81 FR 5465 - Agency Information Collection Activities: Proposed Collection; Comment Request; Applications for Food and Drug Administration Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Valid or Will Not Be Infringed
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 21 (February 2, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 21 (February 2, 2016)
| Page Range | 5465-5467 | |
| FR Document | 2016-01782 |
[Federal Register Volume 81, Number 21 (Tuesday, February 2, 2016)] [Notices] [Pages 5465-5467] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-01782] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0662] Agency Information Collection Activities: Proposed Collection; Comment Request; Applications for Food and Drug Administration Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Valid or Will Not Be Infringed AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting requirements for submission and listing of patent information associated with a new drug application (NDA), an amendment, or a supplement. DATES: Submit either electronic or written comments on the collection of information by April 4, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2013-N-0662 for ``Agency Information Collection Activities: Proposed Collection; Comment Request; Applications for Food and Drug Administration Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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]. [[Page 5466]] SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Applications for FDA Approval To Market a New Drug: Patent Submission and Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed--OMB Control Number 0910- 0513--Extension Section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(b)(1)) requires all NDA applicants to file, as part of the NDA, ``the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug.'' Section 505(c)(2) of the FD&C Act (21 U.S.C. 355(c)(2)) imposes a similar patent submission obligation on holders of approved NDAs when the NDA holder could not have submitted the patent information with its application. Under Sec. 505(b)(1) of the FD&C Act, we publish patent information after approval of an NDA application in the list entitled ``Approved Drug Products with Therapeutic Equivalence Evaluations'' (the Orange Book). If patent information is submitted after NDA approval, Sec. 505(c)(2) of the FD&C Act directs us to publish the information upon its submission. FDA regulations at Sec. Sec. 314.50(h) (21 CFR 314.50(h)) and 314.53 (21 CFR 314.53) clarify the types of patent information that must and must not be submitted to FDA as part of an NDA, an amendment, or a supplement, and require persons submitting an NDA, an amendment, or a supplement, or submitting information on a patent after NDA approval, to make a detailed patent declaration using Form FDA 3542a and Form FDA 3542. The reporting burden for submitting an NDA, an amendment, or supplement in accordance with Sec. 314.50 (a) through (f), and (k) has been estimated by FDA and the collection of information has been approved by OMB under OMB control number 0910-0001. We are not re- estimating these approved burdens in this document. Only the reporting burdens associated with patent submission and listing, as explained below, are estimated in this document. The information collection reporting requirements are as follows: Section 314.50(h) requires that an NDA, an amendment, or a supplement contain patent information described under Sec. 314.53. Section 314.53 requires that an applicant submitting an NDA, an amendment, or a supplement, except as provided in Sec. 314.53(d)(2), submit on Forms 3542 and 3542a, the required patent information described in this section. Compliance with the information collection burdens under Sec. Sec. 314.50(h) and 314.53 consists of submitting with an NDA, an amendment, or a supplement (collectively referred to as ``application'') the required patent declaration(s) on Form 3542a for each ``patent that claims the drug or a method of using the drug that is the subject of the new drug application or amendment or supplement to it and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug product'' (Sec. 314.53(b)). Such patents claim the drug substance (active ingredient), drug product (formulation and composition), or method of use. If a patent is issued after the application is filed with FDA, but before the application is approved, the applicant must submit the required patent information on Form 3542a as an amendment to the application, within 30 days of the date of issuance of the patent. Within 30 days after the date of approval of an application, the applicant must submit Form 3542 for each patent that claims the drug substance (active ingredient), drug product (formulation and composition), or approved method of use for listing in the Orange Book. In addition, for patents issued after the date of approval of an application, Form 3542 must be submitted within 30 days of the date of issuance of the patent. FDA requests OMB approval for the following information collection: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of 21 CFR 314.50 (citing Sec. Number of responses per Total annual Hours per Total hours 314.53) respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- Form FDA 3542a............... 241 3.4 819 20 16,380 Form FDA 3542................ 200 3.4 680 5 3,400 ---------------------------------------------------------------------------------- Total.................... .............. .............. .............. .............. 19,780 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs, operating and maintenance costs associated with this collection of information. [[Page 5467]] The numbers of patents submitted to FDA for listing in the Orange Book in 2012, 2013, and 2014 were 458, 509, and 617, respectively, for an annual average of 528 (458 patents + 509 patents + 617 patents)/3 years = 528 patents/year). Because many of these individual patents are included in multiple NDA submissions, there could be multiple declarations for a single patent. From our previous review of submissions, we believe that approximately 14 percent of the patents submitted are included in multiple NDA submissions, and thus require multiple patent declarations. Therefore, we estimate that 74 (528 patents x 14 percent) patents will be multiple listings, and there will be a total of 602 patents (528 patents + 74 patents = 602 patents) declared on Form FDA 3542. We approved 86, 94, and 107 NDAs in calendar years 2012, 2013, and 2014, respectively, of which we estimate based on our previous review that approximately 71 percent submitted patent information for