Agency Information Collection Activities; Proposed Collection; Comment Request; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions, 69574-69576 [05-22668]
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69574
Federal Register / Vol. 70, No. 220 / Wednesday, November 16, 2005 / Notices
enrollees could, because of the small
size, use this information to deduce the
identity of the beneficiary).
POLICIES AND PRACTICES FOR STORING,
RETRIEVING, ACCESSING, RETAINING, AND
DISPOSING OF RECORDS IN THE SYSTEM:
SYSTEM MANAGER AND ADDRESS:
STORAGE:
All records are stored electronically.
Some input may be generated in
hardcopy, such as eligibility,
enrollment, or other health insurance
information before transcription to
electronic media.
RETRIEVABILITY:
The collected data are retrieved by an
individual identifier; e.g., beneficiary
name or HIC number.
SAFEGUARDS:
CMS has safeguards in place for
authorized users and monitors such
users to ensure against excessive or
unauthorized use. Personnel having
access to the system have been trained
in the Privacy Act and information
security requirements. Employees who
maintain records in this system are
instructed not to release data until the
intended recipient agrees to implement
appropriate management, operational
and technical safeguards sufficient to
protect the confidentiality, integrity and
availability of the information and
information systems and to prevent
unauthorized access.
This system will conform to all
applicable Federal laws and regulations
and Federal, HHS, and CMS policies
and standards as they relate to
information security and data privacy.
These laws and regulations include but
are not limited to: the Privacy Act of
1974; the Federal Information Security
Management Act of 2002; the Computer
Fraud and Abuse Act of 1986; the
Health Insurance Portability and
Accountability Act of 1996; the EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare
Modernization Act of 2003, and the
corresponding implementing
regulations. OMB Circular A–130,
Management of Federal Resources,
Appendix III, Security of Federal
Automated Information Resources also
applies. Federal, HHS, and CMS
policies and standards include but are
not limited to: all pertinent National
Institute of Standards and Technology
publications; the HHS Information
Systems Program Handbook and the
CMS Information Security Handbook.
CMS will retain information for a total
period not to exceed 25 years. Data
residing with the TrOOP facilitation
13:56 Nov 15, 2005
Henry Chao, Manager, Immediate
Office of the Director, Office of
Information Services, CMS, Room N3–
19–23, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850.
NOTIFICATION PROCEDURE:
For the purpose of access, the subject
individual should write to the system
manager who will require the system
name, address, age, gender type, and, for
verification purposes, the subject
individual’s name (woman’s maiden
name, if applicable).
RECORD ACCESS PROCEDURE:
For the purpose of access, use the
same procedures outlined in
Notification Procedures above.
Requestors should also reasonably
specify the record contents being
sought. (These procedures are in
accordance with Department regulation
45 CFR, parts 160, 162, and 164.)
CONTESTING RECORDS PROCEDURES:
The subject individual should contact
the system manager named above and
reasonably identify the records and
specify the information to be contested.
State the corrective action sought and
the reasons for the correction with
supporting justification. (These
procedures are in accordance with
Department regulation 45 CFR 5b.7).
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
None.
[FR Doc. 05–22657 Filed 11–15–05; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0425]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; General
Administrative Procedures: Citizen
Petitions; Petition for Reconsideration
or Stay of Action; Advisory Opinions
AGENCY:
Jkt 208001
Food and Drug Administration,
HHS.
ACTION:
RETENTION AND DISPOSAL:
VerDate Aug<31>2005
contractor site agent shall be returned to
CMS at the end of the contract period,
with all data then being the
responsibility of CMS for adequate
storage and security.
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
PO 00000
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Sfmt 4703
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the reporting requirements contained in
existing FDA regulations regarding the
general administrative procedures for a
person to take the following actions:
Petition the Commissioner of Food and
Drugs (the Commissioner) to issue,
amend, or revoke a rule; file a petition
for an administrative reconsideration or
an administrative stay of action; and
request an advisory opinion from the
Commissioner.
