Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping and Records Access Requirements for Food Facilities, 65033-65034 [E7-22480]
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65033
Federal Register / Vol. 72, No. 222 / Monday, November 19, 2007 / Notices
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–6974. Written
comments should be received within 30
days of this notice.
Proposed Project
Qualitative Evaluation of HIV
Counseling, Testing, and Referral
Services in Non-Health Care Settings:
Eliciting Consumer Views—New—
National Center for HIV/AIDS, Viral
Hepatitis, STD, and TB Prevention
(NCHHSTP), Coordinating Center for
Infectious Diseases (CCID), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Historically, HIV prevention efforts
have targeted people at risk for HIV
infection with the goal of keeping those
who are HIV negative from becoming
infected. However, the epidemic has
changed with the introduction of highly
active anti-retroviral therapy (HAART).
People with HIV are now living longer,
and with a steady incidence and
increasing prevalence, an estimated
1,039,000 to 1,185,000 people are now
living with HIV/AIDS in the United
States. It is estimated that 25% of HIVinfected persons are not aware of their
infection. Critical components in
controlling the spread of HIV infection
are early knowledge of HIV infection
and access to treatment. Awareness of
HIV infection has also been shown to
reduce high risk sexual behaviors in
some populations. Therefore, access to
HIV counseling, testing, and referral
(CTR) services can play a significant
role in reducing HIV transmission.
This project involves formative
research to elicit consumer opinions on
HIV CTR in non-health care settings.
The study entails conducting 21 focus
groups with persons who are either HIV
positive or at risk for HIV because of
their drug injection or sexual behavior.
The purpose of the focus groups is to
explore: (1) Facilitators and barriers to
use CTR services in non-health care
settings; (2) ideal service components to
decrease barriers to early diagnosis,
decrease risk behaviors, link clients
with follow-up care, and ensure client
rights; (3) perceived risks and benefits of
CTR; and (4) preferences for providing
informed consent.
CDC will use study findings to inform
the development of new
recommendations for HIV CTR in nonhealth care settings. We expect a total of
630 individuals to be screened for
eligibility. Of those who are screened,
we expect that 252 individuals will join
the study and participate in a focus
group. There are no costs to the
respondents other than their time. The
total estimated annual burden hours are
714.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Prospective Participant .............................
Adult Past Clients (HIV-negative) .............
Screener ...................................................
Facilitator Guide—Adult Past Clients
(HIV-negative).
Facilitator Guide—Adult Past Clients
(HIV-positive).
Facilitator Guide—Adult Potential Clients
Facilitator Guide—Adolescents (HIV-positive).
Facilitator Guide Adolescents (HIV-negative).
Adult Past Clients (HIV-positive) ..............
Adult Potential Clients ..............................
Adolescents (HIV-positive) .......................
Adolescents (HIV-negative) ......................
Dated: November 8, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–22637 Filed 11–16–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0444]
rwilkins on PROD1PC63 with NOTICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Recordkeeping
and Records Access Requirements for
Food Facilities
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
VerDate Aug<31>2005
20:17 Nov 16, 2007
Jkt 214001
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 information collection provisions of
FDA’s recordkeeping and records access
requirements for food facilities.
DATES: Submit written or electronic
comments on the collection of
information by January 18, 2008.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments or https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
PO 00000
Frm 00048
Fmt 4703
Number
responses per
respondent
Number of
respondents
Type of respondent
Sfmt 4703
Average burden
per response
(in hours)
630
60
1
1
20/60
2
60
1
2
60
24
1
1
2
2
48
1
2
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 the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\19NON1.SGM
19NON1
65034
Federal Register / Vol. 72, No. 222 / Monday, November 19, 2007 / Notices
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
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.
Recordkeeping and Records Access
Requirements for Food Facilities—21
CFR 1.337, 1.345, and 1.352 (OMB
Control Number 0910–0560)—Extension
The Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism
Act) added section 414 of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 350c), which requires that
persons who manufacture, process,
pack, hold, receive, distribute, transport,
or import food in the United States
establish and maintain records
identifying the immediate previous
sources and immediate subsequent
recipients of food. Sections 1.326
through 1.363 (21 CFR 1.326 through
1.363) of FDA’s regulations set forth the
requirements for recordkeeping and
records access. The requirement to
establish and maintain records improves
FDA’s ability to respond to, and further
contain, threats of serious adverse
health consequences or death to humans
or animals from accidental or deliberate
contamination of food.
Description of Respondents: Persons
that manufacture, process, pack, hold,
receive, distribute, transport, or import
food in the United States are required to
establish and maintain records,
including persons that engage in both
interstate and intrastate commerce.
FDA’s regulations require that records
for non-transporters include the name
and full contact information of sources,
recipients, and transporters, an adequate
description of the food including the
quantity and packaging, and the receipt
and shipping dates (§§ 1.337 and 1.345).
