CHEMBIOMED, LTD., Opportunity for a Hearing on a Proposal To Revoke U.S. License No. 0916, 1917-1919 [2015-00442]
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Federal Register / Vol. 80, No. 9 / Wednesday, January 14, 2015 / Notices
9. The response time with respect to the
provision of services to families and
children where an allegation of
child abuse or neglect has been
made.
10. For child protective service
personnel responsible for intake,
screening, assessment, and
investigation of child abuse and
neglect reports in the State—
A. information on the education,
qualifications, and training
requirements established by the
State for child protective service
professionals, including for entry
and advancement in the profession,
including advancement to
supervisory positions;
B. data of the education,
qualifications, and training of such
personnel;
C. demographic information of the
child protective service personnel;
and
D. information on caseload or
workload requirements for such
personnel, including requirements
for average number and maximum
number of cases per child
protective service worker and
supervisor.
11. The number of children reunited
with their families or receiving
family preservation services that,
within five years, result in
subsequent substantiated reports of
child abuse or neglect, including
the death of the child.
12. The number of children for whom
individuals were appointed by the
court to represent the best interests
of such children and the average
number of out of court contacts
between such individuals and
children.
13. The annual report containing the
summary of activities of the citizen
review panels of the State required
by subsection (c)(6).
14. The number of children under the
care of the State child protection
system who are transferred into the
custody of the State juvenile justice
system.
15. The number of children referred to
a child protective services system
under subsection (b)(2)(B)(ii).
16. The number of children determined
to be eligible for referral, and the
1917
number of children referred, under
subsection (b)(2)(B)(xxi), to agencies
providing early intervention
services under part C of the
Individuals with Disabilities
Education Act (20 U.S.C. 1431 et
seq.).
The Children’s Bureau proposes to
continue collecting the NCANDS data
through the two files of the Detailed
Case Data Component, the Child File
(the case-level component of NCANDS)
and the Agency File (additional
aggregate data, which cannot be
collected at the case level). Technical
assistance will be provided so that all
States may provide the Child File and
Agency File data to NCANDS.
There are no proposed changes to the
NCANDS data collection instruments.
New fields were implemented during
the previous OMB clearance cycle in
support of the CAPTA Reauthorization
Act of 2010 and to improve reporting on
federal performance measures.
Respondents: State governments, the
District of Columbia, and the
Commonwealth of Puerto Rico.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Detailed Case Data Component Child File and Agency File ..........................
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Instrument
52
1
82
4,264
Estimated Total Annual Burden
Hours: 4,264.
In compliance with the requirements
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information may be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
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17:15 Jan 13, 2015
Jkt 235001
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–00081 Filed 1–13–15; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1951]
CHEMBIOMED, LTD., Opportunity for a
Hearing on a Proposal To Revoke U.S.
License No. 0916
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00033
Fmt 4703
Sfmt 4703
The Food and Drug
Administration (FDA) is announcing an
opportunity for a hearing on a proposal
to revoke the biologics license (U.S.
License No. 0916) issued to
CHEMBIOMED, LTD. (CHEMBIOMED),
for the manufacture of Anti-A (Murine
Monoclonal), Anti-B (Murine
Monoclonal), Anti-Lea (Murine
Monoclonal) and Anti-Leb (Murine
Monoclonal). The proposed revocation
is based on information that the firm is
no longer in operation and the
manufacture of its licensed products has
been discontinued.
DATES: CHEMBIOMED may submit
electronic or written requests for a
hearing by February 13, 2015, and any
data and information justifying a
hearing by March 16, 2015. Other
interested persons may submit
electronic or written comments on the
proposed revocation by March 16, 2015.
ADDRESSES: Submit electronic requests
for a hearing, any data and information
justifying a hearing, and comments to
https://www.regulations.gov. Submit
written requests for a hearing, any data
and information justifying a hearing,
SUMMARY:
E:\FR\FM\14JAN1.SGM
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Federal Register / Vol. 80, No. 9 / Wednesday, January 14, 2015 / Notices
and any written comments on the
proposed revocation to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: John
Reilly, Center for Biologics Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993–0002, 240–402–7911.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with NOTICES
I. Background
FDA is initiating proceedings to
revoke the biologics license (U.S.
