Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Center for Devices and Radiological Health Appeals Processes, 22277-22278 [2016-08685]

Download as PDF Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Notices asabaliauskas on DSK3SPTVN1PROD with NOTICES an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA has approved for marketing the human biologic product CYRAMZA (ramucirumab). CYRAMZA is indicated for treatment of gastric cancer. Subsequent to this approval, the U.S. Patent and Trademark Office (USPTO) received a patent term restoration application for CYRAMZA (U.S. Patent No. 7,498,414) from Eli Lilly and Co., and the USPTO requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated March 19, 2015, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of CYRAMZA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product’s regulatory review period. II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for CYRAMZA is 3,521 days. Of this time, 3,279 days occurred during the testing phase of the regulatory review period, while 242 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: September 1, 2004. FDA has verified the applicant’s claim that the date the investigational new drug application (IND) became effective was on September 1, 2004. 2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): August 23, 2013. FDA has VerDate Sep<11>2014 17:27 Apr 14, 2016 Jkt 238001 verified the applicant’s claim that the biologics license application (BLA) for CYRAMZA (BLA 125477) was initially submitted on August 23, 2013. 3. The date the application was approved: April 21, 2014. FDA has verified the applicant’s claim that BLA 125477 was approved on April 21, 2014. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,059 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to http://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: April 11, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–08692 Filed 4–14–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0893] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Center for Devices and Radiological Health Appeals Processes AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing SUMMARY: PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 22277 that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by May 16, 2016. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0738. Also include the FDA docket number found in brackets in the heading of this document. 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: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Center for Devices and Radiological Health Appeals Processes— OMB Control Number 0910–0738— Extension The guidance document entitled ‘‘Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological Health Appeals Processes’’ describes the processes available to outside stakeholders to request additional review of decisions or actions by Center for Devices and Radiological Health (CDRH) employees. FDA is seeking approval for the new reporting burden associated with requests for additional review of decisions and actions by CDRH employees as described in the guidance. Individuals outside of FDA who disagree with a decision or action taken by CDRH and wish to have it reviewed or reconsidered have several processes for resolution from which to choose, including: Requests for supervisory review of an action; petitions; and hearings. Of these, by far the most commonly used is a request for supervisory review under § 10.75 (21 CFR 10.75) (a ‘‘10.75 appeal’’). Section 517A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360g–1), added by section 603 of the Food and Drug Safety and Innovation E:\FR\FM\15APN1.SGM 15APN1 22278 Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Notices Act of 2012, includes new requirements pertaining to the process and timelines for 10.75 appeals of ‘‘significant decisions’’ regarding 510(k) premarket notifications, applications for premarket approvals (PMAs), and applications for investigational device exemptions (IDEs). A request for review under § 10.75 should be based on the information that was already present in the administrative file at the time of the decision that is being reviewed as provided in § 10.75(d). New section 517A of the FD&C Act refers to significant decisions regarding the information in the administrative file for premarket notifications (section 510(k)); PMAs (section 515); and IDEs (section 520(g)) submissions is collected under existing regulations which specify the information manufacturers must submit so that FDA may properly evaluate the safety and effectiveness of medical devices. The information collections associated with these regulations are currently approved by the Office of Management and Budget as follows: The collections of information in 21 CFR part 807, subpart E (premarket notification) have been approved under OMB control number 0910–0120; the collections of information in 21 CFR part 814 (premarket approval) have been approved under OMB control number 0910–0231; and the collections of information in 21 CFR part 812 (investigational device exemption) have been approved under OMB control number 0910–0078. While CDRH already possesses in the administrative file the information that would form the basis of a decision on a matter under appeal, the submission of particular information regarding the request itself and the data and information relied on by the requestor in the appeal would facilitate timely resolution of the decision under review. The guidance describes the collection of information not expressly specified under existing regulations such as: The submission of the request for review, minor clarifications as part of the request, and supporting information. In the Federal Register of October 21, 2015 (80 FR 63804), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Activity Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours CDRH Appeals Processes Guidance Document ................ 50 1 50 8 400 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: April 8, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–08685 Filed 4–14–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0001] Antimicrobial Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. asabaliauskas on DSK3SPTVN1PROD with NOTICES ACTION: 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: Antimicrobial Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on June 9, 2016, from 8:30 a.m. to 5 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993–0002. VerDate Sep<11>2014 17:27 Apr 14, 2016 Jkt 238001 Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm408555.htm. Contact Person: Lauren D. Tesh, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301–796–9001, FAX: 301–847–8533, AMDAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at http:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: The committee will discuss biologics license application (BLA) 761046, bezlotoxumab (MK–6072) injection, submitted by Merck Sharpe & Dohme Corp., for the proposed PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 indication of prevention of Clostridium difficile infection recurrence. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at http://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before May 25, 2016. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before May 17, 2016. Time allotted for each E:\FR\FM\15APN1.SGM 15APN1

