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49654 Federal Register / Vol. 70, No.

163 / Wednesday, August 24, 2005 / Notices

announcements on the HHS/CDC Web ADDRESSES: The Office of Management reason(s) for the removal or correction,
site, Internet address: http:// and Budget (OMB) is still experiencing risk evaluation, quantity produced, (Click on ‘‘Funding’’ then significant delays in the regular mail, distribution information, firm’s recall
‘‘Grants and Cooperative Agreements’’), including first class and express mail, strategy, a copy of any recall
and on the Web site of the HHS Office and messenger deliveries are not being communication(s), and a contact
of Global Health Affairs, Internet accepted. To ensure that comments on official; notifying direct accounts of the
address: the information collection are received, recall, providing guidance regarding
Dated: August 17, 2005. OMB recommends that written further distribution, giving instructions
William P. Nichols,
comments be faxed to the Office of as to what to do with the product,
Information and Regulatory Affairs, providing recipients with a ready means
Director, Procurement and Grants Office,
Centers for Disease Control and Prevention,
OMB, Attn: Fumie Yokota, Desk Officer of reporting to the recalling firm;
U.S. Department of Health and Human for FDA, FAX: 202–395–6974. submitting periodic status reports so
Services. FOR FURTHER INFORMATION CONTACT: that FDA may assess the progress of the
[FR Doc. 05–16838 Filed 8–23–05; 8:45 am] Karen Nelson, Office of Management recall. Status report information may be
BILLING CODE 4163–18–P Programs (HFA–250), Food and Drug determined by, among other things
Administration, 5600 Fishers Lane, evaluation return reply cards,
Rockville, MD 20857, 301–827–1482. effectiveness checks and product
DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: In returns; and providing the opportunity
HUMAN SERVICES compliance with 44 U.S.C. 3507, FDA for a firm to request in writing that FDA
has submitted the following proposed terminate the recall.
Food and Drug Administration collection of information to OMB for A search of the FDA database was
review and clearance. performed to determine the number of
[Docket No. 2004N–0442]
recalls that took place during fiscal year
Food and Drug Administration Recall 2003. The resulting number of recalls
Agency Information Collection Regulations (Guidelines)—(OMB
Activities; Submission for Office of from this database search (2,375) is used
Control Number 0910–0249)—Extension in estimating the current annual
Management and Budget Review;
Comment Request; Food and Drug Section 701 of the Federal Food, Drug, reporting burden for this report. FDA
Administration Recall Regulations and Cosmetic Act (21 U.S.C. 371) and estimates the total annual industry
(Guidelines) part 7 (21 CFR part 7), subpart C sets burden to collect and provide the above
forth the recall regulations (guidelines) information to 201,875 burden hours.
AGENCY: Food and Drug Administration, and provides guidance to manufacturers The following is a summary of the
HHS. on recall responsibilities. The estimated annual burden hours for
ACTION: Notice. guidelines apply to all FDA-regulated recalling firms (manufacturers,
products (i.e., food, including animal processors, and distributors) to comply
SUMMARY: The Food and Drug feed; drugs, including animal drugs; with the voluntary reporting
Administration (FDA) is announcing medical devices, including in vitro requirements of FDA’s recall
that a proposed collection of diagnostic products; cosmetics; and regulations.
information has been submitted to the biological products intended for human Recognizing that there may be a vast
Office of Management and Budget use). These responsibilities include difference in the information collection
(OMB) for review and clearance under development of a recall strategy that and reporting time involved in different
the Paperwork Reduction Act of 1995. requires time by the firm to determine recalls of FDA’s regulated products,
DATES: Fax written comments on the the actions or procedures required to FDA estimates on average the burden of
collection of information by September manage the recall; providing FDA with collection for recall information to be as
23, 2005. complete details of the recall including follows:


Annual Frequency per Total Annual Re- Hours per Re-
21 CFR Section No. of Respondents Total Hours
Response sponses sponse

Recall Strategy 2,375 1 2,375 15 35,625

Firm Initiated Recall & Pub-
lic Warnings Recall Com-
munications 2,375 1 2,375 20 47,500
Recall Status Reports &
Followup 2,375 4 9,500 10 95,000
Termination of a Recall 2,375 1 2,375 10 23,750
Total 201,875
1There are no capital costs or operating and maintenance costs associated with this collection of information.

The annual reporting burdens are information, the agency estimates it will devices, and biologicals to immediately
explained as follows: receive 2,375 responses annually. notify the appropriate FDA district
office of such actions. The firm is to
Recall Strategy Firm Initiated Recall and Recall
provide complete details of the recall
Requests firms to develop a recall reason, risk, evaluation, quantity
strategy including provision for public Requests firms that voluntarily produced, distribution information,
warnings and effectiveness checks. remove or correct foods and drugs firm’s recall strategy, and a contact
Under this portion of the collection of (human or animal), cosmetics, medical official as well as requires firms to