License No. 0916) issued to
CHEMBIOMED, 9515 107th St., Rm.
401, Edmonton AB T5K 2C3, Canada,
for the manufacture of Anti-A (Murine
Monoclonal), Anti-B (Murine
Monoclonal), Anti-Lea (Murine
Monoclonal) and Anti-Leb (Murine
Monoclonal). Proceedings to revoke U.S.
License No. 0916 are being initiated
under 21 Code of Federal Regulations
(CFR) 601.5(b) because FDA has
determined through various means that
a meaningful inspection of
CHEMBIOMED cannot be conducted
because the manufacturer is no longer in
operation. In addition, Health Canada
has advised FDA that CHEMBIOMED is
no longer in operation. According to the
Industry Canada Web site
(www.ic.gc.ca), CHEMBIOMED
(Corporation No. 0228176 and Business
No. (BN) 100938521RC0001 under the
governing legislation of the Canada
Business Corporations Act) was issued a
Certificate of Incorporation on August
15, 1977, and later was issued a
Certificate of Dissolution on March 17,
1999.
In a phone conversation that occurred
on July 7, 1992, a former CHEMBIOMED
employee informed FDA that
CHEMBIOMED was no longer in
business, had ceased the manufacture of
licensed products, and had also ceased
shipments of licensed products to the
United States.
In a letter dated June 16, 1995, FDA
requested from the Authorized Official
(Responsible Head) of CHEMBIOMED a
status update for the production of all
of the products for which
CHEMBIOMED held a U.S. license. This
letter requested that the firm notify FDA
in writing of the firm’s status and also
informed the Authorized Official that in
the absence of a response to this letter
that FDA would take action to revoke
CHEMBIOMED’s U.S. license. FDA did
not receive a response to its letter dated
June 16, 1995.
In a certified, return-receipt letter
dated October 18, 1995, FDA requested
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13:56 Jan 13, 2015
Jkt 235001
that the Authorized Official of
CHEMBIOMED inform FDA whether or
not the firm intended to pursue a
product license application supplement
request dated May 6, 1987. In the
October 18, 1995 letter, FDA also
informed the Authorized Official that
the product license application
supplement request had been placed in
the FDA inactive files. FDA did not
receive a response to its certified,
return-receipt letter dated October 18,
1995.
In a letter to CHEMBIOMED dated
December 19, 2012, FDA provided
notice of FDA’s intent to revoke U.S.
License No. 0916 and announced its
intent to offer an opportunity for a
hearing. FDA indicated that FDA
registrations for CHEMBIOMED
facilities have not been updated since
May 12, 1994. The letter also advised
the Authorized Official that, under 21
CFR 601.5(b)(1)(i) and (ii) of FDA’s
regulations, proceedings for license
revocation may be instituted when FDA
finds that authorized FDA employees
have been unable to gain access to an
establishment for the purpose of
carrying out an inspection, or when the
manufacturing of a product has been
discontinued to an extent that a
meaningful inspection cannot be made.
The December 19, 2012 letter to
CHEMBIOMED, sent via United Parcel
Service (UPS), was returned as
undeliverable.
II. Notice of Opportunity for Hearing
Because FDA has made reasonable
efforts to notify CHEMBIOMED of the
proposed revocation and no response
has been received from the firm, FDA is
proceeding under 21 CFR 12.21(b) and
issuing this notice of opportunity for a
hearing on a proposal to revoke the
biologics license (US. License No. 0916)
issued to CHEMBIOMED for the
manufacture of Anti-A (Murine
Monoclonal), Anti-B (Murine
Monoclonal), Anti-Lea (Murine
Monoclonal) and Anti-Leb (Murine
Monoclonal).
