81 FR 22277 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Center for Devices and Radiological Health Appeals Processes
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 73 (April 15, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 73 (April 15, 2016)
| Page Range | 22277-22278 | |
| FR Document | 2016-08685 |
[Federal Register Volume 81, Number 73 (Friday, April 15, 2016)] [Notices] [Pages 22277-22278] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-08685] ----------------------------------------------------------------------- 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 [email protected]. 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, [email protected]. 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
![Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Notices 22277
an approval phase. For human verified the applicant’s claim that the that a proposed collection of
biological products, the testing phase biologics license application (BLA) for information has been submitted to the
begins when the exemption to permit CYRAMZA (BLA 125477) was initially Office of Management and Budget
the clinical investigations of the submitted on August 23, 2013. (OMB) for review and clearance under
biological becomes effective and runs 3. The date the application was the Paperwork Reduction Act of 1995.
until the approval phase begins. The approved: April 21, 2014. FDA has DATES: Fax written comments on the
approval phase starts with the initial verified the applicant’s claim that BLA collection of information by May 16,
submission of an application to market 125477 was approved on April 21, 2014. 2016.
the human biological product and This determination of the regulatory
ADDRESSES: To ensure that comments on
continues until FDA grants permission review period establishes the maximum
potential length of a patent extension. the information collection are received,
to market the biological product.
However, the USPTO applies several OMB recommends that written
Although only a portion of a regulatory
statutory limitations in its calculations comments be faxed to the Office of
review period may count toward the
of the actual period for patent extension. Information and Regulatory Affairs,
actual amount of extension that the
In its application for patent extension, OMB, Attn: FDA Desk Officer, FAX:
Director of USPTO may award (for
this applicant seeks 1,059 days of patent 202–395–7285, or emailed to
example, half the testing phase must be
term extension. oira_submission@omb.eop.gov. All
subtracted as well as any time that may
comments should be identified with the
have occurred before the patent was III. Petitions OMB control number 0910–0738. Also
issued), FDA’s determination of the
Anyone with knowledge that any of include the FDA docket number found
length of a regulatory review period for
a human biological product will include the dates as published are incorrect may in brackets in the heading of this
all of the testing phase and approval submit either electronic or written document.
phase as specified in 35 U.S.C. comments and ask for a redetermination FOR FURTHER INFORMATION CONTACT: FDA
156(g)(1)(B). (see DATES). Furthermore, any interested PRA Staff, Office of Operations, Food
FDA has approved for marketing the person may petition FDA for a and Drug Administration, 8455
human biologic product CYRAMZA determination regarding whether the Colesville Rd., COLE–14526, Silver
(ramucirumab). CYRAMZA is indicated applicant for extension acted with due Spring, MD 20993–0002,
for treatment of gastric cancer. diligence during the regulatory review PRAStaff@fda.hhs.gov.
Subsequent to this approval, the U.S. period. To meet its burden, the petition SUPPLEMENTARY INFORMATION: In
Patent and Trademark Office (USPTO) must be timely (see DATES) and contain compliance with 44 U.S.C. 3507, FDA
received a patent term restoration sufficient facts to merit an FDA has submitted the following proposed
application for CYRAMZA (U.S. Patent investigation. (See H. Rept. 857, part 1, collection of information to OMB for
No. 7,498,414) from Eli Lilly and Co., 98th Cong., 2d sess., pp. 41–42, 1984.) review and clearance.
and the USPTO requested FDA’s Petitions should be in the format
assistance in determining this patent’s specified in 21 CFR 10.30. Center for Devices and Radiological
eligibility for patent term restoration. In Submit petitions electronically to Health Appeals Processes—
a letter dated March 19, 2015, FDA http://www.regulations.gov at Docket
OMB Control Number 0910–0738—
advised the USPTO that this human No. FDA–2013–S–0610. Submit written
Extension
biological product had undergone a petitions (two copies are required) to the
regulatory review period and that the Division of Dockets Management (HFA– The guidance document entitled
approval of CYRAMZA represented the 305), Food and Drug Administration, ‘‘Guidance for Industry and Food and
first permitted commercial marketing or 5630 Fishers Lane, Rm. 1061, Rockville, Drug Administration Staff; Center for
use of the product. Thereafter, the MD 20852. Devices and Radiological Health
USPTO requested that FDA determine Appeals Processes’’ describes the
Dated: April 11, 2016.