listing in the Orange Book. The remaining NDAs submitted Form FDA 3542 as required and declared that there were no relevant patents. We also approved approximately 101, 101, and 110 NDA supplements in FYs 2012, 2013, and 2014, respectively, for which submission of a patent declaration would be required. We estimate there will be 200 instances (based on an average of 96 NDA approvals and 104 supplement approvals per year) where an NDA holder would be affected by the patent declaration requirements, and that each of these NDA holders would, on average, submit 3.4 declarations (602 patent declarations + 74 no relevant patent declarations)/200 instances = 3.4 declarations per instance) on Form FDA 3542. We filed 112, 116, and 113 NDAs in 2012, 2013, and 2014, respectively, and 112, 112, 156 NDA supplements in 2012, 2013, and 2014, respectively, for which submission of a patent declaration would be required. We estimate there will be 241 instances (based on an average of 114 NDAs filed and 127 NDA supplements filed per year) where an NDA holder would be affected by the patent declaration requirements. We estimate, based on a proportional increase from the number of declarations for approved NDAs, that there will be an annual total of 819 declarations (241 instances x 3.4 declarations per instance = 819 declarations) on Form FDA 3542a submitted with these applications. Based upon information provided by regulated entities and other information, we previously estimated that the information collection burden associated with Sec. 314.50(h) (citing Sec. 314.53) and Forms FDA 3542 and 3542a will be approximately 5 hours and 20 hours per response, respectively. Dated: January 27, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-01782 Filed 2-1-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 21 / Tuesday, February 2, 2016 / Notices 5465
ADDRESSES sections above and state extension of an existing collection of Applications for Food and Drug
whether or not they are in the information, and to allow 60 days for Administration Approval to Market a
community in which the hospital is public comment in response to the New Drug: Patent Submission and
located. notice. This notice solicits comments on Listing Requirements and Application
the reporting requirements for of 30-Month Stays on Approval of
IV. Collection of Information
submission and listing of patent Abbreviated New Drug Applications.’’
Requirements
information associated with a new drug Received comments will be placed in
This document does not impose application (NDA), an amendment, or a the docket and, except for those
information collection requirements, supplement. submitted as ‘‘Confidential
that is, reporting, recordkeeping or DATES: Submit either electronic or Submissions,’’ publicly viewable at
third-party disclosure requirements. written comments on the collection of http://www.regulations.gov or at the
Consequently, there is no need for information by April 4, 2016. Division of Dockets Management
review by the Office of Management and between 9 a.m. and 4 p.m., Monday
ADDRESSES: You may submit comments
Budget under the authority of the through Friday.
as follows:
Paperwork Reduction Act of 1995 (44 • Confidential Submissions—To
U.S.C. 3501 et seq.). Electronic Submissions submit a comment with confidential
V. Response to Public Comments Submit electronic comments in the information that you do not wish to be
following way: made publicly available, submit your
Because of the large number of public comments only as a written/paper
comments we normally receive on • Federal eRulemaking Portal: http://
www.regulations.gov. Follow the submission. You should submit two
Federal Register documents, we are not copies total. One copy will include the
able to acknowledge or respond to them instructions for submitting comments.
Comments submitted electronically, information you claim to be confidential
individually. We will consider all with a heading or cover note that states
comments we receive by the date and including attachments, to http://
www.regulations.gov will be posted to ‘‘THIS DOCUMENT CONTAINS
time specified in the DATES section of CONFIDENTIAL INFORMATION’’. The
this preamble, and, when we proceed the docket unchanged. Because your
comment will be made public, you are Agency will review this copy, including
with a subsequent document, we will the claimed confidential information, in
respond to the comments in the solely responsible for ensuring that your
comment does not include any its consideration of comments. The
preamble to that document. second copy, which will have the
confidential information that you or a
Dated: January 6, 2016. claimed confidential information
third party may not wish to be posted,
Andrew M. Slavitt, such as medical information, your or redacted/blacked out, will be available
Acting Administrator, Centers for Medicare anyone else’s Social Security number, or for public viewing and posted on http://
& Medicaid Services. confidential business information, such www.regulations.gov. Submit both
[FR Doc. 2016–01830 Filed 2–1–16; 8:45 am] as a manufacturing process. Please note copies to the Division of Dockets
BILLING CODE 4120–01–P that if you include your name, contact Management. If you do not wish your
information, or other information that name and contact information to be
identifies you in the body of your made publicly available, you can
DEPARTMENT OF HEALTH AND comments, that information will be provide this information on the cover
HUMAN SERVICES posted on http://www.regulations.gov. sheet and not in the body of your
• If you want to submit a comment comments and you must identify this
Food and Drug Administration information as ‘‘confidential.’’ Any
with confidential information that you
[Docket No. FDA–2013–N–0662] do not wish to be made available to the information marked as ‘‘confidential’’
public, submit the comment as a will not be disclosed except in
Agency Information Collection written/paper submission and in the accordance with 21 CFR 10.20 and other
Activities: Proposed Collection; manner detailed (see ‘‘Written/Paper applicable disclosure law. For more
Comment Request; Applications for Submissions’’ and ‘‘Instructions’’). information about FDA’s posting of
Food and Drug Administration comments to public dockets, see 80 FR
Approval to Market a New Drug: Patent Written/Paper Submissions 56469, September 18, 2015, or access
Submission and Listing Requirements Submit written/paper submissions as the information at: http://www.fda.gov/
and Application of 30-Month Stays on follows: regulatoryinformation/dockets/
Approval of Abbreviated New Drug • Mail/Hand delivery/Courier (for default.htm.