FDA has placed copies of the
documents relevant to the proposed
revocation on file with the Division of
Dockets Management (see ADDRESSES)
under the docket number found in
brackets in the heading of this notice.
These documents include the following:
(1) A phone conversation record dated
July 7, 1992 between FDA and a former
CHEMBIOMED employee; (2) an FDA
letter to the Authorized Official of
CHEMBIOMED dated June 16, 1995; (3)
a certified, return-receipt letter from
FDA to the Authorized Official of
CHEMBIOMED dated October 18, 1995;
(4) a UPS Express Mail, signature
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
required letter from FDA to the
Authorized Official of CHEMBIOMED,
dated December 19, 2012, and returned
as undeliverable; and (5) Industry
Canada information that documents
CHEMBIOMED, Corporation No.
0228176 and BN 100938521RC0001
under the governing legislation of the
Canada Business Corporations Act, was
issued a Certificate of Incorporation on
August 15, 1977, and later was issued a
Certificate of Dissolution on March 17,
1999. These documents are available for
public examination 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 https://
www.regulations.gov.
CHEMBIOMED may submit an
electronic or written request for a
hearing to the Division of Dockets
Management by February 13, 2015, and
any data and information justifying a
hearing to the Division of Dockets
Management by March 16, 2015. Other
interested persons may submit
electronic or written comments on the
proposed license revocation to the
Division of Dockets Management by
March 16, 2015. The failure of the
licensee, CHEMBIOMED, to file a timely
electronic or written request for a
hearing constitutes an election by the
licensee not to avail itself of the
opportunity for a hearing concerning the
proposed license revocation (§ 12.22(b)).
FDA’s procedures and requirements
governing a notice of opportunity for a
hearing, notice of appearance and
request for a hearing, grant or denial of
a hearing, and submission of data and
information to justify a hearing on a
proposed revocation of a license are
contained in 21 CFR parts 12 and 601.
A request for a hearing may not rest on
mere allegations or denials, but must set
forth a genuine and substantial issue of
fact that requires a hearing (§ 12.24(b)).
If it conclusively appears from the face
of the data, information, and factual
analyses submitted in support of the
request for a hearing that there is no
genuine and substantial issue of fact for
resolution at a hearing, the
Commissioner of Food and Drugs (the
Commissioner) will deny the hearing
request, making findings and
conclusions that justify the denial
(§ 12.24(b)(3)).
Only one copy of any submission
need be provided to FDA. Submissions
are to be identified with the docket
number found in brackets in the
heading of this document. Such
submissions, except for data and
information prohibited from public
disclosure under 21 CFR 10.20(j)(2)(i),
21 U.S.C. 331(j) or 18 U.S.C. 1905, may
be examined in the Division of Dockets
E:\FR\FM\14JAN1.SGM
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Federal Register / Vol. 80, No. 9 / Wednesday, January 14, 2015 / Notices
Management (see ADDRESSES) between 9
a.m. and 4 p.m., Monday through Friday
and will be posted to the docket at
https://www.regulations.gov.
This notice is issued under section
351 of the Public Health Service Act (42
U.S.C. 262) and sections 201, 501, 502,
505, and 701 of the Federal Food, Drug,
and Cosmetic Acts (21 U.S.C. 321, 351,
352, 355, and 371), and under the
authority delegated to the Commissioner
and redelegated to the Director and
Deputy Director of the Center for
Biologics Evaluation and Research (FDA
Staff Manual Guide 1410.203).
Dated: January 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–00442 Filed 1–13–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Determining Mental Health
Professional Shortage Areas of
Greatest Need
Health Resources and Services
Administration (HRSA), Health and
Human Services (HHS).
ACTION: updating of the scoring criteria
for determining mental health
professional shortage areas (HPSA) of
greatest need.
AGENCY:
In accordance with the
requirements of section 333A(b)(1) of
SUMMARY:
the Public Health Service (PHS) Act, as
amended by the Health Care Safety Net
Amendments of 2002, 42 U.S.C. 254f1(b)(1), the Secretary of HHS shall
establish the criteria which she will use
to make determinations under section
333A(a)(1)(A) of the HPSAs with the
greatest shortages. This notice sets forth
revised criteria for determining mental
health HPSAs with the greatest shortage.
