Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board), National Institute for Occupational Safety and Health (NIOSH), 37741-37742 [2014-15522]
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Federal Register / Vol. 79, No. 127 / Wednesday, July 2, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
mstockstill on DSK4VPTVN1PROD with NOTICES
Advisory Board on Radiation and
Worker Health (ABRWH or Advisory
Board), National Institute for
Occupational Safety and Health
(NIOSH)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), and pursuant to the
requirements of 42 CFR 83.15(a), the
Centers for Disease Control and
Prevention (CDC), announces the
following meeting of the
aforementioned committee:
Board Public Meeting Time and Date
(All times are Mountain Time):
8:15 a.m.–5:30 p.m., July 29, 2014
Public Comment Time and Date (All
times are Mountain Time):
5:30 p.m.–6:30 p.m.*, July 29, 2014
*Please note that the public comment
periods may end before the times
indicated, following the last call for
comments. Members of the public who
wish to provide public comments should
plan to attend public comment sessions
at the start times listed.
Place: Hotel On The Falls, 475 River
Parkway, Idaho Falls, Idaho 83402;
Phone: (208) 523–8000; Fax: (208) 529–
9610. Audio Conference Call via FTS
Conferencing. The USA toll-free, dial-in
number is 1–866–659–0537 with a pass
code of 9933701. Live Meeting
CONNECTION: https://
www.livemeeting.com/cc/cdc/
join?id=988QJ4&role=attend&
pw=ABRWH; Meeting ID: 988QJ4; Entry
Code: ABRWH
Status: Open to the public, limited
only by the space available. The meeting
space accommodates approximately 100
people.
Background: The Advisory Board was
established under the Energy Employees
Occupational Illness Compensation
Program Act of 2000 to advise the
President on a variety of policy and
technical functions required to
implement and effectively manage the
new compensation program. Key
functions of the Advisory Board include
providing advice on the development of
probability of causation guidelines
which have been promulgated by the
Department of Health and Human
Services (HHS) as a final rule, advice on
methods of dose reconstruction which
have also been promulgated by HHS as
a final rule, advice on the scientific
validity and quality of dose estimation
and reconstruction efforts being
performed for purposes of the
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compensation program, and advice on
petitions to add classes of workers to the
Special Exposure Cohort (SEC).
In December 2000, the President
delegated responsibility for funding,
staffing, and operating the Advisory
Board to HHS, which subsequently
delegated this authority to the CDC.
NIOSH implements this responsibility
for CDC. The charter was issued on
August 3, 2001, renewed at appropriate
intervals, and will expire on August 3,
2015.
Purpose: This Advisory Board is
charged with a) providing advice to the
Secretary, HHS, on the development of
guidelines under Executive Order
13179; b) providing advice to the
Secretary, HHS, on the scientific
validity and quality of dose
reconstruction efforts performed for this
program; and c) upon request by the
Secretary, HHS, advising the Secretary
on whether there is a class of employees
at any Department of Energy facility
who were exposed to radiation but for
whom it is not feasible to estimate their
radiation dose, and on whether there is
reasonable likelihood that such
radiation doses may have endangered
the health of members of this class.
Matters for Discussion: The agenda for
the Advisory Board meeting includes:
NIOSH Program Update; Department of
Labor Program Update; Department of
Energy Program Update; SEC petitions
for: General Atomics (La Jolla, CA), and
Simonds Saw and Steel (Lockport, NY);
SEC Issues Work Group Report on
‘‘Sufficient Accuracy’’/Co-Worker Dose
Modeling; Worker Outreach Work
Group Report; SEC Petitions Update;
and Board Work Session.
The agenda is subject to change as
priorities dictate.
In the event an individual cannot
attend, written comments may be
submitted in accordance with the
redaction policy provided below. Any
written comments received will be
provided at the meeting and should be
submitted to the contact person below
well in advance of the meeting.
