80 FR 12499 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 45 (March 9, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 45 (March 9, 2015)
| Page Range | 12499-12500 | |
| FR Document | 2015-05311 |
[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)] [Notices] [Pages 12499-12500] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-05311] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting 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 meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections [[Page 12500]] 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: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, Ancillary Study on IBD. Date: April 8, 2015. Time: 4:30 p.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Maria E. Davila-Bloom, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 758, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 594-7637, [email protected]. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: March 3, 2015. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015-05311 Filed 3-6-15; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 12499
St. NW., Washington, DC 20005, 267– submitting comments related to this the same (or closely related) within the
765–1029, Rasika.Kalamegham@ public workshop is April 23, 2015. drug class, there may be differences
aacr.org. Regardless of attendance at the public between the companion diagnostics in
Registration: Registration is free and workshop, interested persons may design and performance, such as use of
available on a first-come, first-served submit either electronic comments different antibodies or different cut-off
basis. Persons interested in attending regarding this document to http:// values leading to designation of
the ‘‘Complexities in Personalized www.regulations.gov or written different sets of marker-positive and
Medicine: Harmonizing Companion comments to the Division of Dockets marker-negative patients.
Diagnostics Across a Class of Targeted Management (HFA–305), Food and Drug Comparison of the results from
Therapies’’ public workshop must Administration, 5630 Fishers Lane, rm. different tests is not part of the
register online by March 17, 2015, 5 1061, Rockville, MD 20852. It is only companies’ development program for
p.m. Registration will be handled necessary to send one set of comments. each drug/test pair. Likewise,
through ASCO. Early registration is Identify comments with the docket differences in results from distinct tests
recommended because facilities are number found in brackets in the are typically not examined for their
limited and, therefore, we may limit the heading of this document. Received effect on efficacy of products within the
number of participants from each comments may be seen in the Division drug class. With no assurance that all
organization. If time and space permits, of Dockets Management between 9 a.m. the tests identify the populations most
onsite registration on the day of the and 4 p.m., Monday through Friday and likely to respond to all of the drugs,
public workshop will be provided will be posted to the docket at http:// problems may arise if various
beginning at 7 a.m. www.regulations.gov. companion diagnostics for the same
If you need special accommodations Transcript: Please be advised that as biomarker are used in clinical practice
due to a disability, please contact soon as a transcript is available, it will to direct treatment with all the targeted
Kaitlyn Antonelli (see Contact Persons), be accessible at http:// therapies in the drug class. Using
571–483–1606, Kaitlyn.Antonelli@ www.regulations.gov. It may be viewed multiple companion diagnostics to
asco.org, no later than March 10, 2015. at the Division of Dockets Management determine therapy for each patient is
To register for the public workshop, (see Comments). A transcript will also costly, inefficient, and challenging
please use the following Web site: be available in either hardcopy or on when dealing with a limited biological
https://www.surveymonkey.com/s/ CD–ROM, after submission of a specimen. Even if it were practical,
FDACompanionDiagnostics2015. Please Freedom of Information request. Written multiple testing might lead to
provide complete contact information requests are to be sent to the Division suboptimal use of the drugs. Likewise,
for each attendee, including name, title, of Freedom of Information (ELEM– use of one companion diagnostic might
affiliation, email, and telephone 1029), Food and Drug Administration, not adequately inform the use of all of
number. Those without Internet access 12420 Parklawn Dr., Element Bldg., the targeted therapies. In such scenarios,
should contact Kaitlyn Antonelli to Rockville, MD 20857. A link to the where multiple targeted therapy-
register. Registrants will receive transcripts will also be available companion diagnostic pairs exist,
confirmation after they have been approximately 45 days after the public patients may not be able to receive
accepted. You will be notified if you are workshop on the Internet at http:// optimal care. FDA believes this is an
on a waiting list. www.fda.gov/MedicalDevices/ important public health issue that is not
Streaming Audiocast of the Public NewsEvents/WorkshopsConferences/ easily resolved. Thus, FDA is convening
Workshop: This public workshop will default.htm. (Select this public this workshop in association with
also be audiocast. Persons interested in workshop from the posted events list.) AACR and ASCO to foster a
accessing the audiocast must register SUPPLEMENTARY INFORMATION: Multiple
collaborative examination of the
online using the following Web site: manufacturers are developing problem as it relates to various
https://www.surveymonkey.com/s/ therapeutic products that rely on a stakeholders and to identify potential
FDACompanionDiagnostics2015. FDA particular biomarker and that may solutions or paths to solutions for the
has verified the Web site addresses in require contemporaneous approval/ problem.