This updates the previous criteria
published on May 30, 2003.
DATES: Effective January 14, 2015.
FOR FURTHER INFORMATION CONTACT: Kae
Brickerd, Ph.D., Chief, Shortage
Designation Branch, Bureau of Health
Workforce, Division of Policy and
Shortage Designation, Health Resources
and Services Administration, 11W14
Parklawn Building, 5600 Fishers Lane,
Rockville, Maryland 20857, 301 945–
0828, kbrickerd@hrsa.gov.
SUPPLEMENTARY INFORMATION: Section
332 of the PHS Act, 42 U.S.C. 254e,
provides that the Secretary shall
designate HPSAs based on criteria
established by regulation. HPSAs are
defined in Section 332 to include (1)
urban and rural geographic areas with
shortages of health professionals, (2)
population groups with such shortages,
and (3) facilities with such shortages.
The required regulations setting forth
the criteria for designating HPSAs are
codified at 42 CFR part 5. Section
333A(a)(1)(A) of the PHS Act and
requires that the Secretary give priority
in the assignment of National Health
Service Corps personnel to entities
serving HPSAs with the greatest health
professional shortage. Section 333A(b)
of the PHS Act requires that the
Secretary establish criteria specifying
the manner in which she determines
HPSAs of greatest shortage and publish
the criteria, and any revisions to the
criteria, in the Federal Register. The
criteria established by the Secretary
create a method for scoring HPSAs
based on relative shortage.
In the Federal Register notice on May
30, 2003, 68 FR 32531, the following
criteria were identified for determining
scores for mental health HPSAs:
population to provider ratio, percentage
of the population below 100 percent of
poverty, travel time to the nearest
alternative source of care, the ratio of
children under age 18 to adults age 18–
64, the ratio of adults over age 65 to
adults age 18–64, and alcohol and
substance abuse prevalence rates. Each
factor is given points and the score is
the sum of the points, up to 25. This
notice modifies and provides
clarification to the point scale for the
population to provider ratio component
of the formula, based on an assessment
that the current point scale for the
population to provider ratio does not
adequately reflect the level of shortage.
As a result of the modifications, the
point values assigned for some
population to provider ratios will see
either a small increase or decrease,
while others may remain unchanged.
All other scoring criteria and point
scales remain the same as published in
the previous notice.
The point scale published in 2003 for
the population to provider ratio is
presented in the following table:
Psychiatrist ratio
Core mental health ratio
>45,000:0 AND ..............................................................................
>4,500:0 .......................................................................................
>4500:1 and <6000:11 .................................................................
>6000:1 and <9,000:1 .................................................................
>4,500:1 and <6,000:1 ................................................................
>4,500:0 and <6,000:0 ................................................................
>6,000:1 .......................................................................................
......................................................................................................
>9,000:1 .......................................................................................
<20,000:1
<30,000:1
<45,000:1
>20,000:1
>30,000:1
1>
mstockstill on DSK4VPTVN1PROD with NOTICES
1919
and >15,000:1 AND .....................................................
and >15,000:1 OR .......................................................
and > 20,000:1 AND ....................................................
AND ..............................................................................
......................................................................................
Score
= Greater Than; < = Less Than
To reflect the mental health services
available in a community, entities
applying for Mental Health HPSAs are
encouraged to report on the number of
both psychiatrists and core mental
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17:15 Jan 13, 2015
Jkt 235001
health providers rendering services. The
revised point scale is as follows:
For Geographic High Need and
Population HPSAs, as defined in the
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
designation criteria set forth in 42 CFR
part 5, Appendix C, Part 1, and A.4.
