80 FR 28278 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 95 (May 18, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 95 (May 18, 2015)
| Page Range | 28278-28279 | |
| FR Document | 2015-11853 |
[Federal Register Volume 80, Number 95 (Monday, May 18, 2015)] [Notices] [Pages 28278-28279] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-11853] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; 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 [[Page 28279]] 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 Allergy and Infectious Diseases Special Emphasis Panel; NIAID Peer Review Meeting. Date: June 9, 2015. Time: 10:30 a.m. to 5:00 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, Room 8F100, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call). Contact Person: Raymond R. Schleef, Ph.D., Senior Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institutes of Health/NIAID, 5601 Fishers Lane, MSC 9823, Rockville, MD 20892, 240-669-5019, [email protected]. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; NIAID Investigator Initiated Program Project (P01). Date: June 10, 2015. Time: 12:00 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Room 3F100, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call). Contact Person: Brenda Lange-Gustafson, Ph.D., Scientific Review Officer, NIAID/NIH/DHHS, Scientific Review Program, 5601 Fishers Lane, Room 3G13 Rockville, MD 20852, 240-669-5047, [email protected]. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; NIAID Investigator Initiated Program Project Applications (P01). Date: June 11, 2015. Time: 10:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Room 3G31B, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call). Contact Person: James T. Snyder, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institutes of Health/NIAID, 5601 Fishers Lane, MSC 9823, Room # 3G31B, Rockville, MD 20892, 240-669-5060, [email protected]. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: May 12, 2015. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015-11853 Filed 5-15-15; 8:45 am] BILLING CODE 4140-01-P
![28278 Federal Register / Vol. 80, No. 95 / Monday, May 18, 2015 / Notices
considerations for including patient 21 CFR 812.25(c) have been approved DEPARTMENT OF HEALTH AND
preference information in labeling for under OMB control number 0910–0078; HUMAN SERVICES
patients and health care professionals. the collections of information in 21 CFR
This draft guidance includes examples part 807 subpart E have been approved Food and Drug Administration
that illustrate how patient preference under OMB control number 0910–0120; [Docket No. FDA–2013–N–0545]
information may inform FDA’s the collections of information in 21 CFR
regulatory decisionmaking. The part 814 subparts B and E have been Agency Information Collection
guidance applies to both diagnostic and approved under OMB control number Activities; Announcement of Office of
therapeutic devices that are subject to 0910–0231; the collections of Management and Budget Approval;
these review processes. Additionally, information in 21 CFR part 814 subpart Infant Formula Requirements
this guidance may apply to other
H have been approved under OMB AGENCY: Food and Drug Administration,
stakeholders such as patient groups and
academia who may wish to conduct control number 0910–0332; and the HHS.
patient preference studies. collections of information in 21 CFR ACTION: Notice.
part 801 have been approved under
II. Significance of Guidance OMB control number 0910–0485. SUMMARY: The Food and Drug
This draft guidance is being issued Administration (FDA) is announcing
V. Comments that a collection of information entitled,
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115). ‘‘Infant Formula Requirements’’ has
Interested persons may submit either
The draft guidance, when finalized, will been approved by the Office of
electronic comments regarding this Management and Budget (OMB) under
represent the current thinking of FDA document to http://www.regulations.gov
on Patient Preference Information— the Paperwork Reduction Act of 1995.
or written comments to the Division of
Submission, Review in PMAs, HDE FOR FURTHER INFORMATION CONTACT: FDA
Dockets Management (see ADDRESSES). It PRA Staff, Office of Operations, Food
Applications, and De Novo Requests,
is only necessary to send one set of and Drug Administration, 8455
and Inclusion in Device Labeling. It
comments. Identify comments with the Colesville Rd., COLE–14526, Silver
does not establish any rights for any
docket number found in brackets in the Spring, MD 20993–0002, PRAStaff@
person and is not binding on FDA or the
public. You can use an alternative heading of this document. Received fda.hhs.gov.
approach if it satisfies the requirements comments may be seen in the Division
SUPPLEMENTARY INFORMATION: On March
of the applicable statutes and of Dockets Management between 9 a.m.
4, 2015, the Agency submitted a
regulations. and 4 p.m., Monday through Friday, and
proposed collection of information
will be posted to the docket at http:// entitled, ‘‘Infant Formula
III. Electronic Access www.regulations.gov. Requirements’’ to OMB for review and
Persons interested in obtaining a copy Specifically the Agency would like clearance under 44 U.S.C. 3507. An
of the draft guidance may do so by comments on the following questions: Agency may not conduct or sponsor,
downloading an electronic copy from and a person is not required to respond
the Internet. A search capability for all 1. Section IV of the draft guidance
recommends qualities for patient to, a collection of information unless it
Center for Devices and Radiological displays a currently valid OMB control
Health guidance documents is available preference studies. Do you believe these
recommended qualities are clear and number. OMB has now approved the
at http://www.fda.gov/MedicalDevices/ information collection and has assigned
DeviceRegulationandGuidance/ understandable? If not, what should be
OMB control number 0910–0256. The
GuidanceDocuments/default.htm. reworded or edited? Is there anything
approval expires on April 30, 2018. A
Guidance documents are also available missing? If so, what needs to be added?
copy of the supporting statement for this
at http://www.regulations.gov or from 2. Under what conditions should information collection is available on
CBER at http://www.fda.gov/ health care professional or patient the Internet at http://www.reginfo.gov/
BiologicsBloodVaccines/ labeling include information about public/do/PRAMain.
