Federal Register / Vol. 80, No. 25 / Friday, February 6, 2015 / Notices 6729 

TABLE 1—CERTIFICATES AND USES

Type of certificate Use 

‘‘Supplementary Information Certificate to Foreign Government Requests’’. 

‘‘Exporter’s Certification Statement Certificate to Foreign Government’’. 

‘‘Exporter’s Certification Statement Certificate to Foreign Government 

(For Human Tissue Intended for Transplantation)’’. 

For the export of products legally marketed in the United States. 

‘‘Supplementary Information Certificate of Exportability Requests’’. 

Exporter’s Certification Statement Certificate of Exportability’’. 

For the export of products not approved for marketing in the United 

States (unapproved products) that meet the requirements of sections 

801(e) or 802 of the FD&C Act. 

‘‘Supplementary Information Certificate of a Pharmaceutical Product’’. 

‘‘Exporter’s Certification Statement Certificate of a Pharmaceutical 

Product’’. 

Conforms to the format established by the World Health Organization 

and is intended for use by the importing country when the product in 

question is under consideration for a product license that will authorize its importation and sale or for renewal, extension, amending, or 

reviewing a license. 

‘‘Supplementary Information Non-Clinical Research Use Only Certificate’’.

‘‘Exporter’s Certification Statement (Non-Clinical Research Use Only)’’. 

For the export of a non-clinical research use only product, material, or 

component that is not intended for human use which may be marketed in, and legally exported from the United States under the 

FD&C Act. 

FDA will continue to rely on selfcertification by manufacturers for the 

first three types of certificates listed in 

table 1 of this document. Manufacturers 

are requested to self-certify that they are 

in compliance with all applicable 

requirements of the FD&C Act, not only 

at the time that they submit their 

request to the appropriate center, but 

also at the time that they submit the 

certification to the foreign government. 

The appropriate FDA centers will 

review product information submitted 

by firms in support of their certificate 

and any suspected case of fraud will be 

referred to FDA’s Office of Criminal 

Investigations for follow up. Making or 

submitting to FDA false statements on 

any documents may constitute 

violations of 18 U.S.C. 1001, with 

penalties including up to $250,000 in 

fines and up to 5 years imprisonment. 

In the Federal Register of November 

14, 2014 (79 FR 68277), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA center and FDA form Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Center for Biologics Evaluation and Research .................... 2,114 1 2,114 1 2,114 

FDA 3613.

FDA 3613a.

FDA 3613b.

FDA 3613c.

Center for Devices and Radiological Health ....................... 10,528 1 10,528 2 21,056 

FDA 3613.

FDA 3613a.

FDA 3613c.

Center for Veterinary Medicine ............................................ 855 1 855 1 855 

FDA 3613.

FDA 3613a.

FDA 3613b.

Total .............................................................................. ........................ ........................ ........................ ........................ 24,025 

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

Dated: January 30, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–02348 Filed 2–5–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1168] 

Generic Drug User Fee Amendments of 

2012; September 2014 Public Hearing 

on Policy Development; Reopening of 

Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; reopening of docket; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

reopening of the docket to solicit public 

comment on certain topics related to 

implementation of the Generic Drug 

User Fee Amendments of 2012 (GDUFA) 

and the GDUFA Commitment Letter that 

accompanies the legislation. A public 

hearing in September 2014 provided an 

opportunity for public input on future 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
6730 Federal Register / Vol. 80, No. 25 / Friday, February 6, 2015 / Notices 

1See Generic Drug User Fee Act Program 

Performance Goals and Procedures (GDUFA 

Commitment Letter) for fiscal years 2013 through 

2017, available at http://www.fda.gov/downloads/

ForIndustry/UserFees/GenericDrugUserFees/

UCM282505.pdf). 

2The draft guidance documents referenced in this 

document are available on the FDA Drugs guidance 

Web page at http://www.fda.gov/Drugs/

GuidanceComplianceRegulatoryInformation/

Guidances/default.htm. 

policy priorities. FDA is seeking 

additional written comments from all 

interested parties, including, but not 

limited to, regulated industry, 

consumers, patients, caregivers, health 

care professionals, and patient groups. 