Policy on Redaction of Board Meeting
Transcripts (Public Comment): (1) If a
person making a comment gives his or
her personal information, no attempt
will be made to redact the name;
however, NIOSH will redact other
personally identifiable information,
such as contact information, social
security numbers, case numbers, etc., of
the commenter. (2) If an individual in
making a statement reveals personal
information (e.g., medical or
employment information) about
themselves that information will not
usually be redacted. The NIOSH
Freedom of Information Act (FOIA)
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37741
coordinator will, however, review such
revelations in accordance with the
Federal Advisory Committee Act and if
deemed appropriate, will redact such
information. (3) If a commenter reveals
personal information concerning a
living third party, that information will
be reviewed by the NIOSH FOIA
coordinator, and upon determination, if
deemed appropriated, such information
will be redacted, unless the disclosure
is made by the third party’s authorized
representative under the Energy
Employees Occupational Illness
Compensation Program Act (EEOICPA)
program. (4) In general, information
concerning a deceased third party may
be disclosed; however, such information
will be redacted if (a) the disclosure is
made by an individual other than the
survivor claimant, a parent, spouse, or
child, or the authorized representative
of the deceased third party; (b) if it is
unclear whether the third party is living
or deceased; or (c) the information is
unrelated or irrelevant to the purpose of
the disclosure. (5) The Board will take
reasonable steps to ensure that
individuals making public comment are
aware of the fact that their comments
(including their name, if provided) will
appear in a transcript of the meeting
posted on a public Web site. Such
reasonable steps include: (a) A
statement read at the start of each public
comment period stating that transcripts
will be posted and names of speakers
will not be redacted; (b) A printed copy
of the statement mentioned in (a) above
will be displayed on the table where
individuals sign up to make public
comments; (c) A statement such as
outlined in (a) above will also appear
with the agenda for a Board Meeting
when it is posted on the NIOSH Web
site; (d) A statement such as in (a) above
will appear in the Federal Register
Notice that announces Board and
Subcommittee meetings.
Contact Person For More Information:
Theodore Katz, Designated Federal
Officer, NIOSH, CDC, 1600 Clifton Road
NE., MS E–20, Atlanta, Georgia 30333,
telephone: (513) 533–6800, toll free: 1–
800–CDC–INFO, email: dcas@cdc.gov.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
Notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
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37742
Federal Register / Vol. 79, No. 127 / Wednesday, July 2, 2014 / Notices
Prevention and the Agency for Toxic
Substances and Disease Registry.
Gary Johnson,
Acting Director, Management Analysis and
Services Office Centers for Disease Control
and Prevention.
[FR Doc. 2014–15522 Filed 7–1–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–1444]
Final Guidance; Pharmacy
Compounding of Human Drug
Products Under Section 503A of the
Federal Food, Drug, and Cosmetic Act;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of a
guidance entitled ‘‘Pharmacy
Compounding of Human Drug Products
Under Section 503A of the Federal
Food, Drug, and Cosmetic Act.’’ The
guidance announces the Agency’s
intention with regard to enforcement of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) to regulate entities
that compound drugs, now that the
FD&C Act has been amended by the
Drug Quality and Security Act (DQSA).
The guidance reflects the Agency’s
current thinking on the issues addressed
by the guidance.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Office of Communications, Division of
Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://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:
Marissa Chaet Brykman, Center for Drug
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
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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
FDA is announcing the availability of
a guidance entitled ‘‘Pharmacy
Compounding of Human Drug Products
Under Section 503A of the Federal
Food, Drug, and Cosmetic Act.’’ The
guidance provides information to
compounders of human drug products
on the Agency’s application of section
503A of the FD&C Act (21 U.S.C. 353a)
and current enforcement policies
relating to the compounding of human
drug products.
Section 503A of the FD&C Act
describes the conditions that must be
satisfied for drug products compounded
by a licensed pharmacist or licensed
physician to be exempt from the
following three sections of the FD&C
Act: (1) Section 501(a)(2)(B) (21 U.S.C.
351(a)(2)(B)) (concerning current good
manufacturing practice); (2) section
502(f)(1) (21 U.S.C. 352(f)(1))
(concerning the labeling of drugs with
adequate directions for use); and (3)
section 505 (21 U.S.C. 355) (concerning
the approval of drugs under new drug
applications or abbreviated new drug
applications). All other applicable
provisions of the FD&C Act remain in
effect for compounded drugs, however,
even if the conditions in section 503A
are met.
Previously, the conditions of section
503A of the FD&C Act also included
restrictions on the advertising or
promotion of the compounding of any
particular drug, class of drug, or type of
drug, and the solicitation of
prescriptions for compounded drugs.
