80 FR 31604 - Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the States and the Food and Drug Administration; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 106 (June 3, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 106 (June 3, 2015)
| Page Range | 31604-31604 | |
| FR Document | 2015-13466 |
[Federal Register Volume 80, Number 106 (Wednesday, June 3, 2015)] [Notices] [Page 31604] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-13466] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-1459] Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the States and the Food and Drug Administration; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability; extension of comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is extending the comment period in the notice of availability that appeared in the Federal Register of February 19, 2015. In that notice of availability, FDA requested comments on a draft standard memorandum of understanding (MOU) entitled ``Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the State of [insert State] and the U.S. Food and Drug Administration.'' The draft standard MOU describes the responsibilities of any State that chooses to sign the MOU in investigating and responding to complaints related to compounded human drug products distributed outside the State and in addressing the interstate distribution of inordinate amounts of compounded human drug products. The Agency is taking this action to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period in the notice of availability published on February 19, 2015 (80 FR 8874) which includes comment on information collection issues under the Paperwork Reduction Act of 1995 (the PRA). Submit either electronic or written comments on the draft standard MOU or on information collection issues under the PRA by July 20, 2015. ADDRESSES: Submit written requests for single copies of the MOU to Edisa Gozun, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, suite 5100, Silver Spring, MD 20993-0002. Send one self-addressed label to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft standard MOU. Submit electronic comments on the new draft standard MOU or on the collection of information to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Edisa Gozun, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, suite 5100, Silver Spring, MD 20993-0002, 301-796-3110. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of February 19, 2015 (80 FR 8874), FDA published a notice of availability of a draft standard MOU entitled ``Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the State of [insert State] and the U.S. Food and Drug Administration'' with a 120-day comment period to request comments on the draft standard MOU. The draft standard MOU describes the responsibilities of any State that chooses to sign the MOU in: (1) Investigating and responding to complaints related to compounded human drug products distributed outside the State and (2) addressing the interstate distribution of inordinate amounts of compounded human drug products. Comments were also requested on information collection issues under the PRA. The notice of availability also announced the withdrawal, effective February 19, 2015, of an earlier draft standard MOU entitled ``Memorandum of Understanding on Interstate Distribution of Compounded Drug Products'' that published on January 21, 1999 (64 FR 3301). The January 1999 draft standard MOU is superseded by the February 2015 draft standard MOU. The Agency is extending the comment period both for the draft standard MOU and for information collection issues under the PRA for 30 days, until July 20, 2015. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying resolution of these important issues. II. Request for Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the draft standard MOU at http://www.regulations.gov. Dated: May 29, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-13466 Filed 6-2-15; 8:45 am] BILLING CODE 4164-01-P
![31604 Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Notices
Dated: May 29, 2015. addressed label to assist that office in or written comments to the Division of
Leslie Kux, processing your request. See the Dockets Management (see ADDRESSES). It
Associate Commissioner for Policy. SUPPLEMENTARY INFORMATION section for is only necessary to send one set of
[FR Doc. 2015–13471 Filed 6–2–15; 8:45 am] electronic access to the draft standard comments. Identify comments with the
BILLING CODE 4164–01–P
MOU. docket number found in brackets in the
Submit electronic comments on the heading of this document. Received
new draft standard MOU or on the comments may be seen in the Division
DEPARTMENT OF HEALTH AND collection of information to http:// of Dockets Management between 9 a.m.
HUMAN SERVICES www.regulations.gov. Submit written and 4 p.m., Monday through Friday, and
comments to the Division of Dockets will be posted to the docket at http://
Food and Drug Administration Management (HFA–305), Food and Drug www.regulations.gov.
[Docket No. FDA–2014–N–1459] Administration, 5630 Fishers Lane, rm.
III. Electronic Access
1061, Rockville, MD 20852.
Memorandum of Understanding FOR FURTHER INFORMATION CONTACT:
Persons with access to the Internet
Addressing Certain Distributions of Edisa Gozun, Center for Drug Evaluation may obtain the draft standard MOU at
Compounded Human Drug Products and Research, Food and Drug http://www.regulations.gov.
Between the States and the Food and Administration, 10903 New Hampshire Dated: May 29, 2015.
Drug Administration; Extension of Ave., Bldg. 51, suite 5100, Silver Spring, Leslie Kux,
Comment Period MD 20993–0002, 301–796–3110. Associate Commissioner for Policy.