Required records for transporters
include the names of consignor and
consignee, points of origin and
destination, date of shipment, number
of packages, description of freight, route
of movement and name of each carrier
participating in the transportation, and
transfer points through which shipment
moved (§ 1.352). Existing records may
be used if they contain all of the
required information and are retained
for the required time period.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR Section
No. of
Recordkeepers
Annual Frequency
of Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
1.337, 1.345, and 1.352
(records maintenance)
379,493
1
379,493
13.228
5,020,000
1.337, 1.345, and 1.352
(learning for new firms)
18,975
1
18,975
4.790
90,890
Total
rwilkins on PROD1PC63 with NOTICES
1 There
5,110,890
are no capital costs or operating and maintenance costs associated with this collection of information.
This estimate is based on FDA’s
estimate of the number of facilities
affected by the final rule entitled
‘‘Establishment and Maintenance of
Records Under the Public Health
Security and Bioterrorism Preparedness
and Response Act of 2002,’’ published
in the Federal Register of December 9,
2004 (69 FR 71562 at 71630). With
regard to records maintenance, FDA
estimates that approximately 379,493
facilities will spend 13.228 hours
collecting, recording, and checking for
accuracy of the limited amount of
additional information required by the
regulations, for a total of 5,020,000
hours annually. In addition, FDA
estimates that new firms entering the
affected businesses will incur a burden
from learning the regulatory
requirements and understanding the
records required for compliance. In this
regard, the agency estimates the number
of new firms entering the affected
VerDate Aug<31>2005
20:17 Nov 16, 2007
Jkt 214001
businesses to be five percent (5%) of
379,493, or 18,975 firms. Thus, FDA
estimates that approximately 18,975
facilities will spend 4.790 hours
learning about the recordkeeping and
records access requirements, for a total
of 90,890 hours annually. Therefore, the
total annual recordkeeping burden is
estimated to be 5,110,890 hours.
Dated: November 13, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–22480 Filed 11–16–07; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 1999D–2013]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Draft Guidance for
Industry: Cooperative Manufacturing
Arrangements for Licensed Biologics
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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.
Frm 00049
Fmt 4703
Sfmt 4703
E:\FR\FM\19NON1.SGM
19NON1
]]>Agencies
[Federal Register Volume 72, Number 222 (Monday, November 19, 2007)]
[Notices]
[Pages 65033-65034]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-22480]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0444]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Recordkeeping and Records Access Requirements for Food
Facilities
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 information collection
provisions of FDA's recordkeeping and records access requirements for
food facilities.
DATES: Submit written or electronic comments on the collection of
information by January 18, 2008.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments or https://www.regulations.gov.
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 the Chief
Information Officer (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
[[Page 65034]]
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 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.
Recordkeeping and Records Access Requirements for Food Facilities--21
CFR 1.337, 1.345, and 1.352 (OMB Control Number 0910-0560)--Extension
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism Act) added section 414 of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350c), which
requires that persons who manufacture, process, pack, hold, receive,
distribute, transport, or import food in the United States establish
and maintain records identifying the immediate previous sources and
immediate subsequent recipients of food. Sections 1.326 through 1.363
(21 CFR 1.326 through 1.363) of FDA's regulations set forth the
requirements for recordkeeping and records access. The requirement to
establish and maintain records improves FDA's ability to respond to,
and further contain, threats of serious adverse health consequences or
death to humans or animals from accidental or deliberate contamination
of food.
Description of Respondents: Persons that manufacture, process,
pack, hold, receive, distribute, transport, or import food in the
United States are required to establish and maintain records, including
persons that engage in both interstate and intrastate commerce.
FDA's regulations require that records for non-transporters include
the name and full contact information of sources, recipients, and
transporters, an adequate description of the food including the
quantity and packaging, and the receipt and shipping dates (Sec. Sec.
1.337 and 1.345). Required records for transporters include the names
of consignor and consignee, points of origin and destination, date of
shipment, number of packages, description of freight, route of movement
and name of each carrier participating in the transportation, and
transfer points through which shipment moved (Sec. 1.352). Existing
records may be used if they contain all of the required information and
are retained for the required time period.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency of Total Annual
21 CFR Section Recordkeepers Recordkeeping Records Hours per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.337, 1.345, and 1.352 (records maintenance) 379,493 1 379,493 13.228 5,020,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.337, 1.345, and 1.352 (learning for new firms) 18,975 1 18,975 4.790 90,890
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 5,110,890
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
This estimate is based on FDA's estimate of the number of
facilities affected by the final rule entitled ``Establishment and
Maintenance of Records Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002,'' published in the
Federal Register of December 9, 2004 (69 FR 71562 at 71630). With
regard to records maintenance, FDA estimates that approximately 379,493
facilities will spend 13.228 hours collecting, recording, and checking
for accuracy of the limited amount of additional information required
by the regulations, for a total of 5,020,000 hours annually. In
addition, FDA estimates that new firms entering the affected businesses
will incur a burden from learning the regulatory requirements and
understanding the records required for compliance. In this regard, the
agency estimates the number of new firms entering the affected
businesses to be five percent (5%) of 379,493, or 18,975 firms. Thus,
FDA estimates that approximately 18,975 facilities will spend 4.790
hours learning about the recordkeeping and records access requirements,
for a total of 90,890 hours annually. Therefore, the total annual
---------------------------------------------------------------------------
recordkeeping burden is estimated to be 5,110,890 hours.
Dated: November 13, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-22480 Filed 11-16-07; 8:45 am]
BILLING CODE 4160-01-S
