80_FR_17107 80 FR 17046 - Center for Scientific Review; Notice of Closed Meetings

80 FR 17046 - Center for Scientific Review; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 61 (March 31, 2015)

Page Range17046-17047
FR Document2015-07256

Federal Register, Volume 80 Issue 61 (Tuesday, March 31, 2015) 
[Federal Register Volume 80, Number 61 (Tuesday, March 31, 2015)]
[Notices]
[Pages 17046-17047]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-07256]


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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, [email protected].
    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, [email protected].
    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.


[[Page 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, [email protected].

(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

17046 Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices SUPPLEMENTARY INFORMATION: Section 4, 5, 6, and 7 were all revised. At that Dated: March 24, 2015. 106(b)(2)(B)(x) of CAPTA requires a time, Q/A 2.1A.4 #2, was deleted, but it Mark H. Greenberg, certification by the State Governor that was updated and reissued in August Acting Assistant Secretary for Children and the State has in effect and is enforcing 2013. This Q/A clarifies that when child Families. a State law, or has in effect and is abuse or neglect results in the death or [FR Doc. 2015–07390 Filed 3–30–15; 8:45 am] operating a statewide program, relating near death of a child, the State must BILLING CODE 4184–29–P to child abuse and neglect that includes provide for the disclosure of the ‘‘provisions which allow for public information required by section 2.1A.4, disclosure of the findings or information Q/A #8 of the CWPM, but that the DEPARTMENT OF HEALTH AND about the case of child abuse or neglect provision should not be interpreted to HUMAN SERVICES which has resulted in a child fatality or require disclosure of information which near fatality.’’ We revised our policy would fall within the specific National Institutes of Health interpretation of the statutory provision exceptions that states are allowed to regarding public disclosure of establish under section 2.1A.4, Q/A #8 Center for Scientific Review; Notice of information in cases of child abuse or of the CWPM. The full Q/A 2.1A.4 #2 Closed Meetings neglect which have resulted in a child can be found at: http://www.acf.hhs.gov/ Pursuant to section 10(d) of the fatality or near fatality found in section cwpm/programs/cb/laws_policies/laws/ Federal Advisory Committee Act, as 106(b)(2)(B)(x) of CAPTA in September cwpm/policy_dsp.jsp?citID=68#320. The amended (5 U.S.C. App.), notice is 2012 with the addition of CWPM history of the modified Q/A’s is also hereby given of the following meetings. question 2.1A.4 #8. This interpretation available in the CWPM at: http:// The meetings will be closed to the requires States to develop procedures www.acf.hhs.gov/cwpm/programs/cb/ public in accordance with the for the release of information including, laws_policies/laws/cwpm/policy_ provisions set forth in sections but not limited to: the cause of and dsp.jsp?citID=68#2561). 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., circumstances regarding the fatality or We seek comment from state agencies as amended. The grant applications and near fatality; the age and gender of the and other stakeholders about the revised the discussions could disclose child; information describing any policy interpretation at CWPM, section confidential trade secrets or commercial previous reports or child abuse or 2.1A.4, Q/A #8, or any other revised property such as patentable material, neglect investigations that are pertinent policies in section 2.1A of the CWPM and personal information concerning to the child abuse or neglect that led to noted above. individuals associated with the grant the fatality or near fatality; the result of We encourage stakeholder applications, the disclosure of which any such investigations; and the respondents to address the following would constitute a clearly unwarranted services