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Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 49655

notify their direct accounts of the recall comments on the collection of with the Secretary of Health and Human
and to provide recipients with a ready information to the Division of Dockets Services, on or before December 31 of
means of reporting to the recalling firm. Management (HFA–305), Food and Drug each year, his or her name, place of
Under these portions of the collection of Administration, 5630 Fishers Lane, rm. business, and all such establishments
information, the agency estimates it will 1061, Rockville, MD 20852. All submit, among other information, a
receive 2,375 responses annually for comments should be identified with the listing of all drug or device products
each. docket number found in brackets in the manufactured, prepared, propagated,
heading of this document. compounded, or processed by him or
Recall Status Reports her for commercial distribution. In part
Requests that recalling firms provide Jonna Capezzuto, Office of Management 607 (21 CFR part 607), FDA has issued
periodic status reports so FDA can Programs (HFA–250), Food and Drug regulations implementing these
ascertain the progress of the recall. This Administration, 5600 Fishers Lane, requirements for manufacturers of
collection of information will generate Rockville, MD 20857, 301–827–4659. human blood and blood products.
approximately 9,500 responses Section 607.20(a) requires certain
SUPPLEMENTARY INFORMATION: Under the establishments that engage in the
PRA (44 U.S.C. 3501–3520), Federal manufacture of blood products to
In the Federal Register of October 12,
agencies must obtain approval from the register and to submit a list of blood
2004 (69 FR 60630), FDA published a
Office of Management and Budget products in commercial distribution.
60-day notice requesting public
(OMB) for each collection of Section 607.21 requires the
comment on the information collection
information they conduct or sponsor. establishments entering into the
provisions. No comments were received.
‘‘Collection of information’’ is defined manufacturing of blood products to
Dated: August 17, 2005. in 44 U.S.C. 3502(3) and 5 CFR register within 5 days after beginning
Jeffrey Shuren, 1320.3(c) and includes agency requests such operation and to submit a blood
Assistant Commissioner for Policy. or requirements that members of the product listing at that time. In addition,
[FR Doc. 05–16846 Filed 8–23–05; 8:45 am] public submit reports, keep records, or establishments are required to register
BILLING CODE 4160–01–S provide information to a third party. annually between November 15 and
Section 3506(c)(2)(A) of the PRA (44 December 31 and update their blood
U.S.C. 3506(c)(2)(A)) requires Federal product listing every June and
DEPARTMENT OF HEALTH AND agencies to provide a 60-day notice in December of each year. Section 607.22
HUMAN SERVICES the Federal Register concerning each requires the use of Form FDA 2830,
proposed collection of information, Blood Establishment Registration and
Food and Drug Administration including each proposed extension of an Product Listing, for initial registration,
[Docket No. 2005N–0327] existing collection of information, for annual registration, and for blood
before submitting the collection to OMB product listing. Section 607.25 indicates
Agency Information Collection for approval. To comply with this the information required for
Activities; Proposed Collection; requirement, FDA is publishing notice establishment registration and blood
Comment Request; Blood of the proposed collection of product listing. Section 607.26 requires
Establishment Registration and information set forth in this document. certain changes to be submitted as
Product Listing, Form FDA 2830 With respect to the following amendments to the establishment
collection of information, FDA invites registration within 5 days of such
AGENCY: Food and Drug Administration, comments on these topics: (1) Whether changes. Section 607.30 requires
HHS. the proposed collection of information establishments to update their blood
ACTION: Notice. is necessary for the proper performance product listing information every June
of FDA’s functions, including whether and December, or at the discretion of the
SUMMARY: The Food and Drug
the information will have practical registrant at the time the change occurs.
Administration (FDA) is announcing an
utility; (2) the accuracy of FDA’s Section 607.31 requires that additional
opportunity for public comment on the
estimate of the burden of the proposed blood product listing information be
proposed collection of certain
collection of information, including the provided upon FDA request. Section
information by the agency. Under the
validity of the methodology and 607.40 requires foreign blood product
Paperwork Reduction Act of 1995 (the
assumptions used; (3) ways to enhance establishments to register and submit
PRA), Federal agencies are required to
the quality, utility, and clarity of the the blood product listing information,
publish notice in the Federal Register
information to be collected; and (4) the name and address of the
concerning each proposed collection of
ways to minimize the burden of the establishment, and the name of the
information, including each proposed
collection of information on individual responsible for submitting
extension of an existing collection of
respondents, including through the use blood product listing information as
information, and to allow 60 days for
of automated collection techniques, well as the name, address, and phone
public comment in response to the
when appropriate, and other forms of number of its U.S. agent.
notice. This notice solicits comments on Among other uses, this information
information technology.
the information collection requirements assists FDA in its inspections of
relating to the blood establishment Blood Establishment Registration and
facilities, and its collection is essential
registration and product listing Product Listing, Form FDA 2830—21
to the overall regulatory scheme
requirements and Form FDA 2830. CFR Part 607 (OMB Control Number
designed to ensure the safety of the
DATES: Submit written or electronic 0910–0052)—Extension
Nation’s blood supply. Form FDA 2830
comments on the collection of Under section 510 of the Federal is used to collect this information.
information by October 24, 2005. Food, Drug, and Cosmetic Act (21 U.S.C. Respondents to this collection of
ADDRESSES: Submit electronic 360), any person owning or operating an information are human blood and
comments on the collection of establishment that manufactures, plasma donor centers, blood banks,
information to prepares, propagates, compounds, or certain transfusion services, other blood
dockets/ecomments. Submit written processes a drug or device must register product manufacturers, and

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