Applications Certifying That a Patent written/paper submissions): Division of Docket: For access to the docket to
Claiming a Drug Is Valid or Will Not Be Dockets Management (HFA–305), Food read background documents or the
Infringed and Drug Administration, 5630 Fishers electronic and written/paper comments
Lane, Rm. 1061, Rockville, MD 20852. received, go to http://
AGENCY: Food and Drug Administration,
HHS. • For written/paper comments www.regulations.gov and insert the
submitted to the Division of Dockets docket number, found in brackets in the
ACTION: Notice. heading of this document, into the
Management, FDA will post your
SUMMARY: The Food and Drug comment, as well as any attachments, ‘‘Search’’ box and follow the prompts
Administration (FDA) is announcing an except for information submitted, and/or go to the Division of Dockets
opportunity for public comment on the marked and identified, as confidential, Management, 5630 Fishers Lane, Rm.
wgreen on DSK2VPTVN1PROD with NOTICES
proposed collection of certain if submitted as detailed in 1061, Rockville, MD 20852.
information by the Agency. Under the ‘‘Instructions.’’ FOR FURTHER INFORMATION CONTACT: FDA
Paperwork Reduction Act of 1995 (the Instructions: All submissions received PRA Staff, Office of Operations, Food
PRA), Federal Agencies are required to must include the Docket No. FDA– and Drug Administration, 8455
publish notice in the Federal Register 2013–N–0662 for ‘‘Agency Information Colesville Rd., COLE–14526, Silver
concerning each proposed collection of Collection Activities: Proposed Spring, MD 20993–0002, PRAStaff@
information, including each proposed Collection; Comment Request; fda.hhs.gov.
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![Federal Register / Vol. 81, No. 21 / Tuesday, February 2, 2016 / Notices 5467
The numbers of patents submitted to information collection burden DEPARTMENT OF HEALTH AND
FDA for listing in the Orange Book in associated with § 314.50(h) (citing HUMAN SERVICES
2012, 2013, and 2014 were 458, 509, § 314.53) and Forms FDA 3542 and
and 617, respectively, for an annual 3542a will be approximately 5 hours Food and Drug Administration
average of 528 (458 patents + 509 and 20 hours per response, respectively. [Docket No. FDA–2016–N–0001]
patents + 617 patents)/3 years = 528 Dated: January 27, 2016.
patents/year). Because many of these Leslie Kux, The Arthritis Foundation—Food and
individual patents are included in Associate Commissioner for Policy. Drug Administration Accelerating
multiple NDA submissions, there could Osteoarthritis Clinical Trials Workshop
[FR Doc. 2016–01782 Filed 2–1–16; 8:45 am]
be multiple declarations for a single
patent. From our previous review of BILLING CODE 4164–01–P AGENCY: Food and Drug Administration,
submissions, we believe that HHS.
approximately 14 percent of the patents ACTION: Notice of workshop.
DEPARTMENT OF HEALTH AND
submitted are included in multiple NDA HUMAN SERVICES SUMMARY: Osteoarthritis is the most
submissions, and thus require multiple common form of arthritis, and occurs
patent declarations. Therefore, we Food and Drug Administration when the cartilage that cushions the
estimate that 74 (528 patents × 14 bones of the joint break down and the
percent) patents will be multiple [Docket No. FDA–2012–N–0129] bones begin to rub together. This can
listings, and there will be a total of 602 cause pain, swelling, and loss of motion
patents (528 patents + 74 patents = 602 Agency Information Collection of the joint. The Food and Drug
patents) declared on Form FDA 3542. Activities; Announcement of Office of Administration’s (FDA) Center for Drug
We approved 86, 94, and 107 NDAs in Management and Budget Approval; Evaluation and Research, in co-
calendar years 2012, 2013, and 2014, General Licensing Provisions; Section sponsorship with the Arthritis
respectively, of which we estimate 351(k) Biosimilar Applications Foundation is announcing a workshop
based on our previous review that entitled, ‘‘Accelerating OA Clinical
approximately 71 percent submitted AGENCY: Food and Drug Administration,
Trials Workshop’’. The purpose of the
patent information for listing in the HHS.
