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Federal Register / Vol. 67, No.

214 / Tuesday, November 5, 2002 / Notices 67411

SUMMARY: The Food and Drug cases to seize and destroy unsafe DEPARTMENT OF HEALTH AND
Administration (FDA) is announcing the imported products regulated by FDA. HUMAN SERVICES
availability of a draft procedural This draft guidance serves to delineate
guidance entitled ‘‘Guidance FDA’s responsibilities for collecting Indian Health Service
Concerning Recommending Customs’ information, analyzing public health
Seizure and Destruction of Imported Request for public comment: 60-day
risk, recommending seizure, and
Human and Animal Food That Has Not proposed information collection.
coordinating destruction of the violative
Been Reconditioned.’’ This draft imported food by Customs. The purpose AGENCY: Indian Health Service.
guidance will provide FDA field offices of this guidance is to ensure that
with procedures for recommending ACTION:Request for public comment: 60-
imported food that poses a significant day proposed information collection.
seizure and destruction of foods that
risk to public health is not distributed
pose a significant risk to public health. SUMMARY: The Indian Health Service
or exported and subsequently re-entered
DATES: Submit written or electronic (IHS), as part of its continuing effort to
into U.S. commerce.
comments on the draft guidance by reduce paperwork and respondent
January 6, 2003, to ensure adequate The draft guidance entitled burden, conducts a pre-clearance
consideration of the comments in the ‘‘Guidance Concerning Recommending consultation program to provide the
preparation of the final guidance. Customs’ Seizure and Destruction of general public and Federal agencies
However, you may submit written or Imported Human and Animal Food That with an opportunity to comment on
electronic comments at any time. Has Not Been Reconditioned’’ is level 1 proposed and/or continuing collections
ADDRESSES: Submit written requests for guidance that is being distributed for of information in accordance with the
single copies of the draft guidance to the comment in accordance with FDA’s Paperwork Reduction Act of 1995
Division of Import Operations and regulation on good guidance practices (PRA95) (44 U.S.C. 3506(c)(2)(A)). This
Policy (HFC–170), Food and Drug (21 CFR 10.115) relating to the program helps to ensure that requested
Administration, 5600 Fishers Lane, development, issuance, and use of data can be provided in the desired
Rockville, MD 20857. Send one self- guidance documents. The draft format, reporting burden (time and
addressed adhesive label to assist that guidance represents the agency’s current financial resources) is minimized,
office in processing your request. thinking on this topic. It does not create collection instruments are clearly
Submit written comments on the draft or confer any rights for, or on, any understood, and the impact of collection
guidance to Dockets Management person and does not operate to bind requirements on respondents can be
Branch (HFA–305), 5630 Fishers Lane, FDA or the public. An alternative properly assessed. Currently, the IHS is
rm. 1061, Rockville, MD, 20852. Submit approach may be used if such approach providing a 60-day advance opportunity
electronic comments to http:// satisfies the requirements of the for public comment on a proposed new
www.fda.gov/dockets/ecomments. See collection of information to be
applicable statutes and regulations.
the SUPPLEMENTARY INFORMATION section submitted to the Office of Management
for electronic access to the draft II. Comments and Budget for review.
guidance document. Proposed Collection: Title: 0917–
FOR FURTHER INFORMATION CONTACT: Interested persons may submit to the NEW, ‘‘IHS Forms to implement the
Joseph McCallion, Division of Import Dockets Management Branch (see Privacy Rule (45 CFR parts 160 and
Operations and Policy (HFC–170), Food ADDRESSES) written or electronic 164)’’. Type of Information Collection
and Drug Administration, 5600 Fishers comments on the draft guidance by Request: New collection. Form
Lane, Rockville, MD 20857, 301–443– January 6, 2003. Two copies of any Number(s): IHS–810, IHS–911, IHS–
6553, FAX 301–594–3787, email: comments are to be submitted, except 912–1, IHS 912–2, and IHS 913. Need
jmccalli@ora.fda.gov. that individuals may submit one copy. and Use of Information Collection: This
SUPPLEMENTARY INFORMATION:
Comments are to be identified with the collection of information is made
docket number found in brackets in the necessary by the Department of Health
I. Background heading of this document. A copy of the and Human Services Rule entitled
In July 1999, the Secretaries of Health draft guidance and received comments ‘‘Standards for Privacy of Individually
and Human Services and Treasury may be seen in the Dockets Management Identifiable Health Information’’
began development of new operational Branch between 9 a.m. and 4 p.m., (‘‘Privacy Rule’’) (45 CFR Parts 160 and
procedures to protect consumers from Monday through Friday. 164). The Privacy Rule implements the
unsafe imported food. A plan, privacy requirements of the
announced in December 1999, was III. Electronic Access Administrative Simplification subtitle
developed by FDA and the U.S. Persons with access to the Internet of the Health Information Portability
Customs Service (Customs) to prevent and Accountability Act of 1996 and
may obtain the document at http://
distribution of unsafe imported food by creates national standards to protect
www.cfsan.fda.gov/~dms/
destroying food products that pose a individual’s personal health information
guidance.html. and gives patients increased access to
significant risk to public health. This
initiative optimizes the statutory Dated: April 5, 2002. their medical records. Sections, 45 CFR
authorities and resources available to Margaret M. Dotzel, 164.508, 522, 526 and 528 of the Rule
FDA and Customs. Associate Commissioner for Policy. require the collection of information to
Food products refused entry into the [FR Doc. 02–27575 Filed 11–4–02; 8:45 am]
implement these protection standards
United States may be offered and access requirements. The IHS will
BILLING CODE 4160–01–S
subsequently for re-importation by use the following data collection
importers who choose to circumvent the instruments to implement the
import regulatory system or by information collection requirements
importers who are unaware of the contained in the Rule.
previous refusal. FDA and Customs 45 CFR 164.508: This provision
have worked together on numerous requires covered entities to obtain or

