81 FR 38711 - Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 114 (June 14, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 114 (June 14, 2016)
| Page Range | 38711-38712 | |
| FR Document | 2016-13988 |
[Federal Register Volume 81, Number 114 (Tuesday, June 14, 2016)] [Notices] [Pages 38711-38712] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-13988] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-1273] Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment.'' This draft guidance provides recommendations to industry for designing a nonclinical development program to support approval of drugs to treat osteoporosis. This guidance also discusses the nonclinical development of biopharmaceuticals (e.g., recombinant proteins and monoclonal antibodies). DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 15, 2016.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-2016-D-1273 for ``Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment; Draft Guidance for Industry.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential [[Page 38712]] 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. Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Gemma Kuijpers, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5374, Silver Spring, MD 20993-0002, 301- 796-1243. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment.'' This draft guidance provides recommendations to industry for designing a nonclinical development program to support approval of drugs to treat osteoporosis. In addition to the pharmacology and toxicology studies required to support development of a new drug or biologic, long-term nonclinical studies to evaluate effects on bone quality in adequate animal models and including bone-specific pharmacologic and toxicologic endpoints are needed. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on nonclinical evaluation of drugs intended for the treatment of osteoporosis. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. The Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501- 3520). The collections of information in 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910-0014 and 0910-0001, respectively. III. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: June 8, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-13988 Filed 6-13-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 114 / Tuesday, June 14, 2016 / Notices 38711
symptoms in adult patients with active speak is greater than can be reasonably DATES: Although you can comment on
ankylosing spondylitis; (5) reducing accommodated during the scheduled any guidance at any time (see 21 CFR
signs and symptoms and inducing and open public hearing session, FDA may 10.115(g)(5)), to ensure that the Agency
maintaining clinical remission in adult conduct a lottery to determine the considers your comment on this draft
patients with moderately to severely speakers for the scheduled open public guidance before it begins work on the
active Crohn’s disease who have had an hearing session. The contact person will final version of the guidance, submit
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therapy (ABP 501 would be indicated request to speak by June 20, 2016. on the draft guidance by August 15,
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patients if they have also lost response Agency is not responsible for providing as follows:
to or are intolerant to infliximab); (6) access to electrical outlets.
inducing and sustaining clinical FDA welcomes the attendance of the Electronic Submissions
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FDA intends to make background that if you include your name, contact
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than 2 business days before the meeting. Jill Hartzler Warner, identifies you in the body of your
If FDA is unable to post the background Associate Commissioner for Special Medical comments, that information will be
material on its Web site prior to the Programs. posted on http://www.regulations.gov.
meeting, the background material will [FR Doc. 2016–14017 Filed 6–13–16; 8:45 am] • If you want to submit a comment
be made publicly available at the BILLING CODE 4164–01–P
with confidential information that you
location of the advisory committee do not wish to be made available to the
meeting, and the background material public, submit the comment as a
will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND written/paper submission and in the
the meeting. Background material is HUMAN SERVICES manner detailed (see ‘‘Written/Paper
available at http://www.fda.gov/ Submissions’’ and ‘‘Instructions’’).
AdvisoryCommittees/Calendar/ Food and Drug Administration
Written/Paper Submissions
default.htm. Scroll down to the [Docket No. FDA–2016–D–1273]
appropriate advisory committee meeting Submit written/paper submissions as
link. follows:
Osteoporosis: Nonclinical Evaluation
Procedure: Interested persons may • Mail/Hand delivery/Courier (for
of Drugs Intended for Treatment; Draft
present data, information, or views, written/paper submissions): Division of
Guidance for Industry; Availability
orally or in writing, on issues pending Dockets Management (HFA–305), Food
before the committee. Written AGENCY: Food and Drug Administration, and Drug Administration, 5630 Fishers
submissions may be made to the contact HHS. Lane, Rm. 1061, Rockville, MD 20852.
