80 FR 29721 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Substances Prohibited From Use in Animal Food or Feed
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 99 (May 22, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 99 (May 22, 2015)
| Page Range | 29721-29721 | |
| FR Document | 2015-12404 |
[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)] [Notices] [Page 29721] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-12404] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0510] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Substances Prohibited From Use in Animal Food or Feed AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: 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. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]. SUPPLEMENTARY INFORMATION: 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 http://www.reginfo.gov/public/do/PRAMain. 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
![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, FOR FURTHER INFORMATION CONTACT: FDA Management and Budget (OMB) under
under § 314.161, has determined that PRA Staff, Office of Operations, Food the Paperwork Reduction Act of 1995.
the drug product listed in this document and Drug Administration, 8455 FOR FURTHER INFORMATION CONTACT: FDA
was not withdrawn from sale for reasons Colesville Rd., COLE–14526, Silver PRA Staff, Office of Operations, Food
of safety or effectiveness. Accordingly, Spring, MD 20993–0002, PRAStaff@ and Drug Administration, 8455
the Agency will continue to list the drug fda.hhs.gov. Colesville Rd., COLE–14526, Silver
product listed in this document in the SUPPLEMENTARY INFORMATION: On March Spring, MD 20993–0002, PRAStaff@
‘‘Discontinued Drug Product List’’ 17, 2015, the Agency submitted a fda.hhs.gov.
section of the Orange Book. The proposed collection of information SUPPLEMENTARY INFORMATION: On March
‘‘Discontinued Drug Product List’’ entitled, ‘‘Substances Prohibited From 13, 2015, the Agency submitted a
identifies, among other items, drug Use in Animal Food or Feed’’ to OMB proposed collection of information
products that have been discontinued for review and clearance under 44 entitled, ‘‘Guidance for Industry:
from marketing for reasons other than U.S.C. 3507. An Agency may not Notification of a Health Claim or
safety or effectiveness. conduct or sponsor, and a person is not Nutrient Content Claim Based on an
Approved ANDAs that refer to the required to respond to, a collection of Authoritative Statement of a Scientific
NDA listed in this document are information unless it displays a Body’’ to OMB for review and clearance
unaffected by the discontinued currently valid OMB control number. under 44 U.S.C. 3507. An Agency may
marketing of the product subject to this OMB has now approved the information not conduct or sponsor, and a person is
NDA. Additional ANDAs that refer to collection and has assigned OMB not required to respond to, a collection
this product may also be approved by control number 0910–0627. The of information unless it displays a
the Agency if they comply with relevant approval expires on April 30, 2018. A currently valid OMB control number.
legal and regulatory requirements. If copy of the supporting statement for this OMB has now approved the information
FDA determines that labeling for information collection is available on collection and has assigned OMB
estradiol vaginal tablets should be the Internet at http://www.reginfo.gov/ control number 0910–0374. The
revised to meet current standards, the public/do/PRAMain. approval expires on April 30, 2018. A
Agency will advise ANDA applicants to
Dated: May 15, 2015. copy of the supporting statement for this
submit such labeling.
Leslie Kux, information collection is available on
Dated: May 18, 2015. the Internet at http://www.reginfo.gov/
Associate Commissioner for Policy.
Leslie Kux, public/do/PRAMain.
[FR Doc. 2015–12404 Filed 5–21–15; 8:45 am]
Associate Commissioner for Policy. Dated: May 15, 2015.
BILLING CODE 4164–01–P
[FR Doc. 2015–12396 Filed 5–21–15; 8:45 am] Leslie Kux,
BILLING CODE 4164–01–P Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND [FR Doc. 2015–12400 Filed 5–21–15; 8:45 am]
HUMAN SERVICES BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES Food and Drug Administration
Food and Drug Administration [Docket No. FDA–2011–N–0535] DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2011–N–0510] Agency Information Collection
Activities; Announcement of Office of Food and Drug Administration
Agency Information Collection Management and Budget Approval; [Docket No. FDA–2015–N–0001]
Activities; Announcement of Office of Guidance for Industry: Notification of a
Management and Budget Approval; Health Claim or Nutrient Content Claim Oncologic Drugs Advisory Committee;
Substances Prohibited From Use in Based on an Authoritative Statement Notice of Meeting
Animal Food or Feed of a Scientific Body
AGENCY: Food and Drug Administration,
AGENCY: Food and Drug Administration, AGENCY: Food and Drug Administration, HHS.
HHS. HHS. ACTION: Notice.
ACTION: Notice. ACTION: Notice.
This notice announces a forthcoming
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY: The Food and Drug SUMMARY: The Food and Drug meeting of a public advisory committee
Administration (FDA) is announcing Administration (FDA) is announcing of the Food and Drug Administration
that a collection of information entitled, that a collection of information entitled, (FDA). The meeting will be open to the
‘‘Substances Prohibited From Use in ‘‘Guidance for Industry: Notification of public.
Animal Food or Feed’’ has been a Health Claim or Nutrient Content Name of Committee: Oncologic Drugs
approved by the Office of Management Claim Based on an Authoritative Advisory Committee.
and Budget (OMB) under the Paperwork Statement of a Scientific Body’’ has General Function of the Committee:
Reduction Act of 1995. been approved by the Office of To provide advice and
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Document Created: 2015-12-15 15:45:42
Document Modified: 2015-12-15 15:45:42
| 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 | |
| Action | Notice. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 29721 |
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