Federal Register / Vol. 80, No. 3 / Tuesday, January 6, 2015 / Notices 507 

instrumental in bringing attention to 

emerging issues in chronic HIV 

infection with actionable opportunities 

for prevention, including cardiovascular 

disease, fragility fractures, renal and 

hepatic disease, and cancers. The HOPS 

remains an important source for multiyear trend data concerning conditions 

and behaviors for which data are not 

readily available elsewhere, including: 

Rates of opportunistic illnesses, rates of 

comorbid conditions (e.g., hypertension, 

obesity, diabetes) and antiretroviral drug 

resistance. 

Data will be collected through 

medical record abstraction by trained 

abstractors and by telephone or internetbased, computer-assisted interviews at 

nine funded study sites in six U.S. 

cities. Collection of data abstracted from 

patient medical records provides data in 

five general categories: Demographics 

and risk behaviors for HIV infection; 

symptoms; diagnosed conditions 

(definitive and presumptive); 

medications prescribed (including dose, 

duration, and reasons for stopping); all 

laboratory values, including CD4+ Tlymphocyte (CD4+) cell counts, plasma 

HIV–RNA determinations, and 

genotype, phenotype, and trophile 

results. Data on visit frequency, AIDS, 

and death are acquired from the clinic 

chart. 

Data collected using a brief Telephone 

Audio-Computer Assisted SelfInterview (T–ACASI) survey or an 

identical Web-based Audio-Computer 

Assisted Self-Interview (ACASI) 

include: Age, sex at birth, use of alcohol 

and drugs, cigarette smoking, adherence 

to antiretroviral medications, types of 

sexual intercourse, condom use, and 

disclosure of HIV status to partners. 

We anticipate that 450 new HOPS 

study participants will be recruited 

annually into the HOPS from a pool of 

HIV-infected individuals currently in 

HIV-care at the nine aforementioned 

clinics (50 patients per site). Patients are 

approached during one of their routine 

clinic visits to participate in the HOPS. 

Patients interested in participating in 

the HOPS are given detailed information 

about the nature of the study and 

provided with written informed consent 

that must be completed prior to 

enrollment. 

The 450 newly enrolled participants 

each year will be added to the database 

of existing participants such that 

approximately 2,500 participants will be 

seen in the HOPS each year. Medical 

record abstractions will be completed 

on all HOPS participants, and impose 

no direct burden on HOPS study 

participants. 

Participation of respondents is 

voluntary. There is no cost to the 

respondents other than their time. 

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 

(in hours) 

HOPS study Patients ........................ Consent form .................................... 450 1 15/60 113 

HOPS Study Patients ....................... Behavioral survey ............................. 2,500 1 7/60 292 

Total ........................................... ........................................................... ........................ ........................ ........................ 405 

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. 2014–30889 Filed 1–5–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

[CFDA Number: 93.604] 

Announcement of the Award of an 

Urgent Single-Source Grant to the 

Center for Survivors of Torture in 

Dallas, TX. 

AGENCY: Office of Refugee Resettlement, 

ACF, HHS. 

ACTION: Announcement of the award of 

an urgent single-source grant to the 

Center for Survivors of Torture to 

provide mental health services for 

victims of torture. 

SUMMARY: The Administration for 

Children and Families (ACF), Office of 

Refugee Resettlement (ORR) announces 

the award of an urgent single-source 

grant in the amount of $250,000 to the 

Center for Survivors of Torture (CST) in 

Dallas, TX, to ensure incoming refugee 

populations in Texas have access to 

mental health services. 

DATES: The project period for the award 

is July 1, 2014 through September 29, 

2015. 

FOR FURTHER INFORMATION CONTACT: 

Kenneth Tota, Deputy Director, Office of 

Refugee Resettlement, 901 D. Street 

SW., Washington, DC 20047. Telephone: 

202–401–4858. Email: kenneth.tota@

acf.hhs.gov. 

SUPPLEMENTARY INFORMATION: CST is the 

only accredited mental health care 

provider of specialized torture survivor 

mental health treatment services in 

Texas and the surrounding area. Many 

refugees have been victims of torture. 

Approximately 48,000 individual 

refugees reside in the areas covered by 

CST. Texas is a top resettlement 

location with one of the highest 

concentrations of refugees in the United 

States. In the past few years, an 

increasing need for mental health 

services has been associated with 

refugee populations from Iraq, Burma, 

and Bhutan who have suffered trauma 

and torture due to war and genocide in 

those countries. Currently, the U.S. 

refugee resettlement program is seeing a 

rise in refugees from the Democratic 

Republic of Congo (DRC). The United 

Nations High Commissioner for 

Refugees has determined this group is 

particularly at risk due to decades of 

extreme violence in DRC and recent 

arrivals have shown a compelling need 

for mental health services upon 

resettlement. 

CST services are critical to meeting 

the mental health needs of individuals 

who have survived torture. They 

provide evaluation and counseling to 

children, adolescents, adults, couples, 

and families. Additionally, CST offers 

group therapy, psychosocial activities, 

and medication management. In 

addition to these direct services, CST 

also provides training on refugee mental 

health issues to other organizations in 

the area, including schools, health 

clinics, and social services agencies. 