person on or before June 27, 2016. Oral ACTION: Notice of availability. • For written/paper comments
presentations from the public will be submitted to the Division of Dockets
scheduled between approximately 1:30 SUMMARY: The Food and Drug Management, FDA will post your
p.m. and 3 p.m. Those individuals Administration (FDA or Agency) is comment, as well as any attachments,
interested in making formal oral announcing the availability of a draft except for information submitted,
presentations should notify the contact guidance for industry entitled marked and identified, as confidential,
person and submit a brief statement of ‘‘Osteoporosis: Nonclinical Evaluation if submitted as detailed in
the general nature of the evidence or of Drugs Intended for Treatment.’’ This ‘‘Instructions.’’
arguments they wish to present, the draft guidance provides Instructions: All submissions received
srobinson on DSK5SPTVN1PROD with NOTICES
names and addresses of proposed recommendations to industry for must include the Docket No. FDA–
participants, and an indication of the designing a nonclinical development 2016–D–1273 for ‘‘Osteoporosis:
approximate time requested to make program to support approval of drugs to Nonclinical Evaluation of Drugs
their presentation on or before June 17, treat osteoporosis. This guidance also Intended for Treatment; Draft Guidance
2016. Time allotted for each discusses the nonclinical development for Industry.’’ Received comments will
presentation may be limited. If the of biopharmaceuticals (e.g., recombinant be placed in the docket and, except for
number of registrants requesting to proteins and monoclonal antibodies). those submitted as ‘‘Confidential
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![38712 Federal Register / Vol. 81, No. 114 / Tuesday, June 14, 2016 / Notices
Submissions,’’ publicly viewable at Drug Administration, 10903 New DEPARTMENT OF HEALTH AND
http://www.regulations.gov or at the Hampshire Ave., Bldg. 22, Rm. 5374, HUMAN SERVICES
Division of Dockets Management Silver Spring, MD 20993–0002, 301–
between 9 a.m. and 4 p.m., Monday 796–1243. Health IT Standards Committee
through Friday. Advisory Meeting; Notice of Meeting
• Confidential Submissions—To SUPPLEMENTARY INFORMATION:
AGENCY: Office of the National
submit a comment with confidential I. Background Coordinator for Health Information
information that you do not wish to be
Technology, HHS.
made publicly available, submit your FDA is announcing the availability of
comments only as a written/paper a draft guidance for industry entitled ACTION: Notice of meeting.
submission. You should submit two ‘‘Osteoporosis: Nonclinical Evaluation This notice announces updated dates
copies total. One copy will include the of Drugs Intended for Treatment.’’ This for meetings of a public advisory
information you claim to be confidential draft guidance provides committee of the Office of the National
with a heading or cover note that states recommendations to industry for Coordinator for Health Information
‘‘THIS DOCUMENT CONTAINS designing a nonclinical development Technology (ONC). These meetings are
CONFIDENTIAL INFORMATION.’’ The program to support approval of drugs to open to the public.
Agency will review this copy, including treat osteoporosis. In addition to the Name of Committee: Health IT
the claimed confidential information, in pharmacology and toxicology studies Standards Committee.
its consideration of comments. The required to support development of a General Function of the Committee:
second copy, which will have the new drug or biologic, long-term To provide recommendations to the
claimed confidential information nonclinical studies to evaluate effects National Coordinator on standards,
redacted/blacked out, will be available on bone quality in adequate animal implementation specifications, and
for public viewing and posted on http:// models and including bone-specific certification criteria for the electronic
www.regulations.gov. Submit both pharmacologic and toxicologic exchange and use of health information
copies to the Division of Dockets endpoints are needed. for purposes of adoption, consistent
Management. If you do not wish your with the implementation of the Federal
name and contact information to be This draft guidance is being issued
consistent with FDA’s good guidance Health IT Strategic Plan, and in
made publicly available, you can accordance with policies developed by
provide this information on the cover practices regulation (21 CFR 10.115).
the Health IT Policy Committee.
