81_FR_86196 81 FR 85967 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Abbreviated New Drug Applications and 505(b)(2) Applications

81 FR 85967 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Abbreviated New Drug Applications and 505(b)(2) Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 229 (November 29, 2016)

Page Range85967-85967
FR Document2016-28655

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Abbreviated New Drug Applications and 505(b)(2) Applications'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Federal Register, Volume 81 Issue 229 (Tuesday, November 29, 2016) 
[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)]
[Notices]
[Page 85967]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-28655]



[[Page 85967]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0830]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Abbreviated New Drug Applications 
and 505(b)(2) Applications

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 ``Abbreviated New Drug Applications 
and 505(b)(2) Applications'' 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, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, [email protected].

SUPPLEMENTARY INFORMATION: On October 6, 2016, the Agency submitted a 
proposed collection of information entitled ``Abbreviated New Drug 
Applications and 505(b)(2) Applications'' 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 
0910-0786. The approval expires on November 30, 2019. A copy of the 
supporting statement for this information collection is available on 
the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: November 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28655 Filed 11-28-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices 85967 DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND such as medical information, your or HUMAN SERVICES HUMAN SERVICES anyone else’s Social Security number, or confidential business information, such Food and Drug Administration Food and Drug Administration as a manufacturing process. Please note [Docket No. FDA–2014–D–2153] that if you include your name, contact [Docket No. FDA–2011–N–0830] information, or other information that Mitigating the Risk of Cross- identifies you in the body of your Agency Information Collection Contamination From Valves and comments, that information will be Activities; Announcement of Office of Accessories Used for Irrigation posted on http://www.regulations.gov. Management and Budget Approval; Through Flexible Gastrointestinal • If you want to submit a comment Abbreviated New Drug Applications Endoscopes; Guidance for Industry with confidential information that you and Food and Drug Administration do not wish to be made available to the and 505(b)(2) Applications Staff; Availability public, submit the comment as a AGENCY: Food and Drug Administration, written/paper submission and in the AGENCY: Food and Drug Administration, manner detailed (see ‘‘Written/Paper HHS. HHS. Submissions’’ and ‘‘Instructions’’). ACTION: Notice. ACTION: Notice of availability. Written/Paper Submissions SUMMARY: The Food and Drug SUMMARY: The Food and Drug Submit written/paper submissions as Administration (FDA) is announcing Administration (FDA or Agency) is follows: announcing the availability of the • Mail/Hand delivery/Courier (for that a collection of information entitled guidance entitled ‘‘Mitigating the Risk written/paper submissions): Division of ‘‘Abbreviated New Drug Applications Dockets Management (HFA–305), Food and 505(b)(2) Applications’’ has been of Cross-Contamination From Valves and Accessories Used for Irrigation and Drug Administration, 5630 Fishers approved by the Office of Management Lane, Rm. 1061, Rockville, MD 20852. Through Flexible Gastrointestinal and Budget (OMB) under the Paperwork Endoscopes.’’ Flexible gastrointestinal • For written/paper comments Reduction Act of 1995. submitted to the Division of Dockets endoscopes and accessories are class II FOR FURTHER INFORMATION CONTACT: FDA devices and identified with product Management, FDA will post your PRA Staff, Office of Operations, Food codes such as FDF, FDS, and OCX. comment, as well as any attachments, and Drug Administration, Three White When using these devices during an except for information submitted, entire day of procedures (e.g., marked and identified, as confidential, Flint North, 10A–12M, 11601 colonoscopies), clinicians typically use if submitted as detailed in Landsdown St., North Bethesda, MD one irrigation system (i.e., one water ‘‘Instructions.’’ 20852, PRAStaff@fda.hhs.gov. Instructions: All submissions received bottle, one set of tubing and valves, etc.) SUPPLEMENTARY INFORMATION: On without cleaning and sterilizing all the must include the Docket No. FDA– October 6, 2016, the Agency submitted system components between patients. 2014–D–2153 for ‘‘Mitigating the Risk of a proposed collection of information This guidance highlights the cross- Cross-Contamination From Valves and entitled ‘‘Abbreviated New Drug contamination risk associated with day- Accessories Used for Irrigation Through Applications and 505(b)(2) use of irrigation systems used with Flexible Gastrointestinal Endoscopes.’’ Applications’’ to OMB for review and flexible gastrointestinal endoscopes; Received comments will be placed in clearance under 44 U.S.C. 3507. An clarifies terminology used to describe the docket and, except for those Agency may not conduct or sponsor, these devices; and outlines strategies to submitted as ‘‘Confidential mitigate the risk of cross-contamination Submissions,’’ publicly viewable at and a person is not required to respond between patients during these http://www.regulations.gov or at the to, a collection of information unless it procedures. Division of Dockets Management displays a currently valid OMB control between 9 a.m. and 4 p.m., Monday number. OMB has now approved the DATES: Submit either electronic or through Friday. information collection and has assigned written comments on this guidance at • Confidential Submissions—To OMB control number 0910–0786. The any time. General comments on Agency submit a comment with confidential approval expires on November 30, 2019. guidance documents are welcome at any information that you do not wish to be A copy of the supporting statement for time. made publicly available, submit your this information collection is available ADDRESSES: You may submit comments comments only as a written/paper on the Internet at http:// as follows: submission. You should submit two www.reginfo.gov/public/do/PRAMain. copies total. One copy will include the Electronic Submissions information you claim to be confidential Dated: November 22, 2016. Submit electronic comments in the with a heading or cover note that states Leslie Kux, following way: ‘‘THIS DOCUMENT CONTAINS Associate Commissioner for Policy. • Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION.’’ The [FR Doc. 2016–28655 Filed 11–28–16; 8:45 am] www.regulations.gov. Follow the Agency will review this copy, including BILLING CODE 4164–01–P instructions for submitting comments. the claimed confidential information, in Comments submitted electronically, its consideration of comments. The asabaliauskas on DSK3SPTVN1PROD with NOTICES including attachments, to http:// second copy, which will have the www.regulations.gov will be posted to claimed confidential information the docket unchanged. Because your redacted/blacked out, will be available comment will be made public, you are for public viewing and posted on http:// solely responsible for ensuring that your www.regulations.gov. Submit both comment does not include any copies to the Division of Dockets confidential information that you or a Management. If you do not wish your third party may not wish to be posted, name and contact information to be VerDate Sep<11>2014 17:48 Nov 28, 2016 Jkt 241001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1


Document Created: 2016-11-29 00:33:10
Document Modified: 2016-11-29 00:33:10
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, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]
FR Citation81 FR 85967 
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