These provisions were challenged in
court and held unconstitutional by the
U.S. Supreme Court in 2002.1 In 2013,
the DQSA amended section 503A of the
FD&C Act to remove the
unconstitutional advertising, promotion,
and solicitation provisions. As a result,
it is necessary to explain FDA’s current
thinking with regard to section 503A of
the FD&C Act. Several provisions of
section 503A of the FD&C Act require
rulemaking and consultation with a
Pharmacy Compounding Advisory
Committee to implement. In the
guidance, FDA explains how those
provisions will be applied pending
those consultations and rulemaking.
Among other things, the guidance
restates the provisions in section 503A
1 See Thompson v. Western States Med. Ctr., 535
U.S. 357 (2002).
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Frm 00032
Fmt 4703
Sfmt 4703
of the FD&C Act that remain in effect,
describes FDA’s interim policies with
respect to specific provisions in section
503A that require implementing
regulations or other actions, and
contains a non-exhaustive list of
potential enforcement actions against
individuals or firms that compound
human drug products that do not meet
the conditions of section 503A.
In the Federal Register of December 4,
2013 (78 FR 72901), FDA issued a
document announcing the availability of
the draft version of this guidance and
the withdrawal of both the May 2002
Compliance Policy Guide entitled
‘‘Pharmacy Compounding’’ and the
November 1998 guidance for industry
entitled ‘‘Enforcement Policy During
Implementation of Section 503A of the
Federal Food, Drug, and Cosmetic Act.’’
The comment period on the draft
guidance ended on February 3, 2014.
Many of the received comments raise
issues that the Agency intends to
address in other policy documents and
were not directly pertinent to the topics
addressed in this guidance. These
comments will be further considered if
relevant to another policy document
developed by the Agency.
FDA made the following changes in
the final guidance: (1) Inserted
references to the Federal Register
documents seeking nominations for the
bulk drug substances and difficult-tocompound lists under section 503A (78
FR 72841, December 4, 2013, and 78 FR
72840, December 4, 2013, respectively);
(2) modified the language that discusses
the time period during which the MOU
will be made available to the States for
their consideration and signature and
the time period with regard to the
enforcement of the 5 percent limit if a
State chooses not to sign the MOU; and
(3) made grammatical and other minor
editorial changes for clarity.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking regarding section 503A
of the FD&C Act and human drug
compounding. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
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]]>Agencies
[Federal Register Volume 79, Number 127 (Wednesday, July 2, 2014)]
[Notices]
[Pages 37741-37742]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15522]
[[Page 37741]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Advisory Board on Radiation and Worker Health (ABRWH or Advisory
Board), National Institute for Occupational Safety and Health (NIOSH)
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), and pursuant to the requirements of 42
CFR 83.15(a), the Centers for Disease Control and Prevention (CDC),
announces the following meeting of the aforementioned committee:
Board Public Meeting Time and Date (All times are Mountain Time):
8:15 a.m.-5:30 p.m., July 29, 2014
Public Comment Time and Date (All times are Mountain Time):
5:30 p.m.-6:30 p.m.*, July 29, 2014
*Please note that the public comment periods may end before the
times indicated, following the last call for comments. Members of the
public who wish to provide public comments should plan to attend public
comment sessions at the start times listed.
Place: Hotel On The Falls, 475 River Parkway, Idaho Falls, Idaho
83402; Phone: (208) 523-8000; Fax: (208) 529-9610. Audio Conference
Call via FTS Conferencing. The USA toll-free, dial-in number is 1-866-
659-0537 with a pass code of 9933701. Live Meeting CONNECTION: https://www.livemeeting.com/cc/cdc/join?id=988QJ4&role=attend&pw=ABRWH; Meeting
ID: 988QJ4; Entry Code: ABRWH
Status: Open to the public, limited only by the space available.
The meeting space accommodates approximately 100 people.
Background: The Advisory Board was established under the Energy
Employees Occupational Illness Compensation Program Act of 2000 to
advise the President on a variety of policy and technical functions
required to implement and effectively manage the new compensation
program. Key functions of the Advisory Board include providing advice
on the development of probability of causation guidelines which have
been promulgated by the Department of Health and Human Services (HHS)
as a final rule, advice on methods of dose reconstruction which have
also been promulgated by HHS as a final rule, advice on the scientific
validity and quality of dose estimation and reconstruction efforts
being performed for purposes of the compensation program, and advice on
petitions to add classes of workers to the Special Exposure Cohort
(SEC).
