81_FR_7577 81 FR 7548 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution

81 FR 7548 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 29 (February 12, 2016)

Page Range7548-7548
FR Document2016-02881

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Federal Register, Volume 81 Issue 29 (Friday, February 12, 2016) 
[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Notices]
[Page 7548]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-02881]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0742]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Registration of Producers of Drugs 
and Listing of Drugs in Commercial Distribution

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Registration of Producers of Drugs 
and Listing of Drugs in Commercial Distribution'' 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 July 8, 2015, the Agency submitted a 
proposed collection of information entitled ``Registration of Producers 
of Drugs and Listing of Drugs in Commercial Distribution'' 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 0910-0045. The approval expires on December 31, 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: February 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02881 Filed 2-11-16; 8:45 am]
 BILLING CODE 4164-01-P

7548 Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Notices currently available. CD6 is a potent contact William Ronnenberg (see FOR DEPARTMENT OF HEALTH AND monoclonal antibody against N1 FURTHER INFORMATION CONTACT). HUMAN SERVICES subtypes of NA that inhibits the Dated: February 4, 2016. enzymatic activity of the NA protein, Food and Drug Administration Leslie Kux, including NA variants resistant to NA [Docket No. FDA–2016–N–0001] Associate Commissioner for Policy. inhibitors. In a murine model of [FR Doc. 2016–02887 Filed 2–11–16; 8:45 am] infection, a single dose of antibody was Annual Computational Science protective against lethal challenge with BILLING CODE 4164–01–P Symposium; Conference H1N1 influenza virus. The CD6 antibody can potentially be used in AGENCY: Food and Drug Administration, DEPARTMENT OF HEALTH AND HHS. combination with other antibodies in an HUMAN SERVICES ACTION: Notice of public conference. antibody ‘‘cocktail’’ or in conjunction with other therapeutic agents. Food and Drug Administration Additionally, this unique anti-NA SUMMARY: The Food and Drug antibody may be useful in combination Administration, in cosponsorship with with known neutralizing anti- [Docket No. FDA–2011–N–0742] the Pharmaceutical Users Software hemagglutinin (HA) antibodies. Exchange (PhUSE) is announcing a Agency Information Collection public conference entitled ‘‘The FDA/ Potential Commercial Applications Activities; Announcement of Office of PhUSE Annual Computational Science Management and Budget Approval; Symposium.’’ The purpose of the • Prophylactic and therapeutic Registration of Producers of Drugs conference is to help the broader against influenza virus infections; • Diagnostic tests for influenza virus and Listing of Drugs in Commercial community align and share experiences infections; and Distribution to advance computational science. At • Reagent to measure the potency of AGENCY: Food and Drug Administration, the conference, which will bring H1N1 NA in influenza virus vaccines. together FDA, industry, and academia, HHS. FDA will update participants on current Competitive Advantages ACTION: Notice. initiatives, and collaborative project • Monoclonal antibody demonstrated groups will address specific challenges to be effective against circulating H1N1 SUMMARY: The Food and Drug in accessing and reviewing data to influenza viruses; Administration (FDA) is announcing support product development. These • Monoclonal antibody binds a novel, that a collection of information entitled project groups will focus on solutions conserved epitope spanning NA dimers; ‘‘Registration of Producers of Drugs and and practical ways to implement them. and Listing of Drugs in Commercial DATES: The meeting will be held on • Monoclonal antibody is well-suited Distribution’’ has been approved by the March 13, 2016, from 3 p.m. to 7 p.m., for an antibody cocktail that includes Office of Management and Budget and March 14 to 15, 2016, from 9 a.m. anti-HA antibodies. (OMB) under the Paperwork Reduction to 5:30 p.m. Development Stage: Early state; In Act of 1995. ADDRESSES: The meeting will be held at vitro data available; In vivo data FOR FURTHER INFORMATION CONTACT: FDA the Silver Spring Civic Building at available (animal). PRA Staff, Office of Operations, Food Inventors: Hongquan Wan (FDA); Veterans Plaza, One Veterans Pl., Silver and Drug Administration, 8455 Spring, MD 20910, 1–240–777–5300. Maryna Eichelberger (FDA); Hua Yang Colesville Rd., COLE–14526, Silver FOR FURTHER INFORMATION CONTACT: (CDC); James Stevens (CDC); David Spring, MD 20993–0002, PRAStaff@ Chris Decker, PhUSE FDA Liaison Shore (CDC); and Rebecca Garten (CDC). fda.hhs.gov. Director, Pharmaceutical Users Software Publication: Wan, H., H. Yang, D. A. Shore, R. J. Garten, L. Couzens, J. Gao, SUPPLEMENTARY INFORMATION: On July 8, Exchange (PhUSE), Kent Innovation L. Jiang, P. J. Carney, J. Villanueva, J. 2015, the Agency submitted a proposed Centre, Broadstairs, Kent CT10 2QQ, Stevens, and M. C. Eichelberger. collection of information entitled United Kingdom; 1–609–514–5105 (US), ‘‘Structural Characterization of a ‘‘Registration of Producers of Drugs and css@phuse.eu. Protective Epitope Spanning Listing of Drugs in Commercial SUPPLEMENTARY INFORMATION: A(H1N1)pdm09 Influenza Virus Distribution’’ to OMB for review and I. Background Neuraminidase Monomers.’’ 6:6114, clearance under 44 U.S.C. 3507. An Nature Communications, 2015. Agency may not conduct or sponsor, Since 2008, the Office of Intellectual Property: HHS Reference and a person is not required to respond Computational Science (formerly the No. E–005–2015/0—U.S. Provisional to, a collection of information unless it Computational Science Center) of FDA’s Patent Application No. 62/088,388 filed displays a currently valid OMB control Center for Drug Evaluation and Research December 5, 2014. number. OMB has now approved the (CDER) has supported CDER’s scientific Licensing and Collaborative Research information collection and has assigned community by offering innovative Opportunity: The invention is owned by OMB control number 0910–0045. The solutions that improve the scientific an Agency of the U.S. Government and approval expires on December 31, 2018. drug review process by integrating data, is available for licensing in accordance A copy of the supporting statement for tools, services, and training. Since the asabaliauskas on DSK9F6TC42PROD with NOTICES2 with 35 U.S.C. 209 and 37 CFR part 404. this information collection is available first Computational Science Symposium The Food and Drug Administration is on the Internet at http:// four years ago, FDA has played an seeking statements of capability or www.reginfo.gov/public/do/PRAMain. important part in the development and interest from parties interested in ongoing support of the conference and collaborative research to further Dated: February 8, 2016. the associated PhUSE Computational develop, evaluate, or commercialize this Leslie Kux, Science Working Groups. The PhUSE technology. Parties interested in Associate Commissioner for Policy. Collaboration was formed to bring licensing or collaborative research [FR Doc. 2016–02881 Filed 2–11–16; 8:45 am] together experts from industry, FDA and activities for this technology should BILLING CODE 4164–01–P other regulatory agencies, academia, and VerDate Sep<11>2014 17:38 Feb 11, 2016 Jkt 238001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\12FEN1.SGM 12FEN1


Document Created: 2016-02-12 01:23:47
Document Modified: 2016-02-12 01:23:47
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
ActionNotice.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation81 FR 7548 
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