DATES: Submit electronic or written 

comments by March 9, 2015. 

ADDRESSES: Submit electronic 

comments to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Giaquinto, Office of Generic 

Drugs, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg 75, Rm. 1670, Silver Spring, 

MD 20993–0002, 240–402–7930, 

elizabeth.giaquinto@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Drug Price Competition and 

Patent Term Restoration Act of 1984 

(Pub. L. 98–417) (the Hatch-Waxman 

Amendments) amended the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act). The Hatch-Waxman 

Amendments created section 505(j) of 

the FD&C Act (21 U.S.C. 355(j)), which 

established the abbreviated new drug 

application (ANDA) approval pathway, 

which allows lower-priced generic 

versions of previously approved 

innovator drugs to be approved and 

marketed. 

On July 9, 2012, GDUFA was signed 

into law by the President to help speed 

the delivery of safe and effective generic 

drugs to the public and to reduce costs 

to industry. Under GDUFA, FDA agreed 

to certain obligations as laid out in the 

GDUFA Commitment Letter that 

accompanies the legislation.1 To 

support these obligations, FDA is 

developing numerous guidance 

documents. At the time of the 

September 2014 public hearing, FDA 

had developed the following draft 

guidances for industry: 2

• ‘‘ANDA Submissions—Content and 

Format of Abbreviated New Drug 

Applications’’ 

• ‘‘ANDA Submissions—Refuse to 

Receive for Lack of Proper 

Justification of Impurity Limits’’ 

• ‘‘ANDA Submissions—Amendments 

and Easily Correctable Deficiencies 

Under GDUFA’’ 

• ‘‘ANDA Submissions—Prior Approval 

Supplements Under GDUFA’’ 

• ‘‘Controlled Correspondence Related 

to Generic Drug Development’’ 

II. Purpose and Scope of the September 

2014 Public Hearing 

A. GDUFA Implementation: Draft 

Guidance Documents 

The purpose of the public hearing was 

to: (1) Solicit public comment on the 

five draft guidance documents described 

in section I that FDA had issued to 

facilitate implementation of GDUFA and 

(2) recommend future policy priorities, 

including recommendations for 

additional guidance topics to facilitate 

GDUFA implementation. We continue 

to solicit comments from interested 

members of the public, including 

industry, consumers, patient groups, 

caregivers, and health care 

professionals, on the following topics 

related to GDUFA implementation 

guidances: 

• Are there comments on the five 

guidances described in section I? 

• Are there GDUFA implementation 

issues related to the five draft guidances 

described in section I that have not been 

addressed? 

• What other GDUFA implementation 

topics need the development of 

guidance? 

• Are there any topics or issues 

related to generic drug development 

other than those related to GDUFA 

implementation that need the 

development of guidance? 

B. GDUFA Implementation Related to 

Generic Drug Exclusivity 

Another purpose of the hearing was to 

solicit feedback on issues that may arise 

in FDA’s consideration of 180-day 

exclusivity provided for in section 

505(j)(5)(B)(iv) of the FD&C Act. 

Timing of ANDA approval is directly 

affected by an applicant’s eligibility for 

180-day exclusivity, and thus FDA’s 

consideration of any issues related to 

180-day exclusivity is a component of 

approval actions. FDA decisions 

regarding 180-day exclusivity are factspecific, and the facts that have the 

potential to determine eligibility for 

exclusivity may shift up to the time 

when an ANDA that is eligible for 180- 

day exclusivity, or another ANDA 

referencing the same listed drug, is 

ready for approval. 

