Proposed Data Collections Submitted for Public Comment and Recommendations, 64200-64201 [2014-25562]

Download as PDF 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 asabaliauskas on DSK4SPTVN1PROD with NOTICES 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 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. 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. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of respondents Form name Refugee ................................. Refugee ................................. Focus Group Discussion Tool ...................... Survey Tool .................................................. VerDate Sep<11>2014 20:06 Oct 27, 2014 Jkt 235001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 Number of responses per respondent 16 370 E:\FR\FM\28OCN1.SGM 1 1 28OCN1 Average burden per response (in hours) Total burden hours 1 1 16 370 Federal Register / Vol. 79, No. 208 / Tuesday, October 28, 2014 / Notices 64201 ESTIMATED ANNUALIZED BURDEN HOURS—Continued Form name Number of respondents Number of responses per respondent Average burden per response (in hours) ....................................................................... ........................ ........................ ........................ Type of respondents Total ............................... 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. 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 asabaliauskas on DSK4SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 20:06 Oct 27, 2014 Jkt 235001 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 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 Total burden hours 386 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 E:\FR\FM\28OCN1.SGM 28OCN1

Agencies

[Federal Register Volume 79, Number 208 (Tuesday, October 28, 2014)]
[Notices]
[Pages 64200-64201]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-25562]


-----------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per  response   Total burden
                                                    respondents     respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Refugee.......................  Focus Group                   16               1               1              16
                                 Discussion Tool.
Refugee.......................  Survey Tool.....             370               1               1             370
                                                 ---------------------------------------------------------------

[[Page 64201]]

 
    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