GuidanceCompliance patient preference studies?
RegulatoryInformation/default.htm. Dated: May 12, 2015.
Persons unable to download an 3. How should sponsors present Leslie Kux,
electronic copy of ‘‘Patient Preference patient preference information in the Associate Commissioner for Policy.
Information—Submission, Review in health care professional and patient [FR Doc. 2015–11821 Filed 5–15–15; 8:45 am]
PMAs, HDE Applications, and De Novo labeling? BILLING CODE 4164–01–P
Requests, and Inclusion in Device 4. How should labeling indicate that
Labeling’’ may send an email request to only a subset of patients in a patient
CDRH-Guidance@fda.hhs.gov to receive preference study were willing to accept DEPARTMENT OF HEALTH AND
an electronic copy of the document. certain risks in order to achieve HUMAN SERVICES
Please use the document number probable benefits?
1500006 to identify the guidance you National Institutes of Health
are requesting. 5. How should sponsors and the FDA
ensure that patients receive and National Institute of Allergy and
IV. Paperwork Reduction Act of 1995 understand patient preference Infectious Diseases; Notice of Closed
asabaliauskas on DSK5VPTVN1PROD with NOTICES
This guidance refers to currently information? Meetings.
approved collections of information Dated: May 12, 2015. Pursuant to section 10(d) of the
found in FDA regulations. These Federal Advisory Committee Act, as
Leslie Kux,
collections of information are subject to amended (5 U.S.C. App.), notice is
review by the Office of Management and Associate Commissioner for Policy.
hereby given of the following meetings.
Budget (OMB) under the Paperwork [FR Doc. 2015–11819 Filed 5–15–15; 8:45 am] The meetings will be closed to the
Reduction Act of 1995 (44 U.S.C. 3501– BILLING CODE 4164–01–P public in accordance with the
3520). The collections of information in provisions set forth in sections
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![Federal Register / Vol. 80, No. 95 / Monday, May 18, 2015 / Notices 28279
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., DEPARTMENT OF HEALTH AND Wisconsin Avenue, Bethesda, MD 20814
as amended. The grant applications and HUMAN SERVICES which was published in the Federal
the discussions could disclose Register on April 22, 2015, 80FR22540.
confidential trade secrets or commercial National Institutes of Health The meeting notice is amended to
property such as patentable material, change the title from Exploratory/
and personal information concerning National Institute of Allergy and Development Research Grant Program
individuals associated with the grant Infectious Diseases; Notice of Closed Omnibus SEP–6 to NCI Omnibus R03 &
applications, the disclosure of which Meeting R21 SEP–6. The meeting is closed to the
would constitute a clearly unwarranted Pursuant to section 10(d) of the public.
invasion of personal privacy. Federal Advisory Committee Act, as Dated: May 12, 2015.
Name of Committee: National Institute of amended (5 U.S.C. App.), notice is Melanie J. Gray,
Allergy and Infectious Diseases Special hereby given of the following meeting. Program Analyst, Office of Federal Advisory
Emphasis Panel; NIAID Peer Review Meeting. The meeting will be closed to the Committee Policy.
Date: June 9, 2015. public in accordance with the
Time: 10:30 a.m. to 5:00 p.m. [FR Doc. 2015–11823 Filed 5–15–15; 8:45 am]
Agenda: To review and evaluate contract
provisions set forth in sections BILLING CODE 4140–01–P
proposals. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Place: National Institutes of Health, Room as amended. The grant applications and
8F100, 5601 Fishers Lane, Rockville, MD the discussions could disclose DEPARTMENT OF HEALTH AND
20892 (Telephone Conference Call). confidential trade secrets or commercial HUMAN SERVICES
Contact Person: Raymond R. Schleef, property such as patentable material,
Ph.D., Senior Scientific Review Officer, and personal information concerning National Institutes of Health
Scientific Review Program, Division of
individuals associated with the grant
Extramural Activities, National Institutes of National Cancer Institute; Amended
Health/NIAID, 5601 Fishers Lane, MSC 9823, applications, the disclosure of which
would constitute a clearly unwarranted Notice of Meeting
Rockville, MD 20892, 240–669–5019,
schleefrr@niaid.nih.gov. invasion of personal privacy. Notice is hereby given of a change in
Name of Committee: National Institute of Name of Committee: Microbiology, the meeting of the National Cancer
Allergy and Infectious Diseases Special Infectious Diseases and AIDS Initial Review Institute Special Emphasis Panel, June
Emphasis Panel; NIAID Investigator Initiated Group, Microbiology and Infectious Diseases 29, 2015, 8:00 a.m. to June 30, 2015,
Program Project (P01). Research Committee. 05:00 p.m., Hyatt Regency Bethesda,
Date: June 10, 2015. Date: June 11–12, 2015.
Time: 12:00 p.m. to 3:30 p.m. One Bethesda Metro Center, 7400
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant Agenda: To review and evaluate grant Wisconsin Avenue, Bethesda, MD 20814
applications. applications. which was published in the Federal
Place: National Institutes of Health, Room Place: National Institutes of Health, 5601 Register on April 22, 2015, 80 FR 22540.
3F100, 5601 Fishers Lane, Rockville, MD Fishers Lane, Rockville, MD 20892, The meeting notice is amended to
20892 (Telephone Conference Call). (Telephone Conference Call). change the title from Exploratory/
Contact Person: Brenda Lange-Gustafson, Contact Person: Frank S. De Silva, Ph.D., Development Research Grant Program
Ph.D., Scientific Review Officer, NIAID/NIH/ Scientific Review Officer, Scientific Review Omnibus SEP–3 to NCI Omnibus R03 &
DHHS, Scientific Review Program, 5601 Program, Division of Extramural Activities,
Fishers Lane, Room 3G13 Rockville, MD R21 SEP–3. The meeting is closed to the
National Institutes of Health/NIAID 5601
20852, 240–669–5047, bgustafson@ public.
Fishers Lane MSC 9823, Rockville, MD
niaid.nih.gov. 20892–9823, 240–669–5023, fdesilva@ Dated: May 12, 2015.
Name of Committee: National Institute of niaid.nih.gov. Melanie J. Gray,
Allergy and Infectious Diseases Special (Catalogue of Federal Domestic Assistance Program Analyst, Office of Federal Advisory
Emphasis Panel; NIAID Investigator Initiated Program Nos. 93.855, Allergy, Immunology, Committee Policy.
Program Project Applications (P01). and Transplantation Research; 93.856,
Date: June 11, 2015. [FR Doc. 2015–11824 Filed 5–15–15; 8:45 am]
Microbiology and Infectious Diseases
Time: 10:00 a.m. to 6:00 p.m. Research, National Institutes of Health, HHS) BILLING CODE 4140–01–P
Agenda: To review and evaluate grant
applications. Dated: May 12, 2015.
Place: National Institutes of Health, Room David Clary, DEPARTMENT OF HEALTH AND
3G31B, 5601 Fishers Lane, Rockville, MD Program Analyst, Office of Federal Advisory HUMAN SERVICES
20892 (Telephone Conference Call). Committee Policy.
Contact Person: James T. Snyder, Ph.D., National Institutes of Health
[FR Doc. 2015–11852 Filed 5–15–15; 8:45 am]
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities, BILLING CODE 4140–01–P
National Institute of Allergy and
National Institutes of Health/NIAID, 5601 Infectious Diseases; Notice of Closed
Fishers Lane, MSC 9823, Room # 3G31B,
DEPARTMENT OF HEALTH AND Meeting
Rockville, MD 20892, 240–669–5060,
james.snyder@nih.gov. HUMAN SERVICES Pursuant to section 10(d) of the
(Catalogue of Federal Domestic Assistance Federal Advisory Committee Act, as
Program Nos. 93.855, Allergy, Immunology, National Institutes of Health amended (5 U.S.C. App.), notice is
and Transplantation Research; 93.856, hereby given of a meeting of the
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Microbiology and Infectious Diseases National Cancer Institute Amended
Research, National Institutes of Health, HHS) Notice of Meeting Division of Intramural Research Board
of Scientific Counselors, NIAID.
Dated: May 12, 2015. Notice is hereby given of a change in The meeting will be closed to the
David Clary, the meeting of the National Cancer public as indicated below in accordance
Program Analyst, Office of Federal Advisory Institute Special Emphasis Panel, June with the provisions set forth in section
Committee Policy. 09, 2015, 4:30 p.m. to June 10, 2015, 552b(c)(6), Title 5 U.S.C., as amended
[FR Doc. 2015–11853 Filed 5–15–15; 8:45 am] 06:00 p.m., Doubletree Hotel Bethesda, for the review, discussion, and
BILLING CODE 4140–01–P (Formally Holiday Inn Select), 8120 evaluation of individual grant
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Document Created: 2015-12-16 07:38:47
Document Modified: 2015-12-16 07:38:47
| 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 | June 9, 2015. | |
| FR Citation | 80 FR 28278 |
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