81 FR 42365 - Gifts to the Food and Drug Administration: Evaluation and Acceptance: Draft Guidance for the Public and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 125 (June 29, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 125 (June 29, 2016)
| Page Range | 42365-42366 | |
| FR Document | 2016-15385 |
[Federal Register Volume 81, Number 125 (Wednesday, June 29, 2016)] [Notices] [Pages 42365-42366] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-15385] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-4361] Gifts to the Food and Drug Administration: Evaluation and Acceptance: Draft Guidance for the Public and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for the public and FDA staff entitled ``Gifts to FDA: Evaluation and Acceptance.'' The Secretary of the Department of Health and Human Services (HHS) has the authority to accept conditional or unconditional gifts on behalf of the United States. The Secretary has delegated this gift authority to the Commissioner of Food and Drugs. This guidance provides the process and principles we will use in implementing this authority. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on this draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 12, 2016.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 [[Page 42366]] 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-2015-D-4361 for ``Gifts to FDA: Evaluation and Acceptance: Draft Guidance for the Public and FDA Staff; Availability''. 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. Submit written requests for single copies of the draft guidance to the Office of Policy, Office of the Commissioner, Food and Drug Administration, Bldg. 32, Rm. 4235, 10903 New Hampshire Ave., Silver Spring, MD, 20993. 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: Aaron Zimmerman, Office of Policy, Office of the Commissioner, Food and Drug Administration, Bldg. 32, Rm. 4235, 10903 New Hampshire Ave., Silver Spring, MD, 20993. 301-796-0339, [email protected]. Alternate contact: Office of Policy, 301- 796-4830. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for the public and FDA staff entitled ``Gifts to FDA: Evaluation and Acceptance.'' The Secretary of HHS has the authority to accept conditional or unconditional gifts on behalf of the United States. The Secretary has delegated this gift authority to the Commissioner of Food and Drugs. This guidance provides the process and principles we will use in implementing this authority. FDA will consider gifts from all sources on a case-by-case basis using a balancing test, described in the draft guidance. While any person may offer a gift, there are five reasons we should reject a gift without additional evaluation. We should not accept a gift if: (1) The donor imposes conditions that are illegal, are contrary to public policy, are unreasonable to administer, are contrary to FDA's current policies and procedures, or are contrary to generally accepted public standards; (2) the donor requires us to provide the donor with some privilege, concession, or other present or future benefit in return for the gift; (3) a debarred entity offers the gift; (4) a different authority or financial mechanism applies; or (5) the total costs associated with acceptance are expected to exceed the cost of purchasing a similar item and the cost of normal care and maintenance. This draft guidance is being issued consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent our current thinking on this matter. 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. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/RegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: June 23, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-15385 Filed 6-28-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 125 / Wednesday, June 29, 2016 / Notices 42365
Conference Center, the Great Room (Rm. Procedure: On August 4, 2016, from Dated: June 23, 2016.
1503), Silver Spring, MD 20993–0002. 9:30 a.m. to 5 p.m., the meeting is open Jill Hartzler Warner,
Answers to commonly asked questions to the public. Interested persons may Associate Commissioner for Special Medical
including information regarding special present data, information, or views, Programs.
accommodations due to a disability, orally or in writing, on issues pending [FR Doc. 2016–15361 Filed 6–28–16; 8:45 am]
visitor parking, and transportation may before the committees. Written BILLING CODE 4164–01–P
be accessed at: http://www.fda.gov/ submissions may be made to the contact
AdvisoryCommittees/ person on or before July 21, 2016. Oral
AboutAdvisoryCommittees/ presentations from the public will be DEPARTMENT OF HEALTH AND
ucm408555.htm. HUMAN SERVICES
scheduled between approximately 1
FOR FURTHER INFORMATION CONTACT: p.m. to 2 p.m. Those individuals Food and Drug Administration
Philip A. Bautista, Center for Drug interested in making formal oral
Evaluation and Research, Food and presentations should notify the contact [Docket No. FDA–2015–D–4361]
Drug Administration, 10903 New person and submit a brief statement of
Hampshire Ave., Bldg. 31, Rm. 2417, Gifts to the Food and Drug
the general nature of the evidence or Administration: Evaluation and
Silver Spring, MD 20993–0002, 301– arguments they wish to present, the
796–9001, FAX: 301–847–8533, Acceptance: Draft Guidance for the
names and addresses of proposed Public and Food and Drug
AADPAC@fda.hhs.gov, or FDA
participants, and an indication of the Administration Staff; Availability
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the approximate time requested to make
their presentation on or before July 13, AGENCY: Food and Drug Administration,
Washington, DC area). A notice in the HHS.