BILLING CODE 4165–15–P
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7
6
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]]>Agencies
[Federal Register Volume 80, Number 9 (Wednesday, January 14, 2015)]
[Notices]
[Pages 1917-1919]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-00442]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1951]
CHEMBIOMED, LTD., Opportunity for a Hearing on a Proposal To
Revoke U.S. License No. 0916
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for a hearing on a proposal to revoke the biologics license
(U.S. License No. 0916) issued to CHEMBIOMED, LTD. (CHEMBIOMED), for
the manufacture of Anti-A (Murine Monoclonal), Anti-B (Murine
Monoclonal), Anti-Le\a\ (Murine Monoclonal) and Anti-Le\b\ (Murine
Monoclonal). The proposed revocation is based on information that the
firm is no longer in operation and the manufacture of its licensed
products has been discontinued.
DATES: CHEMBIOMED may submit electronic or written requests for a
hearing by February 13, 2015, and any data and information justifying a
hearing by March 16, 2015. Other interested persons may submit
electronic or written comments on the proposed revocation by March 16,
2015.
ADDRESSES: Submit electronic requests for a hearing, any data and
information justifying a hearing, and comments to https://www.regulations.gov. Submit written requests for a hearing, any data
and information justifying a hearing,
[[Page 1918]]
and any written comments on the proposed revocation to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: John Reilly, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is initiating proceedings to revoke the biologics license (U.S.
License No. 0916) issued to CHEMBIOMED, 9515 107th St., Rm. 401,
Edmonton AB T5K 2C3, Canada, for the manufacture of Anti-A (Murine
Monoclonal), Anti-B (Murine Monoclonal), Anti-Le\a\ (Murine Monoclonal)
and Anti-Le\b\ (Murine Monoclonal). Proceedings to revoke U.S. License
No. 0916 are being initiated under 21 Code of Federal Regulations (CFR)
601.5(b) because FDA has determined through various means that a
meaningful inspection of CHEMBIOMED cannot be conducted because the
manufacturer is no longer in operation. In addition, Health Canada has
advised FDA that CHEMBIOMED is no longer in operation. According to the
Industry Canada Web site (www.ic.gc.ca), CHEMBIOMED (Corporation No.
0228176 and Business No. (BN) 100938521RC0001 under the governing
legislation of the Canada Business Corporations Act) was issued a
Certificate of Incorporation on August 15, 1977, and later was issued a
Certificate of Dissolution on March 17, 1999.
In a phone conversation that occurred on July 7, 1992, a former
CHEMBIOMED employee informed FDA that CHEMBIOMED was no longer in
business, had ceased the manufacture of licensed products, and had also
ceased shipments of licensed products to the United States.
In a letter dated June 16, 1995, FDA requested from the Authorized
Official (Responsible Head) of CHEMBIOMED a status update for the
production of all of the products for which CHEMBIOMED held a U.S.
license. This letter requested that the firm notify FDA in writing of
the firm's status and also informed the Authorized Official that in the
absence of a response to this letter that FDA would take action to
revoke CHEMBIOMED's U.S. license. FDA did not receive a response to its
letter dated June 16, 1995.
In a certified, return-receipt letter dated October 18, 1995, FDA
requested that the Authorized Official of CHEMBIOMED inform FDA whether
or not the firm intended to pursue a product license application
supplement request dated May 6, 1987. In the October 18, 1995 letter,
FDA also informed the Authorized Official that the product license
application supplement request had been placed in the FDA inactive
files. FDA did not receive a response to its certified, return-receipt
letter dated October 18, 1995.
In a letter to CHEMBIOMED dated December 19, 2012, FDA provided
notice of FDA's intent to revoke U.S. License No. 0916 and announced
its intent to offer an opportunity for a hearing. FDA indicated that
FDA registrations for CHEMBIOMED facilities have not been updated since
May 12, 1994. The letter also advised the Authorized Official that,
under 21 CFR 601.5(b)(1)(i) and (ii) of FDA's regulations, proceedings
for license revocation may be instituted when FDA finds that authorized
FDA employees have been unable to gain access to an establishment for
the purpose of carrying out an inspection, or when the manufacturing of
a product has been discontinued to an extent that a meaningful
inspection cannot be made. The December 19, 2012 letter to CHEMBIOMED,
sent via United Parcel Service (UPS), was returned as undeliverable.
