64200 Federal Register / Vol. 79, No. 208 / Tuesday, October 28, 2014 / Notices 

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. 2014–25563 Filed 10–27–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–15–15CI] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

The Centers for Disease Control and 

Prevention (CDC), as part of its 

continuing effort to reduce public 

burden, invites the general public and 

other Federal agencies to take this 

opportunity to comment on proposed 

and/or continuing information 

collections, as required by the 

Paperwork Reduction Act of 1995. To 

request more information on the below 

proposed project or to obtain a copy of 

the information collection plan and 

instruments, call 404–639–7570 or send 

comments to Leroy A. Richardson, 1600 

Clifton Road, MS–D74, Atlanta, GA 

30333 or send an email to omb@cdc.gov. 

Comments submitted in response to 

this notice will be summarized and/or 

included in the request for Office of 

Management and Budget (OMB) 

approval. Comments are invited on: (a) 

Whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; (d) ways to 

minimize the burden of the collection of 

information on respondents, including 

through the use of automated collection 

techniques or other forms of information 

technology; and (e) estimates of capital 

or start-up costs and costs of operation, 

maintenance, and purchase of services 

to provide information. Burden means 

the total time, effort, or financial 

resources expended by persons to 

generate, maintain, retain, disclose or 

provide information to or for a Federal 

agency. This includes the time needed 

to review instructions; to develop, 

acquire, install and utilize technology 

and systems for the purpose of 

collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information, to search 

data sources, to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Mental Health Profile of Congolese 

Refugees—New—National Center for 

Emerging and Zoonotic Infectious 

Diseases (NCEZID), Centers for Disease 

Control and Prevention (CDC). 

Background and Brief Description 

The central objective of this collection 

is to compile a mental health profile of 

Congolese refugees departing from 

Uganda, and to describe some of the 

mental health conditions most often 

experienced by this population. The 

specific objectives are (1) through a 

survey and focus groups, collect more 

detailed and systematic data on 

exposure to trauma and symptoms of 

PTSD, anxiety, and depression among a 

sample of Congolese refugees from 

Uganda prior to their resettlement in the 

United States; and, (2) to better inform 

state and local healthcare providers in 

the United States and in Uganda about 

the mental health needs of the 

Congolese refugee populations come to 

their states. As CDC have seen in 

previous surveys, although there may be 

similarities in the mental health 

problems that refugee populations may 

experience over all, there are also very 

specific differences in terms of cultural 

background, coping styles, severity, and 

risk factors. Without doing a survey, it 

would not be possible to provide 

specific recommendations for Congolese 

refugees who are coming to the U.S. 

The respondents in this study will be 

Congolese refugees 15 years of age or 

older who have been referred for U.S. 

resettlement in settlement and urban 

sites in Uganda and who consent to a 

supplemental mental health assessment 

after their required overseas medical 

exam or security screening interview. 

Individual level data will not be 

collected. Aggregated data will collected 

during focus groups and surveys to form 

a ‘profile’ of Congolese refugee 

regarding their levels of anxiety, 

depression, PTSD, ability to cope, 

physical functioning, bodily pain, role 

limitations due to physical health 

problems, role limitations due to 

personal or emotional problems, 

emotional well-being, and social 

function. 

The focus group discussion tool poses 

eight open-ended questions and will be 

moderated by a professional in the 

appropriate language for the specific 

Congolese refugee group. 

For the survey tool, CDC proposes to 

the use a compilation of the Hopkins 

Symptom Checklist, Harvard Trauma 

Questionnaire, the Medical Outcomes 

Assessment 36-Item Short-Form Health 

Survey (SF–36), a limited number of 

questions from The Coping Strategy 

Indicator, and questions concerning 

history of mental illness or substance 

abuse. Each of these tools has been used 

in similar populations that have 

experienced trauma or in conflict 

environments. 

The sample population will be a 

convenience sample of the Congolese 

refugee population ages 15 or older in 

Uganda and will be selected from the 

available population being examined 

during the International Organization 

for Migration (IOM) medical or 

Resettlement Support Center (RSC) 

screening interviews. As refugees are 

waiting for their IOM exam or RSC 

interview, staff will introduce the 

assessment with the help of an 

interpreter, and make arrangements for 

obtaining consent from refugees who 

meet the inclusion and exclusion 

criteria prior to the assessment. 

There is no cost to respondents other 

than their time. The total estimated 

annualized burden hours are 386. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Refugee ................................. Focus Group Discussion Tool ...................... 16 1 1 16 

Refugee ................................. Survey Tool .................................................. 370 1 1 370 


asabaliauskas on DSK4SPTVN1PROD with NOTICES
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 


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