Federal Register about last minute 2016. Time allotted for each
presentation may be limited. If the ACTION: Notice of availability.
modifications that impact a previously
announced advisory committee meeting number of registrants requesting to SUMMARY: The Food and Drug
cannot always be published quickly speak is greater than can be reasonably Administration (FDA or we) is
enough to provide timely notice. accommodated during the scheduled announcing the availability of a draft
Therefore, you should always check the open public hearing session, FDA may guidance for the public and FDA staff
Agency’s Web site at http:// conduct a lottery to determine the entitled ‘‘Gifts to FDA: Evaluation and
www.fda.gov/AdvisoryCommittees/ speakers for the scheduled open public Acceptance.’’ The Secretary of the
default.htm and scroll down to the hearing session. The contact person will Department of Health and Human
appropriate advisory committee meeting notify interested persons regarding their Services (HHS) has the authority to
link, or call the advisory committee request to speak by July 14, 2016. accept conditional or unconditional
information line to learn about possible gifts on behalf of the United States. The
Closed Committee Deliberations: On
modifications before coming to the Secretary has delegated this gift
meeting. August 4, 2016, from 8 a.m. to 9:30 a.m.,
the meeting will be closed to permit authority to the Commissioner of Food
SUPPLEMENTARY INFORMATION: Agenda: discussion and review of trade secret and Drugs. This guidance provides the
The committees will discuss new drug process and principles we will use in
and/or confidential commercial
application (NDA) 208630, morphine implementing this authority.
information (5 U.S.C. 552b(c)(4)).
sulfate extended-release tablets, DATES: Although you can comment on
During this session, the committees will
submitted by Egalet U.S., Inc., with the any guidance at any time (see 21 CFR
discuss the drug development program
proposed indication of the management 10.115(g)(5)), to ensure that we consider
of pain severe enough to require daily, of an investigational product.
your comment on this draft guidance
around-the-clock, long-term opioid Persons attending FDA’s advisory before we begin work on the final
treatment and for which alternative committee meetings are advised that the version of the guidance, submit either
treatment options are inadequate. It has Agency is not responsible for providing electronic or written comments on the
been formulated with the intent to access to electrical outlets. draft guidance by September 12, 2016.
provide abuse-deterrent properties. The FDA welcomes the attendance of the ADDRESSES: You may submit comments
committees will be asked to discuss public at its advisory committee as follows:
whether the data submitted by the meetings and will make every effort to
applicant are sufficient to support Electronic Submissions
accommodate persons with disabilities.
labeling of the product with the Submit electronic comments in the
If you require accommodations due to a
properties expected to deter abuse. following way:
FDA intends to make background disability, please Philip Bautista at least • Federal eRulemaking Portal: http://
material available to the public no later 7 days in advance of the meeting. www.regulations.gov. Follow the
than 2 business days before the meeting. FDA is committed to the orderly instructions for submitting comments.
If FDA is unable to post the background conduct of its advisory committee Comments submitted electronically,
material on its Web site prior to the meetings. Please visit our Web site at including attachments, to http://
meeting, the background material will http://www.fda.gov/ www.regulations.gov will be posted to
be made publicly available at the AdvisoryCommittees/ the docket unchanged. Because your
location of the advisory committee AboutAdvisoryCommittees/ comment will be made public, you are
meeting, and the background material solely responsible for ensuring that your
mstockstill on DSK3G9T082PROD with NOTICES
ucm111462.htm for procedures on
will be posted on FDA’s Web site after public conduct during advisory comment does not include any
the meeting. Background material is committee meetings. confidential information that you or a
available at http://www.fda.gov/ third party may not wish to be posted,
AdvisoryCommittees/Calendar/ Notice of this meeting is given under such as medical information, your or
default.htm. Scroll down to the the Federal Advisory Committee Act (5 anyone else’s Social Security number, or
appropriate advisory committee meeting U.S.C. app. 2). confidential business information, such
link. as a manufacturing process. Please note
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![42366 Federal Register / Vol. 81, No. 125 / Wednesday, June 29, 2016 / Notices
that if you include your name, contact information marked as ‘‘confidential’’ This draft guidance is being issued
information, or other information that will not be disclosed except in consistent with our good guidance
identifies you in the body of your accordance with 21 CFR 10.20 and other practices regulation (21 CFR 10.115).
comments, that information will be applicable disclosure law. For more The draft guidance, when finalized, will
posted on http://www.regulations.gov. information about FDA’s posting of represent our current thinking on this
• If you want to submit a comment comments to public dockets, see 80 FR matter. It does not establish any rights
with confidential information that you 56469, September 18, 2015, or access for any person and is not binding on
do not wish to be made available to the the information at: http://www.fda.gov/ FDA or the public. You can use an
public, submit the comment as a regulatoryinformation/dockets/ alternative approach if it satisfies the
written/paper submission and in the default.htm. requirements of the applicable statutes
manner detailed (see ‘‘Written/Paper Submit written requests for single and regulations.
Submissions’’ and ‘‘Instructions’’). copies of the draft guidance to the Office
II. Electronic Access
Written/Paper Submissions of Policy, Office of the Commissioner,
Food and Drug Administration, Bldg. Persons with access to the Internet
Submit written/paper submissions as 32, Rm. 4235, 10903 New Hampshire may obtain the document at either
follows: Ave., Silver Spring, MD, 20993. Send http://www.fda.gov/
• Mail/Hand delivery/Courier (for one self-addressed adhesive label to RegulatoryInformation/Guidances/
written/paper submissions): Division of default.htm or http://
assist that office in processing your
Dockets Management (HFA–305), Food www.regulations.gov.
requests. See the SUPPLEMENTARY
and Drug Administration, 5630 Fishers
INFORMATION section for electronic Dated: June 23, 2016.