During the period of April 1, 2013 

through March 31, 2014, CST provided 

free comprehensive mental health 

services to 355 ORR clients. More than 

82 percent of these clients experienced 

a reduction in symptoms. 


tkelley on DSK3SPTVN1PROD with NOTICES
508 Federal Register / Vol. 80, No. 3 / Tuesday, January 6, 2015 / Notices 

Statutory Authority: Section 5(a) of the 

‘‘Torture Victims Relief Act of 1998,’’ Public 

Law 105–320 (22 U.S.C. 2152 note). 

Melody Wayland, 

Senior Grants Policy Specialist, Office of 

Administration. 

[FR Doc. 2014–30906 Filed 1–5–15; 8:45 am] 

BILLING CODE 4184–46–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1081] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry on Postmarketing Adverse 

Event Reporting for Medical Products 

and Dietary Supplements During an 

Influenza Pandemic; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995 

(the PRA). 

DATES: Fax written comments on the 

collection of information by February 5, 

2015. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0701. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Guidance for Industry on 

Postmarketing Adverse Event Reporting 

for Medical Products and Dietary 

Supplements During an Influenza 

Pandemic; Availability (OMB Control 

Number 0910–0701)—Extension 

The guidance includes 

recommendations for planning, 

notification, and documentation for 

firms that report postmarketing adverse 

events. The guidance recommends that 

each firm’s pandemic influenza 

continuity of operations plan (COOP) 

include instructions for reporting 

adverse events, including a plan for the 

submission of stored reports that were 

not submitted within regulatory 

timeframes. The guidance explains that 

firms that are unable to fulfill normal 

adverse event reporting requirements 

during an influenza pandemic should: 

(1) Maintain documentation of the 

conditions that prevent them from 

meeting normal reporting requirements; 

(2) notify the appropriate FDA 

organizational unit responsible for 

adverse event reporting compliance 

when the conditions exist and when the 

reporting process is restored; and (3) 

maintain records to identify what 

reports have been stored. 

Based on the number of 

manufacturers that would be covered by 

the guidance, we estimate that 

approximately 5,000 firms will add the 

following to their COOP: (1) Instructions 

for reporting adverse events; and (2) a 

plan for submitting stored reports that 

were not submitted within regulatory 

timeframes. We estimate that each firm 

will take approximately 50 hours to 

prepare the adverse event reporting plan 

for its COOP. 

We estimate that approximately 500 

firms will be unable to fulfill normal 

adverse event reporting requirements 

because of conditions caused by an 

influenza pandemic and that these firms 

will notify the appropriate FDA 

organizational unit responsible for 

adverse event reporting compliance 

when the conditions exist. Although we 

do not anticipate such pandemic 

influenza conditions to occur every 

year, for purposes of the PRA, we 

estimate that each of these firms will 

notify FDA approximately once each 

year, and that each notification will take 

approximately 8 hours to prepare and 

submit. 

Concerning the recommendation in 

the guidance that firms unable to fulfill 

normal adverse event reporting 

requirements maintain documentation 

of the conditions that prevent them from 

meeting these requirements, 

maintaining records to identify what 

adverse event reports have been stored, 

and when the reporting process is 

restored. We estimate that 

approximately 500 firms will each need 

approximately 8 hours to maintain the 

documentation and approximately 500 

firms will each need approximately 8 

hours to maintain the records. 

Therefore, the total recordkeeping 

burden that would result from the 

guidance would be 258,000 hours. 

The guidance also refers to previously 

approved collections of information 

found in FDA’s adverse event reporting 

requirements in 21 CFR 310.305, 314.80, 

314.98, 600.80, 606.170, 640.73, 

1271.350, and part 803. These 

regulations contain collections of 

information that are subject to review by 

OMB under the PRA (44 U.S.C. 3501– 

3520) and are approved under OMB 

control numbers 0910–0116, 0910–0291, 

0910–0230, 0910–0308, 0910–0437, and 

0910–0543. In addition, the guidance 

also refers to adverse event reports for 

nonprescription human drug products 

marketed without an approved 

application and dietary supplements 

required under sections 760 and 761 of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 379aa and 379aa–1), 

which include collections of 

information approved under OMB 

control numbers 0910–0636 and 0910– 

0635. 

In the Federal Register of August 11, 

2014 (79 FR 46839), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. We received one comment. 

The comment said that during an 

influenza pandemic, FDA should not 

put forth a policy of reduced reporting, 

especially for newly approved drugs 

and vaccines. The comment 

recommended that FDA ask companies 

to modify their contingency plans by 

either leveraging the company’s remote 

call center locations not affected by the 

pandemic or by outsourcing their safety 

reporting to such locations. The 

comment stated that at minimum, FDA 

should require weekly reporting or 

establish a threshold number of reports 

that a company must report to FDA. The 

comment added that FDA should 

specifically require reporting on newly 

approved drugs or vaccines for which 

there is little safety information. 

FDA response: The Guidance for 

Industry on Postmarketing Adverse 

Event Reporting for Medical Products 

and Dietary Supplements During an 

Influenza Pandemic does not describe 

an approach of reduced reporting during 

an influenza pandemic. Rather, the 

guidance states that ‘‘normal adverse 

event reporting processes should be 

maintained to the maximum extent 

possible’’ (see section III.C.1, page 3). 


tkelley on DSK3SPTVN1PROD with NOTICES