Agencies

[Federal Register Volume 81, Number 73 (Friday, April 15, 2016)]
[Notices]
[Pages 22277-22278]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08685]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0893]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Center for Devices 
and Radiological Health Appeals Processes

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 16, 
2016.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0738. 
Also include the FDA docket number found in brackets in the heading of 
this document.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Center for Devices and Radiological Health Appeals Processes--

OMB Control Number 0910-0738--Extension

    The guidance document entitled ``Guidance for Industry and Food and 
Drug Administration Staff; Center for Devices and Radiological Health 
Appeals Processes'' describes the processes available to outside 
stakeholders to request additional review of decisions or actions by 
Center for Devices and Radiological Health (CDRH) employees. FDA is 
seeking approval for the new reporting burden associated with requests 
for additional review of decisions and actions by CDRH employees as 
described in the guidance.
    Individuals outside of FDA who disagree with a decision or action 
taken by CDRH and wish to have it reviewed or reconsidered have several 
processes for resolution from which to choose, including: Requests for 
supervisory review of an action; petitions; and hearings. Of these, by 
far the most commonly used is a request for supervisory review under 
Sec.  10.75 (21 CFR 10.75) (a ``10.75 appeal''). Section 517A of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360g-1), 
added by section 603 of the Food and Drug Safety and Innovation

[[Page 22278]]

Act of 2012, includes new requirements pertaining to the process and 
timelines for 10.75 appeals of ``significant decisions'' regarding 
510(k) premarket notifications, applications for premarket approvals 
(PMAs), and applications for investigational device exemptions (IDEs).
    A request for review under Sec.  10.75 should be based on the 
information that was already present in the administrative file at the 
time of the decision that is being reviewed as provided in Sec.  
10.75(d). New section 517A of the FD&C Act refers to significant 
decisions regarding the information in the administrative file for 
premarket notifications (section 510(k)); PMAs (section 515); and IDEs 
(section 520(g)) submissions is collected under existing regulations 
which specify the information manufacturers must submit so that FDA may 
properly evaluate the safety and effectiveness of medical devices. The 
information collections associated with these regulations are currently 
approved by the Office of Management and Budget as follows: The 
collections of information in 21 CFR part 807, subpart E (premarket 
notification) have been approved under OMB control number 0910-0120; 
the collections of information in 21 CFR part 814 (premarket approval) 
have been approved under OMB control number 0910-0231; and the 
collections of information in 21 CFR part 812 (investigational device 
exemption) have been approved under OMB control number 0910-0078.
    While CDRH already possesses in the administrative file the 
information that would form the basis of a decision on a matter under 
appeal, the submission of particular information regarding the request 
itself and the data and information relied on by the requestor in the 
appeal would facilitate timely resolution of the decision under review. 
The guidance describes the collection of information not expressly 
specified under existing regulations such as: The submission of the 
request for review, minor clarifications as part of the request, and 
supporting information.
    In the Federal Register of October 21, 2015 (80 FR 63804), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                              Activity                                  Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH Appeals Processes Guidance Document...........................              50                1               50                8              400
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: April 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08685 Filed 4-14-16; 8:45 am]
 BILLING CODE 4164-01-P