this document, but FDA is not clearance of a companion diagnostic if Dated: March 3, 2015.
responsible for any subsequent changes biomarker detection or measurement is Leslie Kux,
to the Web sites after this document necessary for the safe and effective use Associate Commissioner for Policy.
publishes in the Federal Register. Early of the therapeutic product. Therapeutic [FR Doc. 2015–05348 Filed 3–6–15; 8:45 am]
registration is recommended because product developers working in the same BILLING CODE 4164–01–P
audiocast connections are limited. target space can use different methods
Organizations are requested to register and measures for the biomarker, and
all participants but to view using one then partner with various sponsors to DEPARTMENT OF HEALTH AND
connection per location. After implement distinct companion HUMAN SERVICES
registration, participants will be sent diagnostics. These development
technical system requirements and programs can lead to approval/clearance National Institutes of Health
connection access information after of multiple therapeutic product-
March 19, 2015. companion diagnostic pairs for a single National Institute of Diabetes and
Comments: FDA is holding this public class of therapeutic products. For Digestive and Kidney Diseases; Notice
of Closed Meeting
mstockstill on DSK4VPTVN1PROD with NOTICES
workshop to obtain information on example, understanding of the
harmonization of companion Programmed Death Ligand 1 (PD–1) Pursuant to section 10(d) of the
diagnostics across a class of targeted checkpoint pathway underlies current Federal Advisory Committee Act, as
therapies. To permit the widest possible development of multiple targeted amended (5 U.S.C. App.), notice is
opportunity to obtain public comment, therapies and potential companion hereby given of the following meeting.
FDA is soliciting either electronic or diagnostics targeting and measuring PD– The meeting will be closed to the
written comments on all aspects of the 1 pathway biomarkers. Although the public in accordance with the
public workshop. The deadline for biomarker being detected/measured is provisions set forth in sections
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![12500 Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices
552b(c)(4) and 552b(c)(6), title 5 U.S.C., advisorycommittees/mchbadvisory/ DEPARTMENT OF HEALTH AND
as amended. The grant applications and InfantMortality/index.html. HUMAN SERVICES
the discussions could disclose Purpose: The Committee provides
confidential trade secrets or commercial Food and Drug Administration
advice and recommendations to the
property such as patentable material, Secretary of Health and Human Services [Docket No. FDA–2014–N–0913]
and personal information concerning on the following: Department of Health
individuals associated with the grant and Human Services’ programs that Agency Information Collection
applications, the disclosure of which focus on reducing infant mortality and Activities; Submission for Office of
would constitute a clearly unwarranted improving the health status of infants Management and Budget Review;
invasion of personal privacy. and pregnant women; and factors Comment Request; 513(g) Request for
Name of Committee: National Institute of affecting the continuum of care with Information
Diabetes and Digestive and Kidney Diseases respect to maternal and child health AGENCY: Food and Drug Administration,
Special Emphasis Panel, Ancillary Study on care. The Committee focuses on
IBD.
HHS.
outcomes following childbirth; ACTION: Notice.
Date: April 8, 2015.
Time: 4:30 p.m. to 6:00 p.m. strategies to coordinate myriad federal,
Agenda: To review and evaluate grant state, local, and private programs and SUMMARY: The Food and Drug
applications. efforts that are designed to deal with the Administration (FDA) is announcing
Place: National Institutes of Health, Two health and social problems impacting that a proposed collection of
Democracy Plaza, 6707 Democracy on infant mortality; and the information has been submitted to the
Boulevard, Bethesda, MD 20892, (Telephone implementation of the Healthy Start Office of Management and Budget
Conference Call). Program and Healthy People 2020 infant (OMB) for review and clearance under
Contact Person: Maria E. Davila-Bloom, the Paperwork Reduction Act of 1995.
mortality objectives.
Ph.D., Scientific Review Officer, Review
DATES: Fax written comments on the
Branch, DEA, NIDDK, National Institutes of Agenda: Topics that will be discussed
Health, Room 758, 6707 Democracy include the following: HRSA Update; collection of information by April 8,
Boulevard, Bethesda, MD 20892–5452, (301) MCHB Update; Healthy Start Program 2015.
