17046 Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices 

SUPPLEMENTARY INFORMATION: Section 

106(b)(2)(B)(x) of CAPTA requires a 

certification by the State Governor that 

the State has in effect and is enforcing 

a State law, or has in effect and is 

operating a statewide program, relating 

to child abuse and neglect that includes 

‘‘provisions which allow for public 

disclosure of the findings or information 

about the case of child abuse or neglect 

which has resulted in a child fatality or 

near fatality.’’ We revised our policy 

interpretation of the statutory provision 

regarding public disclosure of 

information in cases of child abuse or 

neglect which have resulted in a child 

fatality or near fatality found in section 

106(b)(2)(B)(x) of CAPTA in September 

2012 with the addition of CWPM 

question 2.1A.4 #8. This interpretation 

requires States to develop procedures 

for the release of information including, 

but not limited to: the cause of and 

circumstances regarding the fatality or 

near fatality; the age and gender of the 

child; information describing any 

previous reports or child abuse or 

neglect investigations that are pertinent 

to the child abuse or neglect that led to 

the fatality or near fatality; the result of 

any such investigations; and the 

services provided by and actions of the 

State on behalf of the child that are 

pertinent to the child abuse or neglect 

that led to the fatality or near fatality. 

States may allow exceptions to the 

release of information in order to ensure 

the safety and well-being of the child, 

parents and family or when releasing 

the information would jeopardize a 

criminal investigation, interfere with the 

protection of those who report child 

abuse or neglect or harm the child or the 

child’s family. States must also ensure 

compliance with other federal 

confidentiality restrictions when 

implementing the confidentiality 

provisions under CAPTA, including the 

confidentiality requirements applicable 

to titles IV–B and IV–E of the Social 

Security Act (the Act) and in accordance 

with 45 CFR 1355.30, which requires 

that records maintained under title IV– 

E and IV–B of the Act are subject to the 

confidentiality provisions in 45 CFR 

205.50. Among other things, 45 CFR 

205.50 restricts the release or use of 

information concerning individuals 

receiving financial assistance under 

these programs to certain persons or 

agencies that require the information for 

specified purposes. 

We also revised several CWPM 

answers in section 2.1A to bring them 

in line with the policy as outlined in the 

new question and answer (Q/A). CWPM 

section 2.1A.1, questions 1, 2, 6, and 8; 

and CWPM section 2.1A.4, questions 3, 

4, 5, 6, and 7 were all revised. At that 

time, Q/A 2.1A.4 #2, was deleted, but it 

was updated and reissued in August 

2013. This Q/A clarifies that when child 

abuse or neglect results in the death or 

near death of a child, the State must 

provide for the disclosure of the 

information required by section 2.1A.4, 

Q/A #8 of the CWPM, but that the 

provision should not be interpreted to 

require disclosure of information which 

would fall within the specific 

exceptions that states are allowed to 

establish under section 2.1A.4, Q/A #8 

of the CWPM. The full Q/A 2.1A.4 #2 

can be found at: http://www.acf.hhs.gov/ 

cwpm/programs/cb/laws_policies/laws/

cwpm/policy_dsp.jsp?citID=68#320. The 

history of the modified Q/A’s is also 

available in the CWPM at: http://

www.acf.hhs.gov/cwpm/programs/cb/

laws_policies/laws/cwpm/policy_

dsp.jsp?citID=68#2561). 

We seek comment from state agencies 

and other stakeholders about the revised 

policy interpretation at CWPM, section 

2.1A.4, Q/A #8, or any other revised 

policies in section 2.1A of the CWPM 

noted above. 

We encourage stakeholder 

respondents to address the following 

questions: 

(1) Please describe any challenges 

you’ve had obtaining information about 

child fatalities and near fatalities which 

resulted from child abuse and neglect 

from a state. Have there been 

improvements in obtaining the 

information since CB revised the policy 

in CWPM section 2.1.A in September 

2012? 

(2) What concerns, if any, do you have 

with the definition of near fatalities in 

a state? 

(3) Has a state responded that the state 

cannot disclose information due to 

confidentiality protections? If so, 

describe the information requested and 

the confidentiality provision cited by 

the state. 

(4) Does your state offer a public 

report of the child fatalities review 

panel/commission? If so, does the report 

contain the required disclosure of 

information? Is the report a barrier to 

obtaining information? 

We encourage state agency 

respondents to address the following 

questions: 

(1) What challenges, if any, have you 

faced implementing the revised policy? 

Has the revised policy improved your 

disclosure process and policies? 

(2) Are there challenges in applying 

the disclosure policy while also 

ensuring that you adhere to 

confidentiality protections? 

