Food and Drug Administration-Regulated Products Containing Nanotechnology Materials; Planning of Public Meeting, 19523-19524 [E6-5526]
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Federal Register / Vol. 71, No. 72 / Friday, April 14, 2006 / Notices
and Not-for-profit institutions; Number
of Respondents: 2,458,549; Total
Annual Responses: 981,642; Total
Annual Hours: 547,578.
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Information
Collection Requirements in 42 CFR
478.18, 478.34, 478.36, 478.42, QIO
Reconsiderations and Appeals; Use: In
the event that a beneficiary, provider,
physician, or other practitioner does not
agree with the initial determination of a
Quality Improvement Organization
(QIO) or a QIO subcontractor, it is
within that party’s rights to request
reconsideration. The information
collection requirements 42 CFR 478.18,
478.34, 478.36, and 478.42, contain
procedures for QIOs to use in
reconsideration of initial
determinations. The information
requirements contained in these
regulations are on QIOs to provide
information to parties requesting the
reconsideration. These parties will use
the information as guidelines for appeal
rights in instances where issues are
actively being disputed.; Form Number:
CMS–R–72 (OMB#: 0938–0443);
Frequency: Reporting—On occasion;
Affected Public: Individuals or
Households and Business or other forprofit institutions; Number of
Respondents: 2,590; Total Annual
Responses: 5,228; Total Annual Hours:
2,822.
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Certification
Statement for Electronic File
Interchange Organizations (EFIOS) that
Submit National Provider Identifier
(NPI) Data to the National Plan and
Enumeration System; Use: The EFI
process is designed to allow
organizations to submit NPI application
information for large numbers of
providers in a single file. Once it has
obtained and formatted the necessary
provider data, the EFIO will
electronically submit the file to NPPES
for processing. As each file can contain
up to approximately 100,000 records, or
provider applications, the EFI process
greatly reduces the paperwork and
overall administrative burden associated
with enumerating providers; Form
Number: CMS–10175 (OMB#: 0938–
0984); Frequency: Reporting—Other,
One-time; Affected Public: Business or
other for-profit, and Not-for-profit
institutions; Number of Respondents:
1000; Total Annual Responses: 1000;
Total Annual Hours: 3000.
4. Type of Information Collection
Request: Extension of a currently
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16:37 Apr 13, 2006
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approved collection; Title of
Information Collection: Survey of Newly
Eligible Medicare Beneficiaries; Use:
CMS is responsible for providing
beneficiaries with the Medicare program
information they need to effectively
choose the health care plan best suited
to their needs. In order to provide such
information, CMS needs to know (1)
Whether or not new enrollees are aware
of the choices they have, (2) what
beneficiaries understand about the basic
elements of the Medicare program, (3)
what other sources currently provide
Medicare-related information, and (4)
how all of these items vary across
beneficiary subpopulations. To this end,
CMS must have the ability to measure
over time what beneficiaries know and
understand about the Medicare
program. Measuring beneficiaries’
information needs and knowledge over
time will help CMS evaluate its impact
on information/education, population
changes and other initiatives; Form
Number: CMS–10050 (OMB#: 0938–
0869); Frequency: Reporting—Quarterly;
Affected Public: Individuals or
Households; Number of Respondents:
2400; Total Annual Responses: 2400;
Total Annual Hours: 800.
5. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: SSO Report of
State Buy-in Problem and Supporting
Regulations in 42 CFR 407.40; Use:
Under the State Buy-In program, States
enroll certain groups of needy people
under the Part B Supplementary
Medical Insurance (SMI) Program and
pay their premiums. The purpose of the
‘‘buy-in’’ is to allow the States to
provide SMI protection to certain
groups of needy individuals as part of
its total assistance plan. Generally,
States ‘‘buy-in’’ for individuals who are
categorically needy under Medicaid and
meet the eligibility requirements for
Medicare Part B. States can also include
in their buy-in agreement those eligible
for medical assistance only. The CMS–
1957 is used in the resolution of
beneficiary complaints regarding State
buy-in. This form facilitates the
coordination of efforts between the SSO,
State Medicaid Agencies, and CMS in
the resolution of a beneficiary’s State
buy-in problem; Form Number: CMS–
1957 (OMB#: 0938–0035); Frequency:
Reporting—On occasion; Affected
Public: Federal government, Individuals
or Households, and State, Local, and
Tribal governments; Number of
Respondents: 6,600; Total Annual
Responses: 6,600; Total Annual Hours:
2,366.
6. Type of Information Collection
Request: Extension of a currently
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Frm 00048
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19523
approved collection; Title of
Information Collection: Home Health
Agency Survey and Deficiencies Report,
Home Health Functional Assessment
Instrument and Supporting Regulations
in 42 CFR 488.26 and 442.30; Use: In
order to participate in the Medicare
program as a Home Health Agency
(HHA) provider, the HHA must meet
Federal Standards. These forms used to
record information about patients’
health and provider compliance with
requirement and report information to
the Federal Government; Form Number:
CMS–1515 & 1572 (OMB#: 0938–0355);
Frequency: Reporting—Annually;
Affected Public: Business or other forprofit, Individuals or Households, and
Not-for-profit institutions; Number of
Respondents: 24,150; Total Annual
Responses: 24,150; Total Annual Hours:
3,864.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received at the address below, no
later than 5 p.m. on June 13, 2006.