DATES: Submit written or electronic
comments on the collection of
information by January 17, 2006.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
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Federal Register / Vol. 70, No. 220 / Wednesday, November 16, 2005 / Notices
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
General Administrative Procedures:
Citizen Petitions; Petition for
Reconsideration or Stay of Action;
Advisory Opinions—(21 CFR Part 10)
(OMB Control Number 0910–0183)—
Extension
The Administrative Procedures Act (5
U.S.C. 553(e)), provides that every
agency shall give an interested person
the right to petition for issuance,
amendment, or repeal of a rule. Under
part 10 (21 CFR part 10), § 10.30 sets
forth the format and procedures by
which an interested person may submit
to FDA, in accordance with § 10.20
(submission of documents to the
Division of Dockets Management), a
citizen petition requesting the
Commissioner to issue, amend, or
revoke a regulation or order, or to take
or refrain from taking any other form of
administrative action.
The Commissioner may grant or deny
such a petition, in whole or in part, and
may grant such other relief or take other
action as the petition warrants.
Respondents are individuals or
households, State or local governments,
not-for-profit institutions, and
businesses or other for-profit
institutions or groups.
Section 10.33, issued under section
701(a) of the Federal, Food, Drug, and
Cosmetic Act (the act) (21 U.S.C.
371(a)), sets forth the format and
procedures by which an interested
person may request reconsideration of
part or all of a decision of the
Commissioner in a petition submitted
under § 10.25 (initiation of
administrative proceedings). A petition
for reconsideration must contain in a
well-organized format a full statement of
the factual and legal grounds upon
which the petition relies. The grounds
must demonstrate that relevant
information and views contained in the
administrative record were not
previously or not adequately considered
by the Commissioner. The respondent
must submit a petition no later than 30
days after the decision has been made.
However, the Commissioner may, for
good cause, permit a petition to be filed
after 30 days. An interested person who
wishes to rely on information or views
not included in the administrative
record shall submit them with a new
petition to modify the decision. FDA
uses the information provided in the
request to determine whether to grant
the petition for reconsideration.
Respondents to this collection of
information are individuals or
households, State or local governments,
not-for-profit institutions, and
businesses or other for-profit
institutions who are requesting a
reconsideration of a matter from the
Commissioner.
Section 10.35, issued under section
701(a) of the act, sets forth the format
69575
and procedures by which an interested
person may request, in accordance with
§ 10.20 (submission of documents to
Division of Dockets Management), the
Commissioner to stay the effective date
of any administrative action.
Such a petition must provide the
following information: (1) The decision
involved; (2) the action requested,
including the length of time for which
a stay is requested; and (3) a statement
of the factual and legal grounds on
which the interested person relies in
seeking the stay. FDA uses the
information provided in the request to
determine whether to grant the petition
for a stay of action. Respondents to this
information collection are interested
persons who choose to file a petition for
an administrative stay of action.
Section 10.85, issued under section
701(a) of the act, sets forth the format
and procedures by which an interested
person may request, in accordance with
§ 10.20 (submission of documents to the
Division of Dockets Management), an
advisory opinion from the
Commissioner on a matter of general
applicability. An advisory opinion
represents the formal position of FDA
on a matter of general applicability.
When making a request, the petitioner
must provide a concise statement of the
issues and questions on which an
opinion is requested, and a full
statement of the facts and legal points
relevant to the request. Respondents to
this collection of information are
interested persons seeking an advisory
opinion from the Commissioner on the
agency’s formal position for matters of
general applicability.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
10.30
156
3
468
12
5,616
10.33
10
2
20
10
200
10.35
13
2
26
10
260
10.85
2
1
2
16
32
Total
1There
6,108
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimates for this
collection of information are based on
agency records and experience over the
past 3 years. Agency personnel handling
the petitions regarding § 10.30 received
approximately 156 citizen petitions
VerDate Aug<31>2005
13:56 Nov 15, 2005
Jkt 208001
annually, each required an average of 12
hours of preparation time. The agency
received approximately 10 requests
annually regarding § 10.33
(administrative reconsideration of an
action), each required an average of 10
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Fmt 4703
Sfmt 4703
hours of preparation time. Regarding
§ 10.35 (administrative stay of an
action), the agency received
approximately 13 requests annually,
each required an average of 10 hours of
preparation time. Lastly, regarding
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69576
Federal Register / Vol. 70, No. 220 / Wednesday, November 16, 2005 / Notices
petitions for § 10.85 (advisory opinions),
the agency received approximately 2
requests annually, each required an
average of 16 hours of preparation time.