sheet and not in the body of your The draft guidance, when finalized, will
comments and you must identify this represent the current thinking of FDA 2016 Meeting Dates and Times
information as ‘‘confidential.’’ Any on nonclinical evaluation of drugs • May 17, 2016, from 9:00 a.m. to 3:00
information marked as ‘‘confidential’’ intended for the treatment of p.m./Eastern Time
will not be disclosed except in osteoporosis. It does not establish any Æ This will be an in-person meeting
accordance with 21 CFR 10.20 and other rights for any person and is not binding at the Omni Shoreham Hotel, 2500
applicable disclosure law. For more on FDA or the public. You can use an Calvert Street NW., Washington, DC
information about FDA’s posting of alternative approach if it satisfies the 20008
comments to public dockets, see 80 FR requirements of the applicable statutes • June 8, 2016, from 9:30 a.m. to 12:00
56469, September 18, 2015, or access and regulations. p.m./Eastern Time
the information at: http://www.fda.gov/ Æ This will be a virtual meeting
regulatoryinformation/dockets/ II. The Paperwork Reduction Act of • June 23, 2016, from 9:00 a.m. to 3:00
default.htm. 1995 p.m./Eastern Time
Docket: For access to the docket to This guidance refers to previously Æ This will be an in-person meeting
read background documents or the at the Hyatt Regency Crystal City,
approved collections of information that
electronic and written/paper comments 2799 Jefferson Davis Highway,
are subject to review by the Office of
received, go to http:// Arlington, VA 22202
Management and Budget (OMB) under
www.regulations.gov and insert the • July 27, 2016 from 10:00 a.m. to 1:00
the Paperwork Reduction Act of 1995
docket number, found in brackets in the p.m./Eastern Time (replacing the
heading of this document, into the (44 U.S.C. 3501–3520). The collections
formerly announced July 13 and
‘‘Search’’ box and follow the prompts of information in 21 CFR parts 312 and
August 7 meetings)
and/or go to the Division of Dockets 314 have been approved under OMB Æ This will be a virtual meeting
Management, 5630 Fishers Lane, Rm. control numbers 0910–0014 and 0910–
0001, respectively. For meeting locations, web conference
1061, Rockville, MD 20852. information, and the most up-to-date
Submit written requests for single III. Electronic Access information, please visit the calendar on
copies of the draft guidance to the the ONC Web site, http://
Division of Drug Information, Center for Persons with access to the Internet www.healthit.gov/FACAS/calendar.
Drug Evaluation and Research, Food may obtain the draft guidance at either Contact Person: Michelle Consolazio,
and Drug Administration, 10001 New http://www.fda.gov/Drugs/ email: michelle.consolazio@hhs.gov.
Hampshire Ave., Hillandale Building, GuidanceCompliance Please email Michelle Consolazio for the
4th Floor, Silver Spring, MD 20993– RegulatoryInformation/Guidances/ most current information about
0002. Send one self-addressed adhesive default.htm or http:// meetings. A notice in the Federal
srobinson on DSK5SPTVN1PROD with NOTICES
label to assist that office in processing www.regulations.gov. Register about last minute modifications
your requests. See the SUPPLEMENTARY that impact a previously announced
Dated: June 8, 2016.
INFORMATION section for electronic advisory committee meeting cannot
access to the draft guidance document. Leslie Kux,
always be published quickly enough to
FOR FURTHER INFORMATION CONTACT: Associate Commissioner for Policy. provide timely notice.
Gemma Kuijpers, Center for Drug [FR Doc. 2016–13988 Filed 6–13–16; 8:45 am] Agenda: The committee will hear
Evaluation and Research, Food and BILLING CODE 4164–01–P reports from its workgroups/task forces
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Document Created: 2016-06-14 02:59:05
Document Modified: 2016-06-14 02:59:05
| 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 of availability. | |
| Dates | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 15, 2016. | |
| Contact | Gemma Kuijpers, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5374, Silver Spring, MD 20993-0002, 301- 796-1243. | |
| FR Citation | 81 FR 38711 |
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