Vous êtes sur la page 1sur 2

Federal Register / Vol. 71, No.

209 / Monday, October 30, 2006 / Notices 63327

Dated: October 23, 2006. obtained by mail by calling CBER at 1– on how to report the manufacturing
Jeffrey Shuren, 800–835–4709 or 301–827–1800. See change to FDA under 21 CFR 601.12.
Assistant Commissioner for Policy. the SUPPLEMENTARY INFORMATION section In the Federal Register of May 12,
[FR Doc. E6–18067 Filed 10–27–06; 8:45 am] for electronic access to the guidance 2004 (69 FR 26399), FDA announced the
BILLING CODE 4160–01–S
document. availability of the draft guidance
Submit written comments on the entitled ‘‘Guidance for Industry:
guidance to the Division of Dockets Acceptable Full-Length Donor History
DEPARTMENT OF HEALTH AND Management (HFA–305), Food and Drug Questionnaire and Accompanying
HUMAN SERVICES Administration, 5630 Fishers Lane, rm. Materials for Use in Screening Human
1061, Rockville, MD 20852. Submit Donors of Blood and Blood
Food and Drug Administration electronic comments to http:// Components’’ dated April 2004. This
www.fda.gov/dockets/ecomments. draft guidance contained the full-length
[Docket No. 2004D–0198]
FOR FURTHER INFORMATION CONTACT: donor history questionnaire and
Guidance for Industry on Brenda R. Friend, Center for Biologics accompanying materials (Version No. 1,
Implementation of Acceptable Full- Evaluation and Research (HFM–17), dated April 2004) (v.DHQ–1). FDA
Length Donor History Questionnaire Food and Drug Administration, 1401 received several comments on the draft
and Accompanying Materials for Use Rockville Pike, suite 200N, Rockville, guidance and those comments were
in Screening Donors of Blood and MD 20852–1448, 301–827–6210. considered as the guidance was
Blood Components; Availability finalized. A summary of changes to the
SUPPLEMENTARY INFORMATION:
guidance includes the following: (1)
AGENCY: Food and Drug Administration, I. Background Added a statement to direct inquiries
HHS. regarding the v.DHQ–1.1 or other AABB
FDA is announcing the availability of
ACTION: Notice. DHQ documents to the task force; (2)
a document entitled ‘‘Guidance for
clarified how to implement acceptable
SUMMARY: The Food and Drug
Industry: Implementation of Acceptable
DHQ documents, including v.DHQ–1.1,
Administration (FDA) is announcing the Full-Length Donor History
and the self-administration of these
availability of a document entitled Questionnaire and Accompanying
documents; and (3) added a separate
‘‘Guidance for Industry: Implementation Materials for Use in Screening Donors of
Web site link to access all DHQ
of Acceptable Full-Length Donor Blood and Blood Components,’’ dated
documents that FDA has recognized as
History Questionnaire and October 2006. The guidance document
acceptable. In addition, FDA received
Accompanying Materials for Use in provides blood establishments that
many comments on the v.DHQ–1, and
Screening Donors of Blood and Blood collect blood and blood components
forwarded these comments to the task
Components,’’ dated October 2006. The intended for transfusion or for further
force. In response, the task force
guidance document provides blood manufacture with advice on reporting to
submitted updated DHQ documents
establishments that collect blood and FDA a manufacturing change consisting
(v.DHQ–1.1), for FDA’s review. The
blood components intended for of the implementation of DHQ
guidance announced in this notice
transfusion or for further manufacture documents. Acceptable DHQ documents
finalizes the draft guidance dated April
with advice on reporting to FDA a (DHQ documents that provide licensed
2004, and refers to the v.DHQ–1.1.
manufacturing change consisting of the and unlicensed manufacturers with one The guidance is being issued
implementation of a standardized full- means of complying with the FDA consistent with FDA’s good guidance
length donor history questionnaire and requirements for collecting donor practices regulation (21 CFR 10.115).
accompanying materials (DHQ history information) will provide The guidance represents FDA’s current
documents). The guidance document manufacturers with a specific process thinking on this topic. It does not create
addresses which DHQ documents are for administering questions to donors of or confer any rights for or on any person
acceptable, and establishes the process blood and blood components to and does not operate to bind FDA or the
for FDA to recognize other DHQ determine their eligibility to donate. public. An alternative approach may be
documents in the future. The guidance The guidance document advises used if such approach satisfies the
announced in this notice finalizes the licensed manufacturers who choose to requirements of the applicable statutes
draft guidance entitled ‘‘Guidance for implement acceptable DHQ documents and regulations.
Industry: Acceptable Full-Length Donor on how to report the manufacturing
change to FDA, and recognizes the II. Paperwork Reduction Act of 1995
History Questionnaire and
Accompanying Materials for Use in Donor History Questionnaire Version This guidance refers to previously
Screening Human Donors of Blood and No. 1.1 dated June 2005 (v.DHQ–1.1), approved collections of information
Blood Components’’ dated April 2004. prepared by the AABB (formerly known found in FDA regulations. These
as the American Association of Blood collections of information are subject to
DATES: Submit written or electronic
Banks) Donor History Task Force, as review by the Office of Management and
comments on agency guidances at any acceptable DHQ documents.
time. Budget (OMB) under the Paperwork
In the future, FDA may recognize Reduction Act of 1995 (44 U.S.C. 3501–
ADDRESSES: Submit written requests for other DHQ documents as acceptable, 3520). The collections of information in
single copies of the guidance to the and intends to make all of the 21 CFR 606.160 have been approved
Office of Communication, Training, and acceptable DHQ documents available on under OMB control numbers 0910–
Manufacturers Assistance (HFM–40), FDA’s Web site. FDA believes that 0116; those in 21 CFR 601.12 have been
Center for Biologics Evaluation and acceptable DHQ documents will assist approved under 0910–0338.
Research (CBER), Food and Drug manufacturers in complying with the
sroberts on PROD1PC70 with NOTICES