II. Notice of Opportunity for Hearing
Because FDA has made reasonable efforts to notify CHEMBIOMED of the
proposed revocation and no response has been received from the firm,
FDA is proceeding under 21 CFR 12.21(b) and issuing this notice of
opportunity for a hearing on a proposal to revoke the biologics license
(US. License No. 0916) issued to CHEMBIOMED for the manufacture of
Anti-A (Murine Monoclonal), Anti-B (Murine Monoclonal), Anti-Le\a\
(Murine Monoclonal) and Anti-Le\b\ (Murine Monoclonal).
FDA has placed copies of the documents relevant to the proposed
revocation on file with the Division of Dockets Management (see
ADDRESSES) under the docket number found in brackets in the heading of
this notice. These documents include the following: (1) A phone
conversation record dated July 7, 1992 between FDA and a former
CHEMBIOMED employee; (2) an FDA letter to the Authorized Official of
CHEMBIOMED dated June 16, 1995; (3) a certified, return-receipt letter
from FDA to the Authorized Official of CHEMBIOMED dated October 18,
1995; (4) a UPS Express Mail, signature required letter from FDA to the
Authorized Official of CHEMBIOMED, dated December 19, 2012, and
returned as undeliverable; and (5) Industry Canada information that
documents CHEMBIOMED, Corporation No. 0228176 and BN 100938521RC0001
under the governing legislation of the Canada Business Corporations
Act, was issued a Certificate of Incorporation on August 15, 1977, and
later was issued a Certificate of Dissolution on March 17, 1999. These
documents are available for public examination 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 https://www.regulations.gov.
CHEMBIOMED may submit an electronic or written request for a
hearing to the Division of Dockets Management by February 13, 2015, and
any data and information justifying a hearing to the Division of
Dockets Management by March 16, 2015. Other interested persons may
submit electronic or written comments on the proposed license
revocation to the Division of Dockets Management by March 16, 2015. The
failure of the licensee, CHEMBIOMED, to file a timely electronic or
written request for a hearing constitutes an election by the licensee
not to avail itself of the opportunity for a hearing concerning the
proposed license revocation (Sec. 12.22(b)).
FDA's procedures and requirements governing a notice of opportunity
for a hearing, notice of appearance and request for a hearing, grant or
denial of a hearing, and submission of data and information to justify
a hearing on a proposed revocation of a license are contained in 21 CFR
parts 12 and 601. A request for a hearing may not rest on mere
allegations or denials, but must set forth a genuine and substantial
issue of fact that requires a hearing (Sec. 12.24(b)). If it
conclusively appears from the face of the data, information, and
factual analyses submitted in support of the request for a hearing that
there is no genuine and substantial issue of fact for resolution at a
hearing, the Commissioner of Food and Drugs (the Commissioner) will
deny the hearing request, making findings and conclusions that justify
the denial (Sec. 12.24(b)(3)).
Only one copy of any submission need be provided to FDA.
Submissions are to be identified with the docket number found in
brackets in the heading of this document. Such submissions, except for
data and information prohibited from public disclosure under 21 CFR
10.20(j)(2)(i), 21 U.S.C. 331(j) or 18 U.S.C. 1905, may be examined in
the Division of Dockets
[[Page 1919]]
Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through
Friday and will be posted to the docket at https://www.regulations.gov.
This notice is issued under section 351 of the Public Health
Service Act (42 U.S.C. 262) and sections 201, 501, 502, 505, and 701 of
the Federal Food, Drug, and Cosmetic Acts (21 U.S.C. 321, 351, 352,
355, and 371), and under the authority delegated to the Commissioner
and redelegated to the Director and Deputy Director of the Center for
Biologics Evaluation and Research (FDA Staff Manual Guide 1410.203).
Dated: January 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00442 Filed 1-13-15; 8:45 am]
BILLING CODE 4164-01-P
