Federal Register / Vol. 79, No. 208 / Tuesday, October 28, 2014 / Notices 64201 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Total ............................... ....................................................................... ........................ ........................ ........................ 386 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2014–25562 Filed 10–27–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–P–0979] 

Determination That DIAMOX 

(Acetazolamide) Intravenous, 500 

Milligrams Base/Vial, and DIAMOX 

(Acetazolamide) Tablets, 125 

Milligrams and 250 Milligrams, Were 

Not Withdrawn From Sale for Reasons 

of Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that DIAMOX (acetazolamide) 

intravenous, 500 milligrams (mg) base/ 

vial, and DIAMOX (acetazolamide) 

tablets, 125 mg and 250 mg, were not 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination means that FDA will not 

begin procedures to withdraw approval 

of abbreviated new drug applications 

(ANDAs) that refer to these drug 

products, and it will allow FDA to 

continue to approve ANDAs that refer to 

these products, if all other legal and 

regulatory requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Ayako Sato, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6228, Silver Spring, 

MD 20993–0002, 240–402–4191. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products under an 

ANDA procedure. ANDA applicants 

must, with certain exceptions, show that 

the drug for which they are seeking 

approval contains the same active 

ingredient in the same strength and 

dosage form as the ‘‘listed drug,’’ which 

is a version of the drug that was 

previously approved. ANDA applicants 

do not have to repeat the extensive 

clinical testing otherwise necessary to 

gain approval of a new drug application 

(NDA). 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

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

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (§ 314.162 (21 

CFR 314.162)). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

DIAMOX (acetazolamide) 

intravenous, 500 mg base/vial, is the 

subject of NDA 009–388, held by Teva 

Branded Pharmaceutical Products R&D, 

Inc., and initially approved on June 25, 

1954. DIAMOX (acetazolamide) tablets, 

125 mg and 250 mg, are the subject of 

NDA 008–943, held by Teva Branded 

Pharmaceutical Products R&D, Inc., and 

initially approved on July 27, 1953. 

DIAMOX (acetazolamide) intravenous, 

500 mg base/vial, and DIAMOX 

(acetazolamide) tablets, 125 mg and 250 

mg, are indicated for adjunctive 

treatment of: Edema due to congestive 

heart failure; drug-induced edema; 

centrencephalic epilepsies (petit mal, 

unlocalized seizures); and chronic 

simple (open-angle) glaucoma, 

secondary glaucoma, and preoperatively 

in acute angle-closure glaucoma where 

delay of surgery is desired in order to 

lower intraocular pressure. DIAMOX 

(acetazolamide) intravenous, 500 mg 

base/vial, and DIAMOX (acetazolamide) 

tablets, 125 mg and 250 mg, are also 

indicated for the prevention or 

amelioration of symptoms associated 

with acute mountain sickness in 

climbers attempting rapid ascent and in 

those who are very susceptible to acute 

mountain sickness despite gradual 

ascent. 

DIAMOX (acetazolamide) 

intravenous, 500 mg base/vial, and 

DIAMOX (acetazolamide) tablets, 125 

mg and 250 mg, are currently listed in 

the ‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Emcure Pharmaceuticals USA, Inc., 

submitted a citizen petition dated July 

3, 2014 (Docket No. FDA–2014–P– 

0979), under 21 CFR 10.30, requesting 

that the Agency determine that 

DIAMOX (acetazolamide) intravenous, 

500 mg base/vial, was discontinued for 

reasons unrelated to safety and 

effectiveness. Although the citizen 

petition did not address DIAMOX 

(acetazolamide) tablets, 125 mg and 250 

mg, since those products have also been 

discontinued, on our own initiative, we 

therefore determined whether DIAMOX 

(acetazolamide) tablets, 125 mg and 250 

mg, were withdrawn for safety or 

effectiveness reasons. 

After considering the citizen petition 

and reviewing Agency records, FDA has 

determined under § 314.161 that 

DIAMOX (acetazolamide) intravenous, 

500 mg base/vial, and DIAMOX 

(acetazolamide) tablets, 125 mg and 250 

mg, were not withdrawn for reasons of 

safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that DIAMOX 

(acetazolamide) intravenous, 500 mg 

base/vial, was withdrawn for reasons of 

safety or effectiveness. We have 

carefully reviewed our files for records 

concerning the withdrawal of DIAMOX 

(acetazolamide) intravenous, 500 mg 

base/vial, and DIAMOX (acetazolamide) 

tablets, 125 mg and 250 mg from sale. 