CMS, Office of Strategic Operations
and Regulatory Affairs, Division of
Regulations Development—B, Attention:
William N. Parham, III, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: April 4, 2006.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E6–5408 Filed 4–13–06; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0107]
Food and Drug AdministrationRegulated Products Containing
Nanotechnology Materials; Planning of
Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\14APN1.SGM
Request for comments.
14APN1
19524
Federal Register / Vol. 71, No. 72 / Friday, April 14, 2006 / Notices
wwhite on PROD1PC65 with NOTICES
SUMMARY: The Food and Drug
Administration (FDA) is planning a
public meeting on FDA-regulated
products containing nanotechnology
materials. The purpose of the meeting
will be to help FDA further its
understanding of developments in
nanotechnology materials that pertain to
FDA-regulated products. FDA is
interested in learning about the kinds of
new nanotechnology material products
under development in the areas of foods
(including dietary supplements), food
and color additives, animal feeds,
cosmetics, drugs and biologics, and
medical devices; whether there are
scientific issues that should be
addressed; and any other issues about
which the regulated industry, academia
and the interested public may wish to
inform FDA concerning the use of
nanotechnology materials in FDAregulated products.
DATES AND TIMES: The public meeting
will be held in mid-October 2006.
Details on the date and time of the
meeting will be provided in a
subsequent Federal Register notice.
ADDRESSES: The public workshop will
be held in the Washington, DC
metropolitan area. The meeting address
will be provided in a subsequent
Federal Register notice and posted at
https://www.fda.gov/nanotechnology.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments
to https://www.fda.gov/dockets/
ecomments. All comments should be
identified with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
For information about this document:
Poppy Kendall, Food and Drug
Administration (HF–11), 5600
Fishers Lane, Rockville, MD 20857,
301–827–3360, FAX: 301–594–
6777, e-mail:
Poppy.Kendall@FDA.HHS.Gov.
SUPPLEMENTARY INFORMATION:
I. Why Are We Holding a Public
Meeting?
Nanotechnology is defined in a
variety of ways. The National
Nanotechnology Initiative (a U.S.
Government research and development
coordinating program) refers to
nanotechnology as ‘‘the understanding
and control of matter at dimensions of
roughly 1 to 100 nanometers, where
unique phenomena enable novel
applications’’ (https://www.nano.gov). A
nanometer is a billionth of a meter, and
is approximately the width of 10
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16:37 Apr 13, 2006
Jkt 208001
hydrogen atoms lined up side by side.
(A human hair is about 80,000
nanometers in width. Deoxyribonucleic
acid (DNA) is about 2.5 nanometers in
width.)
Due to their small size and extremely
high ratio of surface area to volume,
nanotechnology materials often have
chemical or physical properties that are
different from those of their larger
counterparts. Such differences include
altered magnetic properties, altered
electrical or optical activity, increased
structural integrity, and increased
chemical and biological activity.
Because of these properties,
nanotechnology materials have great
potential for use in a vast array of
products. Also because of some of their
special properties, they may pose
different safety issues than their larger
counterparts. Of particular interest to
FDA, nanotechnology materials may
enable new developments in implants
and prosthetics, drug delivery, and food
processing, and may already be in use
in some cosmetics and sunscreens. As
part of its critical path initiative, FDA is
interested in learning if there are
opportunities for it to help overcome
scientific hurdles that may be inhibiting
the use of nanotechnology in medical
product development.
We will be holding this meeting
because we are interested in learning
about the kinds of new nanotechnology
material products under development in
the areas of foods (including dietary
supplements), food and color additives,
animal feeds, cosmetics, drugs and
biologics, and medical devices; whether
there are scientific issues that should be
addressed; and any other issues about
which the regulated industry, academia
and the interested public may wish to
inform FDA concerning the use of
nanotechnology materials in FDAregulated products.
For more information about FDA’s
role regarding nanotechnology products,
see our Web page at https://www.fda.gov/
nanotechnology. We are announcing our
plans now to hold a meeting to give
ourselves and participants ample time
to prepare.
II. How Can You Participate?
Details on registration and the
meeting agenda will be provided in a
subsequent Federal Register notice and
at https://www.fda.gov/nanotechnology.
To help us plan the logistics and agenda
for the meeting, we would appreciate
receiving expressions of interest from
those planning on attending or
presenting at the meeting, via e-mail or
phone to Poppy Kendall (see FOR
FURTHER INFORMATION CONTACT). We will
attempt to obtain a venue and structure
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
the meeting to accommodate the level of
expressed interest and to address a
range of topics, but will not begin the
registration process until after
publication of the subsequent Federal
Register notice.
III. How Should You Send Comments
on the Issues?
Interested persons may submit written
or electronic comments to the Division
of Dockets Management (see
ADDRESSES). Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments are to be identified
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.