the product’s regulatory review period. processes available to outside
Leslie Kux,
stakeholders to request additional
II. Determination of Regulatory Review Associate Commissioner for Policy. review of decisions or actions by Center
Period [FR Doc. 2016–08692 Filed 4–14–16; 8:45 am] for Devices and Radiological Health
FDA has determined that the BILLING CODE 4164–01–P (CDRH) employees. FDA is seeking
applicable regulatory review period for approval for the new reporting burden
CYRAMZA is 3,521 days. Of this time, associated with requests for additional
3,279 days occurred during the testing DEPARTMENT OF HEALTH AND review of decisions and actions by
phase of the regulatory review period, HUMAN SERVICES CDRH employees as described in the
while 242 days occurred during the Food and Drug Administration guidance.
approval phase. These periods of time Individuals outside of FDA who
were derived from the following dates: [Docket No. FDA–2011–D–0893] disagree with a decision or action taken
1. The date an exemption under by CDRH and wish to have it reviewed
section 505(i) of the Federal Food, Drug, Agency Information Collection or reconsidered have several processes
and Cosmetic Act (21 U.S.C. 355(i)) Activities; Submission for Office of for resolution from which to choose,
became effective: September 1, 2004. Management and Budget Review; including: Requests for supervisory
FDA has verified the applicant’s claim Comment Request; Center for Devices review of an action; petitions; and
asabaliauskas on DSK3SPTVN1PROD with NOTICES
that the date the investigational new and Radiological Health Appeals hearings. Of these, by far the most
drug application (IND) became effective Processes commonly used is a request for
was on September 1, 2004. AGENCY: Food and Drug Administration, supervisory review under § 10.75 (21
2. The date the application was HHS. CFR 10.75) (a ‘‘10.75 appeal’’). Section
initially submitted with respect to the ACTION: Notice. 517A of the Federal Food, Drug, and
human biological product under section Cosmetic Act (the FD&C Act) (21 U.S.C.
351 of the Public Health Service Act (42 SUMMARY: The Food and Drug 360g–1), added by section 603 of the
U.S.C. 262): August 23, 2013. FDA has Administration (FDA) is announcing Food and Drug Safety and Innovation
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![22278 Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Notices
Act of 2012, includes new requirements information manufacturers must submit would form the basis of a decision on
pertaining to the process and timelines so that FDA may properly evaluate the a matter under appeal, the submission
for 10.75 appeals of ‘‘significant safety and effectiveness of medical of particular information regarding the
decisions’’ regarding 510(k) premarket devices. The information collections request itself and the data and
notifications, applications for premarket associated with these regulations are information relied on by the requestor
approvals (PMAs), and applications for currently approved by the Office of in the appeal would facilitate timely
investigational device exemptions Management and Budget as follows: The resolution of the decision under review.
(IDEs). collections of information in 21 CFR The guidance describes the collection of
A request for review under § 10.75 part 807, subpart E (premarket information not expressly specified
should be based on the information that notification) have been approved under under existing regulations such as: The
was already present in the OMB control number 0910–0120; the submission of the request for review,
administrative file at the time of the collections of information in 21 CFR minor clarifications as part of the
decision that is being reviewed as part 814 (premarket approval) have been request, and supporting information.
provided in § 10.75(d). New section approved under OMB control number In the Federal Register of October 21,
517A of the FD&C Act refers to 0910–0231; and the collections of 2015 (80 FR 63804), FDA published a
significant decisions regarding the information in 21 CFR part 812 60-day notice requesting public
information in the administrative file for (investigational device exemption) have comment on the proposed collection of
premarket notifications (section 510(k)); been approved under OMB control information. No comments were
PMAs (section 515); and IDEs (section number 0910–0078. received.