Dated: March 24, 2015. 

Mark H. Greenberg, 

Acting Assistant Secretary for Children and 

Families. 

[FR Doc. 2015–07390 Filed 3–30–15; 8:45 am] 

BILLING CODE 4184–29–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: AIDS and AIDS Related Research. 

Date: April 8, 2015. 

Time: 11:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Mary Clare Walker, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5208, 

MSC 7852, Bethesda, MD 20892, (301) 435– 

1165, walkermc@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Topics in 

Bacterial Pathogenesis. 

Date: April 9, 2015. 

Time: 10:00 a.m. to 11:00 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Marci Scidmore, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3192, 

MSC 7808, Bethesda, MD 20892, 301–435– 

1149, marci.scidmore@nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices 17047 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Hypertension, Thrombosis, Vascular 

Inflammation and Dysfunction. 

Date: April 23–24, 2015. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place:National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact Person: Natalia Komissarova, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5207, 

MSC 7846, Bethesda, MD 20892, 301–435– 

1206, komissar@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS). 

Dated: March 25, 2015. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–07256 Filed 3–30–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0815] 

Electronic Study Data Submission; 

Data Standards; Recommending the 

Use of the World Health Organization 

Drug Dictionary 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing support for the World 

Health Organization (WHO) Drug 

Dictionary (available at http:// 

www.who-umc.org/), which is 

maintained and updated by the Uppsala 

Monitoring Centre. FDA is encouraging 

sponsors and applicants to use WHO 

Drug Dictionary codes in investigational 

study data provided in regulatory 

submissions to the Center for Drug 

Evaluation and Research and to the 

Center for Biologics Evaluation and 

Research. The WHO Drug Dictionary 

contains unique codes for identifying 

drug names and evaluating medicinal 

product information, including active 

ingredients and therapeutic uses. 

Typically, WHO Drug Dictionary is used 

to code concomitant medications used 

by subjects during the course of a 

clinical trial. WHO Drug Dictionary will 

be listed in the FDA Data Standards 

Catalog posted to FDA’s Study Data 

Standards Resources Web site at 

http://www.fda.gov/forindustry/ 

datastandards/studydatastandards/ 

default.htm 

DATES: Although you can comment on 

this notice at any time, to ensure that 

the Agency considers your comments 

submit either electronic or written 

comments by May 5, 2015. 

ADDRESSES: Submit written requests for 

single copies of the documents to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002 or the Office of Communication, 

Outreach, and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. 

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. 

FOR FURTHER INFORMATION CONTACT: Ron 

Fitzmartin, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave. Bldg. 51, rm. 1192, Silver Spring, 

MD 20993–002, 

ronald.fitzmartin@fda.hhs.gov; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave. Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993, 

stephen.ripley@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The use of a common dictionary to 

code concomitant medications is an 

important component of study data 

standardization. Generally, controlled 

terminology standards specify the key 

concepts that are represented as 

definitions, preferred terms, synonyms, 

codes, and code system. The analysis of 

study data is greatly facilitated by the 

use of controlled terms for clinical or 

scientific concepts that have standard, 

predefined meanings and 

representations. WHO Drug Dictionary 

contains unique codes as drug names 

and corresponding medicinal product 

information, including active 

ingredients and the Anatomical 

Therapeutic Chemical (ATC) 

classification system for the therapeutic 

uses. Typically, sponsors and applicants 

use WHO Drug Dictionary to code and 

analyze concomitant medications taken 

by subjects during the course of clinical 

trials. 

Although use of WHO Drug 

Dictionary codes are not required at this 

time, FDA now supports and encourages 

the use of WHO Drug Dictionary coded 

concomitant medications used in 

clinical trials. For purposes of this 

notice, ‘‘supported’’ means the receiving 

Center has established processes and 

technology to support receiving, 

processing, reviewing, and archiving 

files in the specified standard. 

FDA is now encouraging sponsors and 

applicants to provide WHO Drug 

Dictionary codes for concomitant 

medication data in investigational 

studies provided in regulatory 

submissions (e.g., investigational new 

drug applications, new drug 

applications, abbreviated new drug 

applications, and biologics license 

applications). The codes should include 

the drug product trade name where 

available, the active ingredient(s) and 

the ATC class. 

II. Comments 

Interested persons may submit either 

electronic comments to http:// 

www.regulations.gov or written 

comments regarding this notice 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: March 23, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07269 Filed 3–30–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–0839] 

Target Animal Safety Data 

Presentation and Statistical Analysis; 

Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 


asabaliauskas on DSK5VPTVN1PROD with NOTICES