Dated: March 21, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–5526 Filed 4–13–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D–0206]
Guidance for Industry on Exocrine
Pancreatic Insufficiency Drug
Products—Submitting New Drug
Applications; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Exocrine Pancreatic
Insufficiency Drug Products—
Submitting NDAs.’’ This guidance is
intended to assist manufacturers of
exocrine pancreatic insufficiency drug
products in preparing and submitting
documentation to meet new drug
application (NDA) requirements for the
drug products.
DATES: Submit written or electronic
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one selfaddressed adhesive label to assist that
E:\FR\FM\14APN1.SGM
14APN1
]]>Agencies
[Federal Register Volume 71, Number 72 (Friday, April 14, 2006)]
[Notices]
[Pages 19523-19524]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-5526]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0107]
Food and Drug Administration-Regulated Products Containing
Nanotechnology Materials; Planning of Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Request for comments.
-----------------------------------------------------------------------
[[Page 19524]]
SUMMARY: The Food and Drug Administration (FDA) is planning a public
meeting on FDA-regulated products containing nanotechnology materials.
The purpose of the meeting will be to help FDA further its
understanding of developments in nanotechnology materials that pertain
to FDA-regulated products. FDA is interested in learning about the
kinds of new nanotechnology material products under development in the
areas of foods (including dietary supplements), food and color
additives, animal feeds, cosmetics, drugs and biologics, and medical
devices; whether there are scientific issues that should be addressed;
and any other issues about which the regulated industry, academia and
the interested public may wish to inform FDA concerning the use of
nanotechnology materials in FDA-regulated products.
DATES AND TIMES: The public meeting will be held in mid-October 2006.
Details on the date and time of the meeting will be provided in a
subsequent Federal Register notice.
ADDRESSES: The public workshop will be held in the Washington, DC
metropolitan area. The meeting address will be provided in a subsequent
Federal Register notice and posted at https://www.fda.gov/
nanotechnology.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to https://www.fda.gov/
dockets/ecomments. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
For information about this document: Poppy Kendall, Food and Drug
Administration (HF-11), 5600 Fishers Lane, Rockville, MD 20857, 301-
827-3360, FAX: 301-594-6777, e-mail: Poppy.Kendall@FDA.HHS.Gov.
SUPPLEMENTARY INFORMATION:
I. Why Are We Holding a Public Meeting?
Nanotechnology is defined in a variety of ways. The National
Nanotechnology Initiative (a U.S. Government research and development
coordinating program) refers to nanotechnology as ``the understanding
and control of matter at dimensions of roughly 1 to 100 nanometers,
where unique phenomena enable novel applications'' (https://
www.nano.gov). A nanometer is a billionth of a meter, and is
approximately the width of 10 hydrogen atoms lined up side by side. (A
human hair is about 80,000 nanometers in width. Deoxyribonucleic acid
(DNA) is about 2.5 nanometers in width.)
Due to their small size and extremely high ratio of surface area to
volume, nanotechnology materials often have chemical or physical
properties that are different from those of their larger counterparts.
Such differences include altered magnetic properties, altered
electrical or optical activity, increased structural integrity, and
increased chemical and biological activity. Because of these
properties, nanotechnology materials have great potential for use in a
vast array of products. Also because of some of their special
properties, they may pose different safety issues than their larger
counterparts. Of particular interest to FDA, nanotechnology materials
may enable new developments in implants and prosthetics, drug delivery,
and food processing, and may already be in use in some cosmetics and
sunscreens. As part of its critical path initiative, FDA is interested
in learning if there are opportunities for it to help overcome
scientific hurdles that may be inhibiting the use of nanotechnology in
medical product development.
We will be holding this meeting because we are interested in
learning about the kinds of new nanotechnology material products under
development in the areas of foods (including dietary supplements), food
and color additives, animal feeds, cosmetics, drugs and biologics, and
medical devices; whether there are scientific issues that should be
addressed; and any other issues about which the regulated industry,
academia and the interested public may wish to inform FDA concerning
the use of nanotechnology materials in FDA-regulated products.
For more information about FDA's role regarding nanotechnology
products, see our Web page at https://www.fda.gov/nanotechnology. We are
announcing our plans now to hold a meeting to give ourselves and
participants ample time to prepare.
II. How Can You Participate?
Details on registration and the meeting agenda will be provided in
a subsequent Federal Register notice and at https://www.fda.gov/
nanotechnology. To help us plan the logistics and agenda for the
meeting, we would appreciate receiving expressions of interest from
those planning on attending or presenting at the meeting, via e-mail or
phone to Poppy Kendall (see FOR FURTHER INFORMATION CONTACT). We will
attempt to obtain a venue and structure the meeting to accommodate the
level of expressed interest and to address a range of topics, but will
not begin the registration process until after publication of the
subsequent Federal Register notice.
III. How Should You Send Comments on the Issues?
Interested persons may submit written or electronic comments to the
Division of Dockets Management (see ADDRESSES). Submit a single copy of
electronic comments or two paper copies of any mailed comments, except
that individuals may submit one paper copy. Comments are to be
identified 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.
Dated: March 21, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-5526 Filed 4-13-06; 8:45 am]
BILLING CODE 4160-01-S