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67412 Federal Register / Vol. 67, No. 214 / Tuesday, November 5, 2002 / Notices

receive a valid authorization for its use restriction if the individual agrees to or Amendment of Protected Health
or disclosure of protected health requests the termination in writing. The Information’’ will be used to document
information for other than treatment, form ‘‘IHS–912–2 Request for an individual’s request to amend their
payment and healthcare operations. Revocation of Restriction(s)’’ will be protected health information and the
Under the provision individuals may used to document the agency or agency’s decision to accept or deny the
initiate a written authorization individual request to terminate a request.
permitting covered entities to release formerly agreed to restriction regarding 45 CFR 164.528: This provision
their protected health information to the use and disclosure of protected requires covered entities to permit an
entities of their choosing. The IHS–810 health information.
individual to request that the covered
will be used to document an 45 CFR 164.526: This provision
entity provide an accounting of
individual’s authorization to use or requires covered entities to permit an
individual to request that the covered disclosures of protected health
disclose their protected health
entity amend protected health information made by the covered entity.
information.
45 CFR 164.522: Section 164.522(a)(1) information. If the covered entity The form ‘‘IHS 913 Request for an
requires a covered entity to permit accepts the requested amendment, in Accounting of Disclosures’’ will be used
individuals to request that the covered whole or in part, the covered entity to document an individual’s request for
entity restrict the use and disclosure of must inform the individual that the an accounting of disclosures of their
their protected health information. The amendment is accepted and obtain the protected health information and the
covered entity may or may not agree to individual’s identification of and agency’s handling of the request.
the restriction. The form ‘‘IHS–912–1 agreement to have the covered entity Completed forms used in this
Request for Restriction(s)’’ will be used notify the relevant persons with which collection of information are filed in the
to document an individual’s request for the amendment needs to be shared. If medical record. Affected Public:
restriction of their protected health the covered entity denies the requested Individuals and households. Type of
information and whether IHS agreed or amendment, in whole or in part, the Respondents: Individuals. Burden
disagreed with the restriction. Section covered entity must provide the Hours: The table below provides the
164.522(a)(2)(1) permits a covered entity individual with a written denial. The estimated burden hours for this
to terminate its agreement to a form ‘‘IHS–911 Request for Correction/ information collection:

ESTIMATED ANNUAL BURDEN HOURS


Responses Burden per
No. of re- Total
45 CFR Section/IHS Form per respond- response*
spondents annual burden
ent (minutes)

164.508 IHS–810 ............................................................................................. 500,000 1 20 166,667


164.522(a)(1) IHS–912–1 ................................................................................ 15000 1 10 2,500
164.522(a)(2) IHS–912–2 ................................................................................ 5000 1 10 833
164.526 IHS–911 ............................................................................................. 7500 1 15 1,875
164.528 IHS–913 ............................................................................................. 15000 1 10 2,500

Total Annual Burden ................................................................................. 5 174,375


*For ease of understanding, burden hours are provided in actual minutes.

The total estimated burden for this technological collection techniques or Dated: October 28, 2002.
collection of information is 174,375 other forms of information technology. Charles W. Grim,
hours. Send Comments and Requests for Assistant Surgeon General, Interim Director.
There are no capital costs, operating Further Information: Send your written [FR Doc. 02–28056 Filed 11–4–02; 8:45 am]
costs and/or maintenance costs to
comments and requests for more BILLING CODE 4160–16–M
respondents.
Request for Comments: Your written information on the proposed collection
comments and/or suggestions are or requests to obtain a copy of the data
collection instrument(s) and DEPARTMENT OF THE INTERIOR
invited on one or more of the following
points: (a) Whether the information instructions to: Mr. Lance Hodahkwen,
Bureau of Land Management
collection activity is necessary to carry Sr., M.P.H., IHS Reports Clearance
out an agency function; (b) whether the Officer, 12300 Twinbrook Parkway, [WO–310–1310–PB–24–1A]
agency processes the information Suite 450, Rockville, MD 20852.1601,
call non-toll free (301) 443–5938, send OMB Approval Number 1004–0–162;
collected in a useful and timely fashion;
via facsimile to (301) 443-2316, or send Information Collection Submitted to
(c) the accuracy of public burden
your E-mail requests, comments, and the Office of Management and Budget
estimate (the estimated amount of time
Under the Paperwork Reduction Act
needed for individual respondents to return address to:
provide the requested information); (d) ihodahkw@hqe.ihs.gov. The Bureau of Land Management
whether the methodology and Comment Due Date: Your comments (BLM) has submitted a request to the
assumptions used to determine the regarding this information collection are Office of Management and Budget
estimate are logical; (e) ways to enhance best assured of having their full effect if (OMB) under the provisions of the
the quality, utility, and clarity of the received within 60-days of the date of Paperwork Reduction Act (44 U.S.C.
information being collected; and (f) 3501 et seq.) to extend a currently
this publication.
ways to minimize the public burden approved collection of information
through the use of automated, listed below. On May 14, 2002, the BLM
electronic, mechanical, or other published a notice in the Federal

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