH), Department of Health and Human 

Services, is contemplating the grant of 

an exclusive patent license to Amprion, 

Inc. located in Houston Texas, USA, to 

practice the inventions embodied in the 

following Patents and Patent 

Applications, each entitled ‘‘Detection 

of Infectious Prion Protein by Seeded 

Conversion of Recombinant Prion 

Protein’’: 

1. US provisional Application 60/

961,364 filed July 20, 2007 [HHS Ref. 

No. E–109–2007/0–US–01] 

2. PCT/US2008/070656, filed July 21, 

2008; [HHS Ref. No E–109–2007/1– 

PCT–01] 

3. EPC application No 08796382.3 

filed July 21, 2008 [HHS Ref. No E–109– 

2007/1–EP–03] 

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