With the enactment of GDUFA, FDA 

will take actions on pending 

applications consistent with the 

timeframes agreed upon in the GDUFA 

Commitment Letter. During the hearing, 

we sought input on possible processes 

FDA might introduce under GDUFA for 

making determinations on 180-day 

exclusivity, as described in the 

following questions: 

• Should FDA’s consideration of 

eligibility for 180-day exclusivity for a 

specific drug product be a public 

process, including consideration of 

whether a first applicant has forfeited its 

eligibility for exclusivity under section 

505(j)(5)(D) of the FD&C Act? If a public 

process is advisable, would it be so in 

all instances, or is there a subset of 

circumstances in which the process 

should be public? Also, what 

administrative mechanisms would best 

facilitate such a process? 

• Legal challenges to FDA’s decisions 

on 180-day exclusivity often must be 

resolved on an expedited basis that can 

be inconvenient for the parties and the 

court. What legal or regulatory 

mechanisms, if any, are available to 

better facilitate FDA’s determination of 

and orderly resolution of sponsors’ 

challenges to 180-day exclusivity 

determinations? 

• Are there other topics related to 

180-day exclusivity on which you 

would like to comment? 

• Are there topics related to 180-day 

exclusivity that would benefit from FDA 

guidance? 

We continue to seek comment on 

these topics. When submitting input on 

the questions provided in this notice, 

we encourage commenters to consider 

FDA’s statutory and regulatory 

authorities, including any restrictions 

on FDA’s authority to disclose certain 

information related to unapproved 

ANDAs. 

C. GDUFA Implementation and 

Potential First Generics 

At the public hearing, we also sought 

comment on meeting the goals of the 

GDUFA Commitment Letter with regard 

to the ‘‘first generics’’ review 

prioritization category. Subsequent to 

that hearing, the Agency opened a 

separate, dedicated docket, Docket No. 

FDA–2014–N–1741, seeking comment 

on ‘‘first generic’’ criteria, as described 

in the Federal Register notice 

‘‘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.’’ This 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 25 / Friday, February 6, 2015 / Notices 6731 

docket opened on November 19, 2014, 

and closed on December 19, 2014. We 

are no longer seeking comment on the 

‘‘first generic’’ review prioritization 

category at this time. 

III. How To Submit 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: February 2, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–02401 Filed 2–5–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0824] 

Anesthetic and Analgesic Drug 

Products Advisory Committee; Notice 

of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Anesthetic and 

Analgesic Drug Products Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on March 18, 2015, from 8 a.m. to 

5 p.m. 

Location: Holiday Inn Gaithersburg, 

Grand Ballroom, 2 Montgomery Village 

Ave., Gaithersburg, MD 20879. The 

hotel’s telephone number is 301–948– 

8900. Answers to commonly asked 

questions including information 

regarding special accommodations due 

to a disability, visitor parking, and 

transportation may be accessed at: 

http://www.fda.gov/

AdvisoryCommittees/

AboutAdvisoryCommittees/

ucm408555.htm. 

Contact Person: Stephanie L. 

Begansky, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, Rm. 2417, Silver Spring, 

MD 20993–0002, 301–796–9001, FAX: 

301–847–8533, email: AADPAC@

fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site at http://

www.fda.gov/AdvisoryCommittees/

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: The committee will discuss 

new drug application (NDA) 022225, 

sugammadex sodium injection, 

submitted by Organon USA Inc., for the 

proposed indication of reversal of 

moderate or deep neuromuscular 

blockade induced by rocuronium or 

vecuronium. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/

AdvisoryCommittees/Calendar/

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before March 4, 2015. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before February 

24, 2015. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by February 25, 2015. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Stephanie L. 

Begansky at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/

AdvisoryCommittees/

AboutAdvisoryCommittees/

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: February 2, 2015. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2015–02408 Filed 2–5–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0179] 

Training Program for Regulatory 

Project Managers; Information 

Available to Industry 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA’s) Center for 

Drug Evaluation and Research (CDER) is 

announcing the continuation of the 

Regulatory Project Management Site 

Tours and Regulatory Interaction 

Program (the Site Tours Program). The 

purpose of this document is to invite 

pharmaceutical companies interested in 

participating in this program to contact 

CDER. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES