Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body, 29721 [2015-12400]

Download as PDF Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices 29721 FDA has become aware that the drug product listed in the table in this document is no longer being marketed. Application No. Drug Applicant NDA 020908 ....... VAGIFEM (estradiol) Vaginal Tablets, 25 micrograms ........... Novo Nordisk Inc., 800 Scudders Mill Rd., Plainsboro, NJ 08536. FDA has reviewed its records and, under § 314.161, has determined that the drug product listed in this document was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug product listed in this document in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. Approved ANDAs that refer to the NDA listed in this document are unaffected by the discontinued marketing of the product subject to this NDA. Additional ANDAs that refer to this product may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for estradiol vaginal tablets should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: May 18, 2015. Leslie Kux, Associate Commissioner for Policy. FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: On March 17, 2015, the Agency submitted a proposed collection of information entitled, ‘‘Substances Prohibited From Use in Animal Food or Feed’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0627. The approval expires on April 30, 2018. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. SUPPLEMENTARY INFORMATION: Dated: May 15, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–12404 Filed 5–21–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2011–N–0510] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Substances Prohibited From Use in Animal Food or Feed Food and Drug Administration, asabaliauskas on DSK5VPTVN1PROD with NOTICES HHS. AGENCY: Food and Drug Administration, HHS. Notice. ACTION: The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ‘‘Substances Prohibited From Use in Animal Food or Feed’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: VerDate Sep<11>2014 18:19 May 21, 2015 Jkt 235001 BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2011–N–0535] ACTION: [FR Doc. 2015–12400 Filed 5–21–15; 8:45 am] Food and Drug Administration Food and Drug Administration AGENCY: On March 13, 2015, the Agency submitted a proposed collection of information entitled, ‘‘Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0374. The approval expires on April 30, 2018. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. SUPPLEMENTARY INFORMATION: Dated: May 15, 2015. Leslie Kux, Associate Commissioner for Policy. BILLING CODE 4164–01–P [FR Doc. 2015–12396 Filed 5–21–15; 8:45 am] Management and Budget (OMB) under the Paperwork Reduction Act of 1995. 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. [Docket No. FDA–2015–N–0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ‘‘Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body’’ has been approved by the Office of Frm 00120 Fmt 4703 Sfmt 4703 Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: PO 00000 Food and Drug Administration Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Oncologic Drugs Advisory Committee. General Function of the Committee: To provide advice and E:\FR\FM\22MYN1.SGM 22MYN1

Agencies

[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)]
[Notices]
[Page 29721]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12400]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0535]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Guidance for Industry: Notification 
of a Health Claim or Nutrient Content Claim Based on an Authoritative 
Statement of a Scientific Body

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled, ``Guidance for Industry: 
Notification of a Health Claim or Nutrient Content Claim Based on an 
Authoritative Statement of a Scientific Body'' has been approved by the 
Office of Management and Budget (OMB) under the Paperwork Reduction Act 
of 1995.

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: On March 13, 2015, the Agency submitted a 
proposed collection of information entitled, ``Guidance for Industry: 
Notification of a Health Claim or Nutrient Content Claim Based on an 
Authoritative Statement of a Scientific Body'' to OMB for review and 
clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, 
and a person is not required to respond to, a collection of information 
unless it displays a currently valid OMB control number. OMB has now 
approved the information collection and has assigned OMB control number 
0910-0374. The approval expires on April 30, 2018. A copy of the 
supporting statement for this information collection is available on 
the Internet at https://www.reginfo.gov/public/do/PRAMain.

    Dated: May 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12400 Filed 5-21-15; 8:45 am]
BILLING CODE 4164-01-P
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