provided by and actions of the questions: invasion of personal privacy. State on behalf of the child that are (1) Please describe any challenges Name of Committee: Center for Scientific pertinent to the child abuse or neglect you’ve had obtaining information about Review Special Emphasis Panel; Member that led to the fatality or near fatality. child fatalities and near fatalities which Conflict: AIDS and AIDS Related Research. States may allow exceptions to the resulted from child abuse and neglect Date: April 8, 2015. release of information in order to ensure Time: 11:00 a.m. to 5:00 p.m. from a state. Have there been Agenda: To review and evaluate grant the safety and well-being of the child, improvements in obtaining the parents and family or when releasing applications. information since CB revised the policy Place: National Institutes of Health, 6701 the information would jeopardize a in CWPM section 2.1.A in September Rockledge Drive, Bethesda, MD 20892, criminal investigation, interfere with the 2012? (Telephone Conference Call). protection of those who report child Contact Person: Mary Clare Walker, Ph.D., (2) What concerns, if any, do you have abuse or neglect or harm the child or the Scientific Review Officer, Center for with the definition of near fatalities in child’s family. States must also ensure Scientific Review, National Institutes of a state? Health, 6701 Rockledge Drive, Room 5208, compliance with other federal confidentiality restrictions when (3) Has a state responded that the state MSC 7852, Bethesda, MD 20892, (301) 435– implementing the confidentiality cannot disclose information due to 1165, walkermc@csr.nih.gov. confidentiality protections? If so, This notice is being published less than 15 provisions under CAPTA, including the days prior to the meeting due to the timing confidentiality requirements applicable describe the information requested and the confidentiality provision cited by limitations imposed by the review and to titles IV–B and IV–E of the Social funding cycle. Security Act (the Act) and in accordance the state. Name of Committee: Center for Scientific with 45 CFR 1355.30, which requires (4) Does your state offer a public Review Special Emphasis Panel; Topics in that records maintained under title IV– report of the child fatalities review Bacterial Pathogenesis. E and IV–B of the Act are subject to the panel/commission? If so, does the report Date: April 9, 2015. confidentiality provisions in 45 CFR contain the required disclosure of Time: 10:00 a.m. to 11:00 a.m. 205.50. Among other things, 45 CFR information? Is the report a barrier to Agenda: To review and evaluate grant 205.50 restricts the release or use of obtaining information? applications. Place: National Institutes of Health, 6701 information concerning individuals We encourage state agency Rockledge Drive, Bethesda, MD 20892, receiving financial assistance under respondents to address the following (Telephone Conference Call). these programs to certain persons or questions: Contact Person: Marci Scidmore, Ph.D., asabaliauskas on DSK5VPTVN1PROD with NOTICES agencies that require the information for (1) What challenges, if any, have you Scientific Review Officer, Center for specified purposes. faced implementing the revised policy? Scientific Review, National Institutes of We also revised several CWPM Has the revised policy improved your Health, 6701 Rockledge Drive, Room 3192, disclosure process and policies? MSC 7808, Bethesda, MD 20892, 301–435– answers in section 2.1A to bring them 1149, marci.scidmore@nih.gov. in line with the policy as outlined in the (2) Are there challenges in applying This notice is being published less than 15 new question and answer (Q/A). CWPM the disclosure policy while also days prior to the meeting due to the timing section 2.1A.1, questions 1, 2, 6, and 8; ensuring that you adhere to limitations imposed by the review and and CWPM section 2.1A.4, questions 3, confidentiality protections? funding cycle. VerDate Sep<11>2014 19:34 Mar 30, 2015 Jkt 235001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\FR\FM\31MRN1.SGM 31MRN1

Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices 17047 Name of Committee: Center for Scientific Standards Resources Web site at analyze concomitant medications taken Review Special Emphasis Panel; Member http://www.fda.gov/forindustry/ by subjects during the course of clinical Conflict: Hypertension, Thrombosis, Vascular datastandards/studydatastandards/ trials. Inflammation and Dysfunction. Although use of WHO Drug default.htm Date: April 23–24, 2015. Time: 8:00 a.m. to 5:00 p.m. DATES: Although you can comment on Dictionary codes are not required at this Agenda: To review and evaluate grant this notice at any time, to ensure that time, FDA now supports and encourages applications. the Agency considers your comments the use of WHO Drug Dictionary coded Place:National Institutes of Health, 6701 submit either electronic or written concomitant medications used in Rockledge Drive, Bethesda, MD 20892, comments by May 5, 2015. clinical trials. For purposes of this (Virtual Meeting). notice, ‘‘supported’’ means the receiving Contact Person: Natalia Komissarova, ADDRESSES: Submit written requests for Center has established processes and Ph.D., Scientific Review Officer, Center for single copies of the documents to the technology to support receiving, Scientific Review, National Institutes of Division of Drug Information, Center for Health, 6701 Rockledge Drive, Room 5207, processing, reviewing, and archiving Drug Evaluation and Research, Food MSC 7846, Bethesda, MD 20892, 301–435– files in the specified standard. and Drug Administration, 10001 New FDA is now encouraging sponsors and 1206, komissar@mail.nih.gov. Hampshire Ave., Hillandale Building, (Catalogue of Federal Domestic Assistance applicants to provide WHO Drug 4th Floor, Silver Spring, MD 20993– Dictionary codes for concomitant Program Nos. 93.306, Comparative Medicine; 0002 or the Office of Communication, 93.333, Clinical Research, 93.306, 93.333, medication data in investigational 93.337, 93.393–93.396, 93.837–93.844, Outreach, and Development, Center for studies provided in regulatory 93.846–93.878, 93.892, 93.893, National Biologics Evaluation and Research, submissions (e.g., investigational new Institutes of Health, HHS). Food and Drug Administration, 10903 drug applications, new drug New Hampshire Ave., Bldg. 71, Rm. applications, abbreviated new drug Dated: March 25, 2015. 3128, Silver Spring, MD 20993–0002. applications, and biologics license David Clary, Send one self-addressed adhesive label Program Analyst, Office of Federal Advisory applications). The codes should include to assist that office in processing your Committee Policy. the drug product trade name where requests. [FR Doc. 2015–07256 Filed 3–30–15; 8:45 am] Submit electronic comments to http:// available, the active ingredient(s) and BILLING CODE 4140–01–P www.regulations.gov. Submit written the ATC class. comments to the Division of Dockets II. Comments Management (HFA–305), Food and Drug Interested persons may submit either DEPARTMENT OF HEALTH AND Administration, 5630 Fishers Lane, Rm. HUMAN SERVICES electronic comments to http:// 1061, Rockville, MD 20852. www.regulations.gov or written FOR FURTHER INFORMATION CONTACT: Ron comments regarding this notice to the Food and Drug Administration Fitzmartin, Center for Drug Evaluation Division of Dockets Management (see [Docket No. FDA–2015–N–0815] and Research, Food and Drug ADDRESSES). It is only necessary to send Administration, 10903 New Hampshire one set of comments. Identify comments Electronic Study Data Submission; Ave. Bldg. 51, rm. 1192, Silver Spring, Data Standards; Recommending the with the docket number found in MD 20993–002, brackets in the heading of this Use of the World Health Organization ronald.fitzmartin@fda.hhs.gov; or Drug Dictionary document. Received comments may be Stephen Ripley, Center for Biologics seen in the Division of Dockets AGENCY: Food and Drug Administration, Evaluation and Research, Food and Management between 9 a.m. and 4 p.m., HHS. Drug Administration, 10903 New Monday through Friday, and will be ACTION: Notice. Hampshire Ave. Bldg. 71, Rm. 7301, posted to the docket at http:// Silver Spring, MD 20993, www.regulations.gov. SUMMARY: The Food and Drug stephen.ripley@fda.hhs.gov. Dated: March 23, 2015. Administration (FDA or Agency) is SUPPLEMENTARY INFORMATION: announcing support for the World Leslie Kux, Health Organization (WHO) Drug I. Background Associate Commissioner for Policy. Dictionary (available at http:// The use of a common dictionary to [FR Doc. 2015–07269 Filed 3–30–15; 8:45 am] www.who-umc.org/), which is code concomitant medications is an BILLING CODE 4164–01–P maintained and updated by the Uppsala important component of study data Monitoring Centre. FDA is encouraging standardization. Generally, controlled sponsors and applicants to use WHO terminology standards specify the key DEPARTMENT OF HEALTH AND Drug Dictionary codes in investigational concepts that are represented as HUMAN SERVICES study data provided in regulatory definitions, preferred terms, synonyms, Food and Drug Administration submissions to the Center for Drug codes, and code system. The analysis of Evaluation and Research and to the study data is greatly facilitated by the [Docket No. FDA–2015–D–0839] Center for Biologics Evaluation and use of controlled terms for clinical or Research. The WHO Drug Dictionary scientific concepts that have standard, Target Animal Safety Data contains unique codes for identifying predefined meanings and Presentation and Statistical Analysis; drug names and evaluating medicinal representations. WHO Drug Dictionary Draft Guidance for Industry; asabaliauskas on DSK5VPTVN1PROD with NOTICES product information, including active contains unique codes as drug names Availability ingredients and therapeutic uses. and corresponding medicinal product AGENCY: Food and Drug Administration, Typically, WHO Drug Dictionary is used information, including active HHS. to code concomitant medications used ingredients and the Anatomical ACTION: Notice. by subjects during the course of a Therapeutic Chemical (ATC) clinical trial. WHO Drug Dictionary will classification system for the therapeutic SUMMARY: The Food and Drug be listed in the FDA Data Standards uses. Typically, sponsors and applicants Administration (FDA) is announcing the Catalog posted to FDA’s Study Data use WHO Drug Dictionary to code and availability of a draft guidance for VerDate Sep<11>2014 18:32 Mar 30, 2015 Jkt 235001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\FR\FM\31MRN1.SGM 31MRN1


Document Created: 2015-12-18 11:47:51
Document Modified: 2015-12-18 11:47:51
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
DatesApril 8, 2015.
FR Citation80 FR 17046 
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