We have also independently evaluated 

relevant literature and data for possible 

postmarketing adverse events and have 

found no information that would 

indicate that these products were 


asabaliauskas on DSK4SPTVN1PROD with NOTICES
64202 Federal Register / Vol. 79, No. 208 / Tuesday, October 28, 2014 / Notices 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list DIAMOX 

(acetazolamide) intravenous, 500 mg 

base/vial, and DIAMOX (acetazolamide) 

tablets, 125 mg and 250 mg, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. FDA will not 

begin procedures to withdraw approval 

of ANDAs that refer to DIAMOX 

(acetazolamide) intravenous, 500 mg 

base/vial, and DIAMOX (acetazolamide) 

tablets, 125 mg and 250 mg. Additional 

ANDAs that refer to these products may 

also be approved by the Agency as long 

as they meet all other legal and 

regulatory requirements for the approval 

of ANDAs. If FDA determines that 

labeling for these drug products should 

be revised to meet current standards, the 

Agency will advise ANDA applicants to 

submit such labeling. 

Dated: October 21, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–25534 Filed 10–27–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request: Generic Clearance 

for Satisfaction Surveys of Customers 

(CSR) 

SUMMARY: Under the provisions of 

Section 3507(a)(l)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institutes of Health (NIH) has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. This proposed information 

collection was previously published in 

the Federal Register on August 21, 

2014, page 49523 and allowed 60 days 

for public comment. No public 

comments were received. The purpose 

of this notice is to allow an additional 

30 days for public comment. The Center 

for Scientific Review (CSR), National 

Institutes of Health, may not conduct or 

sponsor, and the respondent is not 

required to respond to, an information 

collection that has been extended, 

revised, or implemented on or after 

October 31, 2014, unless it displays a 

currently valid OMB control number. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, OIRA_submission@

omb.eop.gov or by fax to 202–395–6974, 

Attention: NIH Desk Officer. 

DATES: Comment Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

FOR FURTHER INFORMATION CONTACT: To 

obtain a copy of the data collection 

plans and instruments, submit 

comments in writing, or request more 

information on the proposed project 

contact: Dr. Mary Ann Guadagno, 

Project Clearance Liaison, Center for 

Scientific Review, NIH, Room 3182, 

6701 Rockledge Drive, Bethesda, MD 

20892, or call non-toll-free number (301) 

435–1251 or Email your request, 

including your address to: guadagma@

csr.nih.gov. Formal requests for 

additional plans and instruments must 

be requested in writing. 

Proposed Collection: Generic 

Clearance for Satisfaction Surveys of 

Customers (CSR), 0925–0474— 

extension, Center for Scientific Review 

(CSR), National Institutes of Health 

(NIH). 

Need and Use of Information 

Collection: The information collected in 

these surveys will be used by the Center 

for Scientific Review management and 

personnel: (1) To assess the quality of 

the modified operations and processes 

now used by CSR to review grant 

applications; (2) To assess the quality of 

service provided by CSR to our 

customers; (3) To enable identification 

of the most promising biomedical 

research that will have the greatest 

impact on improving public health by 

using a peer review process that is fair 

unbiased from outside influence, timely, 

and (4) To develop new modes of 

operation based on customer need and 

customer feedback about the efficacy of 

implemented modifications. These 

surveys will almost certainly lead to 

quality improvement activities to 

enhance and/or streamline CSR’s 

operations. The major mechanism by 

which CSR will request input is through 

surveys. The major initiatives ongoing at 

the present time include: Evaluation of 

the peer review process, surveys of new 

and early stage investigators, 

satisfaction with study section meetings 

using alternative review platforms, 

quick feedback for peer review, 

satisfaction with new reviewer 

orientation sessions, teleworker space 

needs, improving study section 

alignment to ensure the best reviews, 

and others. Surveys will be collected via 

Internet or in focus groups. Information 

gathered from these surveys will be 

presented to, and used directly by, CSR 

management to enhance the operations, 

processes, organization of, and services 

provided by the Center. 

OMB approval is requested for 3 

years. There are no costs to respondents 

other than their time. The total 

estimated annualized burden hours are 

4323. 

ESTIMATED ANNUALIZED BURDEN HOURS

Form name Type of respondent Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Total annual 

burden hour 

A ............... Adult scientific professionals (via Mail/Telephone/Internet) ...... 7925 1 30/60 3963 

B ............... Adult scientific professionals (via focus groups) ....................... 240 1 90/60 360 


asabaliauskas on DSK4SPTVN1PROD with NOTICES