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments access to the draft guidance document. Leslie Kux,
submitted to the Division of Dockets FOR FURTHER INFORMATION CONTACT: Associate Commissioner for Policy.
Management, FDA will post your Aaron Zimmerman, Office of Policy, [FR Doc. 2016–15385 Filed 6–28–16; 8:45 am]
comment, as well as any attachments, Office of the Commissioner, Food and BILLING CODE 4164–01–P
except for information submitted, Drug Administration, Bldg. 32, Rm.
marked and identified, as confidential, 4235, 10903 New Hampshire Ave.,
if submitted as detailed in Silver Spring, MD, 20993. 301–796– DEPARTMENT OF HEALTH AND
‘‘Instructions.’’ 0339, aaron.zimmerman@fda.hhs.gov. HUMAN SERVICES
Instructions: All submissions received Alternate contact: Office of Policy, 301–
must include the Docket No. FDA– 796–4830. National Institutes of Health
2015–D–4361 for ‘‘Gifts to FDA: SUPPLEMENTARY INFORMATION:
Evaluation and Acceptance: Draft Center For Scientific Review; Notice of
Guidance for the Public and FDA Staff; I. Background Closed Meetings
Availability’’. Received comments will FDA is announcing the availability of Pursuant to section 10(d) of the
be placed in the docket and, except for a draft guidance for the public and FDA Federal Advisory Committee Act, as
those submitted as ‘‘Confidential staff entitled ‘‘Gifts to FDA: Evaluation amended (5 U.S.C. App.), notice is
Submissions,’’ publicly viewable at and Acceptance.’’ The Secretary of HHS hereby given of the following meetings.
http://www.regulations.gov or at the has the authority to accept conditional The meetings will be closed to the
Division of Dockets Management or unconditional gifts on behalf of the public in accordance with the
between 9 a.m. and 4 p.m., Monday United States. The Secretary has provisions set forth in sections
through Friday. delegated this gift authority to the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
• Confidential Submissions—To Commissioner of Food and Drugs. This as amended. The grant applications and
submit a comment with confidential guidance provides the process and the discussions could disclose
information that you do not wish to be principles we will use in implementing confidential trade secrets or commercial
made publicly available, submit your this authority. property such as patentable material,
comments only as a written/paper FDA will consider gifts from all and personal information concerning
submission. You should submit two sources on a case-by-case basis using a individuals associated with the grant
copies total. One copy will include the balancing test, described in the draft applications, the disclosure of which
information you claim to be confidential guidance. While any person may offer a would constitute a clearly unwarranted
with a heading or cover note that states gift, there are five reasons we should invasion of personal privacy.
‘‘THIS DOCUMENT CONTAINS reject a gift without additional
CONFIDENTIAL INFORMATION.’’ The evaluation. We should not accept a gift Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Agency will review this copy, including if: (1) The donor imposes conditions Conflict: Transport Synapses and
the claimed confidential information, in that are illegal, are contrary to public Cytoskeletal Dynamics.
its consideration of comments. The policy, are unreasonable to administer, Date: July 13, 2016.
second copy, which will have the are contrary to FDA’s current policies Time: 1:00 p.m. to 4:00 p.m.
claimed confidential information and procedures, or are contrary to Agenda: To review and evaluate grant
redacted/blacked out, will be available generally accepted public standards; (2) applications.
for public viewing and posted on http:// the donor requires us to provide the Place: National Institutes of Health, 6701
www.regulations.gov. Submit both donor with some privilege, concession, Rockledge Drive, Bethesda, MD 20892,
copies to the Division of Dockets or other present or future benefit in (Telephone Conference Call).
mstockstill on DSK3G9T082PROD with NOTICES
Contact Person: Joanne T Fujii, Ph.D.,
Management. If you do not wish your return for the gift; (3) a debarred entity Scientific Review Officer, Center for
name and contact information to be offers the gift; (4) a different authority or Scientific Review, National Institutes of
made publicly available, you can financial mechanism applies; or (5) the Health, 6701 Rockledge Drive, Room 4184,
provide this information on the cover total costs associated with acceptance MSC 7850, Bethesda, MD 20892, (301) 435–
sheet and not in the body of your are expected to exceed the cost of 1178, fujiij@csr.nih.gov.
comments and you must identify this purchasing a similar item and the cost This notice is being published less than 15
information as ‘‘confidential.’’ Any of normal care and maintenance. days prior to the meeting due to the timing
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Document Created: 2018-02-08 07:43:03
Document Modified: 2018-02-08 07:43:03
| 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 we consider your comment on this draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 12, 2016. | |
| Contact | Aaron Zimmerman, Office of Policy, Office of the Commissioner, Food and Drug Administration, Bldg. 32, Rm. 4235, 10903 New Hampshire Ave., Silver Spring, MD, 20993. 301-796-0339, [email protected] Alternate contact: Office of Policy, 301- 796-4830. | |
| FR Citation | 81 FR 42365 |
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