Dated: November 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–22668 Filed 11–15–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0290]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Importer’s Entry
Notice
AGENCY:
Food and Drug Administration,
HHS.
Notice.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by December
16, 2005.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. To ensure that comments on
the information collection are received,
OMB recommends that comments be
faxed to the Office of Information and
Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Importer’s Entry Notice—(OMB Control
Number 0910–0046)—Extension
Section 801 of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
381) charges FDA with the following
responsibilities: (1) Ensuring that
foreign-origin FDA-regulated foods,
drugs, cosmetics, medical devices, and
radiological health products offered for
import into the United States meet the
same requirements of the act as do
domestic products; and (2) preventing
shipments from entering the country if
they are not in compliance.
The information collected by FDA
consists of the following: (1) Product
code, an alpha-numeric series of
characters that identifies each product
FDA regulates; (2) FDA country of
origin, the country where the FDAregistered or FDA-responsible firm is
located; (3) FDA manufacturer, the party
who manufactured, grew, assembled, or
otherwise processed the goods (if more
than one, the last party who
substantially transformed the product);
(4) shipper, the party responsible for
packing, consolidating, or arranging the
shipment of goods to their final
destinations; (5) quantity and value of
the shipment; and (6) if appropriate,
affirmation of compliance, a code that
conveys specific FDA information, such
as registration number, foreign
government certification, etc. This
information is collected electronically
by the entry filer via the U.S. Customs
Service’s Automated Commercial
System at the same time that person
files an entry for import with the U.S.
Custom Service. FDA uses this
information to make admissibility
decisions about FDA-regulated products
offered for import into the United
States.
The annual reporting burden is
derived from the basic processes and
procedures used in fiscal year (FY)
1995. The total number of entries
submitted to the automated system in
FY 2004 was 6,626,827. The total
number of entries less the disclaimer
entries will represent the total FDA
products entered into the automated
system. A total of 53 percent of all
entries entered into the automated
system were entries dealing with FDAregulated products. The number of
respondents is a count of filers who
submit entry data for foreign-origin
FDA-regulated products. The estimated
reporting burden is based on
information obtained by FDA while
contacting potential respondents.
Disclaimer entries are not FDA
commodities.
In the Federal Register of August 3,
2005 (70 FR 44656), FDA published a
60-day notice requesting public
comment on the information collection
provisions. One comment was received.
The Government of Canada is
concerned that the methodology used
does not take into consideration the
additional burden of FDA’s interim final
prior notice and regulation rules which
came into effect December 2003. They
urged FDA to amend the methodology
used to take into consideration the
additional burden associated with all
requirements for providing information
concerning foreign-origin FDA-regulated
foods. Of particular concern is the
burden resulting from the
implementation of the prior notice and
regulation rules under the Public Health
Security and Bioterrorism Preparedness
and Response Act of 2002.
The burden for the prior notice and
regulation rules is reported and
approved under OMB Control Number
0910–0520; expiration date October 31,
2006.
FDA estimates the burden of the
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 U.S.C. Section
No. of
Respondents
801
1There
Annual Frequency
per Response
3,406
1,089
Total Annual
Responses
Hours per
Response
3,709,134
.14
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Aug<31>2005
13:56 Nov 15, 2005
Jkt 208001
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Frm 00069
Fmt 4703
Sfmt 4703
E:\FR\FM\16NON1.SGM
Total Hours
16NON1
519,279
]]>Agencies
[Federal Register Volume 70, Number 220 (Wednesday, November 16, 2005)]
[Notices]
[Pages 69574-69576]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-22668]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0425]
Agency Information Collection Activities; Proposed Collection;
Comment Request; General Administrative Procedures: Citizen Petitions;
Petition for Reconsideration or Stay of Action; Advisory Opinions
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the reporting requirements
contained in existing FDA regulations regarding the general
administrative procedures for a person to take the following actions:
Petition the Commissioner of Food and Drugs (the Commissioner) to
issue, amend, or revoke a rule; file a petition for an administrative
reconsideration or an administrative stay of action; and request an
advisory opinion from the Commissioner.