520(g)) submissions is collected under While CDRH already possesses in the FDA estimates the burden of this
existing regulations which specify the administrative file the information that collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent 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. Information regarding special indication of prevention of Clostridium
Leslie Kux, accommodations due to a disability, difficile infection recurrence.
Associate Commissioner for Policy. visitor parking, and transportation may FDA intends to make background
[FR Doc. 2016–08685 Filed 4–14–16; 8:45 am] be accessed at: http://www.fda.gov/ material available to the public no later
BILLING CODE 4164–01–P AdvisoryCommittees/ than 2 business days before the meeting.
AboutAdvisoryCommittees/ If FDA is unable to post the background
ucm408555.htm. material on its Web site prior to the
DEPARTMENT OF HEALTH AND Contact Person: Lauren D. Tesh, meeting, the background material will
HUMAN SERVICES Center for Drug Evaluation and be made publicly available at the
Research, Food and Drug location of the advisory committee
Food and Drug Administration meeting, and the background material
Administration, 10903 New Hampshire
[Docket No. FDA–2016–N–0001] Ave., Bldg. 31, Rm. 2417, Silver Spring, will be posted on FDA’s Web site after
the meeting. Background material is
MD 20993–0002, 301–796–9001, FAX:
Antimicrobial Drugs Advisory available at http://www.fda.gov/
301–847–8533, AMDAC@fda.hhs.gov, or
Committee; Notice of Meeting AdvisoryCommittees/Calendar/
FDA Advisory Committee Information
default.htm. Scroll down to the
AGENCY: Food and Drug Administration, Line, 1–800–741–8138 (301–443–0572
appropriate advisory committee meeting
HHS. in the Washington, DC area). A notice in
link.
ACTION: Notice. the Federal Register about last minute
Procedure: Interested persons may
modifications that impact a previously
This notice announces a forthcoming present data, information, or views,
announced advisory committee meeting
meeting of a public advisory committee orally or in writing, on issues pending
cannot always be published quickly before the committee. Written
of the Food and Drug Administration enough to provide timely notice.
(FDA). The meeting will be open to the submissions may be made to the contact
Therefore, you should always check the person on or before May 25, 2016. Oral
public. Agency’s Web site at http://
Name of Committee: Antimicrobial presentations from the public will be
www.fda.gov/AdvisoryCommittees/ scheduled between approximately 1:30
Drugs Advisory Committee. default.htm and scroll down to the
General Function of the Committee: p.m. and 2:30 p.m. Those individuals
appropriate advisory committee meeting interested in making formal oral
To provide advice and
link, or call the advisory committee presentations should notify the contact
asabaliauskas on DSK3SPTVN1PROD with NOTICES
recommendations to the Agency on
information line to learn about possible person and submit a brief statement of
FDA’s regulatory issues.
Date and Time: The meeting will be modifications before coming to the the general nature of the evidence or
held on June 9, 2016, from 8:30 a.m. to meeting. arguments they wish to present, the
5 p.m. Agenda: The committee will discuss names and addresses of proposed
Location: FDA White Oak Campus, biologics license application (BLA) participants, and an indication of the
10903 New Hampshire Ave., Bldg. 31 761046, bezlotoxumab (MK–6072) approximate time requested to make
Conference Center, the Great Room (Rm. injection, submitted by Merck Sharpe & their presentation on or before May 17,
1503), Silver Spring, MD 20993–0002. Dohme Corp., for the proposed 2016. Time allotted for each
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Document Created: 2016-04-15 00:55:53
Document Modified: 2016-04-15 00:55:53
| 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. | |
| Dates | Fax written comments on the collection of information by May 16, 2016. | |
| 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 | 81 FR 22277 |
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