594–7637, davila-bloomm@ Update; Updates from Partnering ADDRESSES: To ensure that comments on
extra.niddk.nih.gov. Agencies and Organizations; and, the information collection are received,
(Catalogue of Federal Domestic Assistance ACIM’s recommendations for the HHS OMB recommends that written
Program Nos. 93.847, Diabetes, National Strategy to Address Infant comments be faxed to the Office of
Endocrinology and Metabolic Research; Information and Regulatory Affairs,
93.848, Digestive Diseases and Nutrition Mortality, specifically Strategy 4:
Research; 93.849, Kidney Diseases, Urology Increase Health Equity and Reduce OMB, Attn: FDA Desk Officer, FAX:
and Hematology Research, National Institutes Disparities by Targeting Social 202–395–7285, or emailed to oira_
of Health, HHS) Determinants of Health through both submission@omb.eop.gov. All
Investments in High-Risk, Under- comments should be identified with the
Dated: March 3, 2015.
Resourced Communities and Major OMB control number 0910–0705. Also
David Clary, include the FDA docket number found
Initiatives to Address Poverty. Proposed
Program Analyst, Office of Federal Advisory in brackets in the heading of this
Committee Policy.
agenda items are subject to change as
priorities dictate. document.
[FR Doc. 2015–05311 Filed 3–6–15; 8:45 am]
Time will be provided for public FOR FURTHER INFORMATION CONTACT: FDA
BILLING CODE 4140–01–P
comments limited to 5 minutes each. PRA Staff, Office of Operations, Food
Comments are to be submitted in and Drug Administration, 8455
DEPARTMENT OF HEALTH AND writing no later than 5:00 p.m. (EST) on Colesville Rd., COLE–14526, Silver
HUMAN SERVICES March 19, 2015. Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Health Resources and Services SUPPLEMENTARY INFORMATION: In
Administration Anyone requiring information regarding
the Committee should contact Michael compliance with 44 U.S.C. 3507, FDA
C. Lu, M.D., M.P.H., Executive has submitted the following proposed
Advisory Committee on Infant collection of information to OMB for
Mortality; Notice of Meeting Secretary, ACIM, Health Resources and
Services Administration, Room 18 W, review and clearance.
In accordance with section 10(a)(2) of Parklawn Building, 5600 Fishers Lane, 513(g) Request for Information—(OMB
the Federal Advisory Committee Act Rockville, Maryland 20857, telephone: Control Number 0910–0705)—
(Pub. L. 92–463), notice is hereby given (301) 443–2170. (Extension)
of the following meeting:
Individuals who are submitting public Section 513(g) of the Federal Food,
Name: Advisory Committee on Infant
comments or who have questions Drug, and Cosmetic Act (the FD&C Act)
Mortality (ACIM).
regarding the meeting and location (21 U.S.C. 360c(g)) provides a means for
Dates and Times: should contact David S. de la Cruz, obtaining the Agency’s views about the
March 26, 2015, 8:30 a.m.–5:30 p.m. Ph.D., M.P.H., ACIM Designated Federal classification and regulatory
March 27, 2015, 8:30 a.m.–3:30 p.m. Official, HRSA, Maternal and Child requirements that may be applicable to
mstockstill on DSK4VPTVN1PROD with NOTICES
Place: Hyatt Regency Bethesda, One Health Bureau, telephone: (301) 443– a particular device. Section 513(g)
Bethesda Metro Center, 7400 Wisconsin 0543, or email: David.delaCruz@ provides that, within 60 days of the
Avenue, Bethesda, MD 20814. hrsa.hhs.gov. receipt of a written request of any
Status: The meeting is open to the person for information respecting the
Jackie Painter,
public with attendance limited to space class in which a device has been
availability. For more details and Director, Division of the Executive Secretariat. classified or the requirements applicable
registration, please visit the ACIM Web [FR Doc. 2015–05416 Filed 3–6–15; 8:45 am] to a device under the FD&C Act, the
site: http://www.hrsa.gov/ BILLING CODE 4165–15–P Secretary of Health and Human Services
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Document Created: 2015-12-18 12:05:45
Document Modified: 2015-12-18 12:05:45
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Dates | April 8, 2015. | |
| FR Citation | 80 FR 12499 |
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