DATES: Submit written or electronic comments on the collection of
information by January 17, 2006.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. Submit written comments on
the collection of information to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4659.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites
[[Page 69575]]
comments on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
General Administrative Procedures: Citizen Petitions; Petition for
Reconsideration or Stay of Action; Advisory Opinions--(21 CFR Part 10)
(OMB Control Number 0910-0183)--Extension
The Administrative Procedures Act (5 U.S.C. 553(e)), provides that
every agency shall give an interested person the right to petition for
issuance, amendment, or repeal of a rule. Under part 10 (21 CFR part
10), Sec. 10.30 sets forth the format and procedures by which an
interested person may submit to FDA, in accordance with Sec. 10.20
(submission of documents to the Division of Dockets Management), a
citizen petition requesting the Commissioner to issue, amend, or revoke
a regulation or order, or to take or refrain from taking any other form
of administrative action.
The Commissioner may grant or deny such a petition, in whole or in
part, and may grant such other relief or take other action as the
petition warrants. Respondents are individuals or households, State or
local governments, not-for-profit institutions, and businesses or other
for-profit institutions or groups.
Section 10.33, issued under section 701(a) of the Federal, Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 371(a)), sets forth the
format and procedures by which an interested person may request
reconsideration of part or all of a decision of the Commissioner in a
petition submitted under Sec. 10.25 (initiation of administrative
proceedings). A petition for reconsideration must contain in a well-
organized format a full statement of the factual and legal grounds upon
which the petition relies. The grounds must demonstrate that relevant
information and views contained in the administrative record were not
previously or not adequately considered by the Commissioner. The
respondent must submit a petition no later than 30 days after the
decision has been made. However, the Commissioner may, for good cause,
permit a petition to be filed after 30 days. An interested person who
wishes to rely on information or views not included in the
administrative record shall submit them with a new petition to modify
the decision. FDA uses the information provided in the request to
determine whether to grant the petition for reconsideration.
Respondents to this collection of information are individuals or
households, State or local governments, not-for-profit institutions,
and businesses or other for-profit institutions who are requesting a
reconsideration of a matter from the Commissioner.
Section 10.35, issued under section 701(a) of the act, sets forth
the format and procedures by which an interested person may request, in
accordance with Sec. 10.20 (submission of documents to Division of
Dockets Management), the Commissioner to stay the effective date of any
administrative action.
Such a petition must provide the following information: (1) The
decision involved; (2) the action requested, including the length of
time for which a stay is requested; and (3) a statement of the factual
and legal grounds on which the interested person relies in seeking the
stay. FDA uses the information provided in the request to determine
whether to grant the petition for a stay of action. Respondents to this
information collection are interested persons who choose to file a
petition for an administrative stay of action.
Section 10.85, issued under section 701(a) of the act, sets forth
the format and procedures by which an interested person may request, in
accordance with Sec. 10.20 (submission of documents to the Division of
Dockets Management), an advisory opinion from the Commissioner on a
matter of general applicability. An advisory opinion represents the
formal position of FDA on a matter of general applicability. When
making a request, the petitioner must provide a concise statement of
the issues and questions on which an opinion is requested, and a full
statement of the facts and legal points relevant to the request.
Respondents to this collection of information are interested persons
seeking an advisory opinion from the Commissioner on the agency's
formal position for matters of general applicability.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
10.30 156 3 468 12 5,616
--------------------------------------------------------------------------------------------------------------------------------------------------------
10.33 10 2 20 10 200
--------------------------------------------------------------------------------------------------------------------------------------------------------
10.35 13 2 26 10 260
--------------------------------------------------------------------------------------------------------------------------------------------------------
10.85 2 1 2 16 32
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 6,108
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimates for this collection of information are based
on agency records and experience over the past 3 years. Agency
personnel handling the petitions regarding Sec. 10.30 received
approximately 156 citizen petitions annually, each required an average
of 12 hours of preparation time. The agency received approximately 10
requests annually regarding Sec. 10.33 (administrative reconsideration
of an action), each required an average of 10 hours of preparation
time. Regarding Sec. 10.35 (administrative stay of an action), the
agency received approximately 13 requests annually, each required an
average of 10 hours of preparation time. Lastly, regarding
[[Page 69576]]
petitions for Sec. 10.85 (advisory opinions), the agency received
approximately 2 requests annually, each required an average of 16 hours
of preparation time.
Dated: November 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-22668 Filed 11-15-05; 8:45 am]
BILLING CODE 4160-01-S