AGENCY: Food and Drug Administration, SUPPLEMENTARY INFORMATION: [FR Doc. 2015–13466 Filed 6–2–15; 8:45 am]
HHS. I. Background BILLING CODE 4164–01–P
ACTION:Notice of availability; extension In the Federal Register of February
of comment period. 19, 2015 (80 FR 8874), FDA published DEPARTMENT OF HEALTH AND
SUMMARY: The Food and Drug a notice of availability of a draft HUMAN SERVICES
Administration (FDA or Agency) is standard MOU entitled ‘‘Memorandum
of Understanding Addressing Certain Health Resources and Services
extending the comment period in the
Distributions of Compounded Human Administration
notice of availability that appeared in
the Federal Register of February 19, Drug Products Between the State of
[insert State] and the U.S. Food and Graduate Psychology Education
2015. In that notice of availability, FDA Program
requested comments on a draft standard Drug Administration’’ with a 120-day
memorandum of understanding (MOU) comment period to request comments AGENCY: Health Resources and Services
entitled ‘‘Memorandum of on the draft standard MOU. The draft Administration, HHS.
Understanding Addressing Certain standard MOU describes the ACTION: Notice of Class Deviation from
Distributions of Compounded Human responsibilities of any State that chooses Competition Requirements for Graduate
Drug Products Between the State of to sign the MOU in: (1) Investigating Psychology Education Program from
[insert State] and the U.S. Food and and responding to complaints related to Open to Limited Competition.
Drug Administration.’’ The draft compounded human drug products
standard MOU describes the distributed outside the State and (2) SUMMARY: The Health Resources and
responsibilities of any State that chooses addressing the interstate distribution of Services Administration (HRSA) is
to sign the MOU in investigating and inordinate amounts of compounded issuing a limited competition for awards
responding to complaints related to human drug products. Comments were among the 40 current Graduate
compounded human drug products also requested on information collection Psychology Education (GPE) Program
distributed outside the State and in issues under the PRA. The notice of grantees whose project periods end June
addressing the interstate distribution of availability also announced the 30, 2016. No more than $1,000,000 will
inordinate amounts of compounded withdrawal, effective February 19, 2015, be made available in federal fiscal year
human drug products. The Agency is of an earlier draft standard MOU (FY) 2015 in the form of 1-year project
taking this action to allow interested entitled ‘‘Memorandum of period grants. These awards are
persons additional time to submit Understanding on Interstate Distribution specifically for interprofessional
comments. of Compounded Drug Products’’ that training of doctoral psychology graduate
published on January 21, 1999 (64 FR students and interns to address the
DATES: FDA is extending the comment 3301). The January 1999 draft standard psychological needs of military
period in the notice of availability MOU is superseded by the February personnel, veterans, and their families
published on February 19, 2015 (80 FR 2015 draft standard MOU. in civilian and community-based
8874) which includes comment on The Agency is extending the comment settings, including those in rural areas.
information collection issues under the period both for the draft standard MOU An estimated five grants will be
Paperwork Reduction Act of 1995 (the and for information collection issues awarded with a ceiling amount of
PRA). Submit either electronic or under the PRA for 30 days, until July 20, $190,000 per grant for 1 year. These
written comments on the draft standard 2015. The Agency believes that a 30-day funds will be used to establish, expand,
MOU or on information collection extension allows adequate time for and/or enhance activities that were
issues under the PRA by July 20, 2015. interested persons to submit comments funded under the FY 2013 GPE
tkelley on DSK3SPTVN1PROD with NOTICES
ADDRESSES: Submit written requests for without significantly delaying Program.
single copies of the MOU to Edisa resolution of these important issues. Program funds are to be used for
Gozun, Center for Drug Evaluation and stipend support for interns and doctoral
Research, Food and Drug II. Request for Comments students, faculty development,
Administration, 10903 New Hampshire Interested persons may submit either curriculum and instructional design,
Ave., Bldg. 51, suite 5100, Silver Spring, electronic comments regarding this program content enhancement, program
MD 20993–0002. Send one self- document to http://www.regulations.gov infrastructure development, and the
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Document Created: 2015-12-15 15:08:50
Document Modified: 2015-12-15 15:08:50
| 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; extension of comment period. | |
| Dates | FDA is extending the comment period in the notice of availability published on February 19, 2015 (80 FR 8874) which includes comment on information collection issues under the Paperwork Reduction Act of 1995 (the PRA). Submit either electronic or written comments on the draft standard MOU or on information collection issues under the PRA by July 20, 2015. | |
| Contact | Edisa Gozun, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, suite 5100, Silver Spring, MD 20993-0002, 301-796-3110. | |
| FR Citation | 80 FR 31604 |
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