workshop is to discuss
Orange Book. The remaining NDAs ACTION: Notice. recommendations from the international
submitted Form FDA 3542 as required Arthritis Foundation Accelerating
and declared that there were no relevant SUMMARY: The Food and Drug
Administration (FDA) is announcing Osteoarthritis Clinical Trial workgroup
patents. We also approved and identify next steps in forging new
approximately 101, 101, and 110 NDA that a collection of information entitled
‘‘General Licensing Provisions; Section approaches to osteoarthritis clinical
supplements in FYs 2012, 2013, and trials that may improve the likelihood of
2014, respectively, for which 351(k) Biosimilar Applications’’ has
been approved by the Office of successful conduct and outcomes of
submission of a patent declaration these trials and lead to the development
would be required. We estimate there Management and Budget (OMB) under
the Paperwork Reduction Act of 1995. of safe and effective treatments for
will be 200 instances (based on an osteoarthritis.
average of 96 NDA approvals and 104 FOR FURTHER INFORMATION CONTACT: FDA
supplement approvals per year) where PRA Staff, Office of Operations, Food DATES: The workshop will be held on
an NDA holder would be affected by the and Drug Administration, 8455 February 24, 2016, from 8 a.m. to 5:30
patent declaration requirements, and Colesville Rd., COLE–14526, Silver p.m., and February 25, 2016, from 8 a.m.
that each of these NDA holders would, Spring, MD 20993–0002, PRAStaff@ to 2 p.m.
on average, submit 3.4 declarations (602 fda.hhs.gov. ADDRESSES: The workshop will be held
patent declarations + 74 no relevant at the Atlanta Airport Hilton, 1031
SUPPLEMENTARY INFORMATION: On July 8,
patent declarations)/200 instances = 3.4 Virginia Ave., Atlanta, GA 30354.
2015, the Agency submitted a proposed
declarations per instance) on Form FDA collection of information entitled FOR FURTHER INFORMATION CONTACT:
3542. We filed 112, 116, and 113 NDAs ‘‘General Licensing Provisions; Section Sarah Yim, Office of New Drugs, Center
in 2012, 2013, and 2014, respectively, 351(k) Biosimilar Applications’’ to OMB for Drug Evaluation and Research,
and 112, 112, 156 NDA supplements in for review and clearance under 44 email: sarah.yim@fda.hhs.gov; Amanda
2012, 2013, and 2014, respectively, for U.S.C. 3507. An Agency may not Niskar, Arthritis Foundation, Inc., 1330
which submission of a patent conduct or sponsor, and a person is not West Peachtree St., Atlanta, GA 30309,
declaration would be required. We required to respond to, a collection of 404–964–7545, FAX: 404–965–7807,
estimate there will be 241 instances information unless it displays a email: aniskar@arthritis.org; or Becky
(based on an average of 114 NDAs filed currently valid OMB control number. Bosworth, Arthritis Foundation, Inc.,
and 127 NDA supplements filed per OMB has now approved the information 1330 West Peachtree St., Atlanta, GA
year) where an NDA holder would be collection and has assigned OMB 30309, 404–965–7673, email:
affected by the patent declaration control number 0910–0719. The bbosworth@arthritis.org.
requirements. We estimate, based on a approval expires on December 31, 2018. SUPPLEMENTARY INFORMATION:
proportional increase from the number A copy of the supporting statement for
of declarations for approved NDAs, that I. Background
this information collection is available
there will be an annual total of 819 on the Internet at http:// The osteoarthritis (OA) community of
wgreen on DSK2VPTVN1PROD with NOTICES
declarations (241 instances × 3.4 www.reginfo.gov/public/do/PRAMain. clinicians, physicians and scientists
declarations per instance = 819 have been challenged to get new
declarations) on Form FDA 3542a Dated: January 27, 2016. treatments to market so that people with
submitted with these applications. Leslie Kux, OA can benefit at the point of care. The
Based upon information provided by Associate Commissioner for Policy. Arthritis Foundation and FDA are
regulated entities and other information, [FR Doc. 2016–01783 Filed 2–1–16; 8:45 am] convening experts to discuss alternative
we previously estimated that the BILLING CODE 4164–01–P approaches to clinical trials in OA.
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Document Created: 2016-02-02 00:32:20
Document Modified: 2016-02-02 00:32:20
| 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 | Submit either electronic or written comments on the collection of information by April 4, 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 5465 |
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