In December 2000, the President delegated responsibility for
funding, staffing, and operating the Advisory Board to HHS, which
subsequently delegated this authority to the CDC. NIOSH implements this
responsibility for CDC. The charter was issued on August 3, 2001,
renewed at appropriate intervals, and will expire on August 3, 2015.
Purpose: This Advisory Board is charged with a) providing advice to
the Secretary, HHS, on the development of guidelines under Executive
Order 13179; b) providing advice to the Secretary, HHS, on the
scientific validity and quality of dose reconstruction efforts
performed for this program; and c) upon request by the Secretary, HHS,
advising the Secretary on whether there is a class of employees at any
Department of Energy facility who were exposed to radiation but for
whom it is not feasible to estimate their radiation dose, and on
whether there is reasonable likelihood that such radiation doses may
have endangered the health of members of this class.
Matters for Discussion: The agenda for the Advisory Board meeting
includes: NIOSH Program Update; Department of Labor Program Update;
Department of Energy Program Update; SEC petitions for: General Atomics
(La Jolla, CA), and Simonds Saw and Steel (Lockport, NY); SEC Issues
Work Group Report on ``Sufficient Accuracy''/Co-Worker Dose Modeling;
Worker Outreach Work Group Report; SEC Petitions Update; and Board Work
Session.
The agenda is subject to change as priorities dictate.
In the event an individual cannot attend, written comments may be
submitted in accordance with the redaction policy provided below. Any
written comments received will be provided at the meeting and should be
submitted to the contact person below well in advance of the meeting.
Policy on Redaction of Board Meeting Transcripts (Public Comment):
(1) If a person making a comment gives his or her personal information,
no attempt will be made to redact the name; however, NIOSH will redact
other personally identifiable information, such as contact information,
social security numbers, case numbers, etc., of the commenter. (2) If
an individual in making a statement reveals personal information (e.g.,
medical or employment information) about themselves that information
will not usually be redacted. The NIOSH Freedom of Information Act
(FOIA) coordinator will, however, review such revelations in accordance
with the Federal Advisory Committee Act and if deemed appropriate, will
redact such information. (3) If a commenter reveals personal
information concerning a living third party, that information will be
reviewed by the NIOSH FOIA coordinator, and upon determination, if
deemed appropriated, such information will be redacted, unless the
disclosure is made by the third party's authorized representative under
the Energy Employees Occupational Illness Compensation Program Act
(EEOICPA) program. (4) In general, information concerning a deceased
third party may be disclosed; however, such information will be
redacted if (a) the disclosure is made by an individual other than the
survivor claimant, a parent, spouse, or child, or the authorized
representative of the deceased third party; (b) if it is unclear
whether the third party is living or deceased; or (c) the information
is unrelated or irrelevant to the purpose of the disclosure. (5) The
Board will take reasonable steps to ensure that individuals making
public comment are aware of the fact that their comments (including
their name, if provided) will appear in a transcript of the meeting
posted on a public Web site. Such reasonable steps include: (a) A
statement read at the start of each public comment period stating that
transcripts will be posted and names of speakers will not be redacted;
(b) A printed copy of the statement mentioned in (a) above will be
displayed on the table where individuals sign up to make public
comments; (c) A statement such as outlined in (a) above will also
appear with the agenda for a Board Meeting when it is posted on the
NIOSH Web site; (d) A statement such as in (a) above will appear in the
Federal Register Notice that announces Board and Subcommittee meetings.
Contact Person For More Information: Theodore Katz, Designated
Federal Officer, NIOSH, CDC, 1600 Clifton Road NE., MS E-20, Atlanta,
Georgia 30333, telephone: (513) 533-6800, toll free: 1-800-CDC-INFO,
email: dcas@cdc.gov.
The Director, Management Analysis and Services Office, has been
delegated the authority to sign Federal Register Notices pertaining to
announcements of meetings and other committee management activities,
for both the Centers for Disease Control and
[[Page 37742]]
Prevention and the Agency for Toxic Substances and Disease Registry.
Gary Johnson,
Acting Director, Management Analysis and Services Office Centers for
Disease Control and Prevention.
[FR Doc. 2014-15522 Filed 7-1-14; 8:45 am]
BILLING CODE 4163-18-P