Administration, 1401 Rockville Pike, regulations under 21 CFR 640.3 and III. Comments
suite 200N, Rockville, MD 20852–1448. 640.63. The guidance also advises Interested persons may, at any time,
Send one self-addressed adhesive label licensed manufacturers of blood and submit to the Division of Dockets
to assist the office in processing your blood components who choose to Management (see ADDRESSES) written or
requests. The guidance may also be implement acceptable DHQ documents electronic comments regarding the

VerDate Aug<31>2005 02:16 Oct 28, 2006 Jkt 211001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\30OCN1.SGM 30OCN1
63328 Federal Register / Vol. 71, No. 209 / Monday, October 30, 2006 / Notices

guidance. Submit a single copy of office in processing your requests. or confer any rights for or on any person
electronic comments or two paper Submit written comments on the draft and will not operate to bind FDA or the
copies of any mailed comments, except guidance document to the Division of public. An alternative approach may be
that individuals may submit one paper Dockets Management (HFA–305), Food used if such approach satisfies the
copy. Comments are to be identified and Drug Administration, 5630 Fishers requirements of the applicable statutes
with the docket number found in the Lane, rm. 1061, Rockville, MD 20852. and regulations.
brackets in the heading of this Submit electronic comments to http:///
document. A copy of the guidance and www.fda.gov/dockets/ecomments. See III. Paperwork Reduction Act of 1995
received comments are available for the SUPPLEMENTARY INFORMATION section
This draft guidance refers to
public examination in the Division of for electronic access to the draft
previously approved collections of
Dockets Management between 9 a.m. guidance document.
and 4 p.m., Monday through Friday. information found in FDA regulations.
FOR FURTHER INFORMATION CONTACT:
These collections of information are
IV. Electronic Access Dragan Momcilovic, Center for
subject to review by the Office of
Veterinary Medicine (HFV–220), Food
Persons with access to the Internet Management and Budget (OMB) under
and Drug Administration, 7519 Standish
may obtain the guidance at either http:// the Paperwork Reduction Act of 1995
Pl., Rockville, MD 20855, 240–453–
www.fda.gov/cber/guidelines.htm or 6856, e-mail: DMomcilo@cvm.fda.gov. (44 U.S.C. 3501–3520). The collections
http://www.fda.gov/ohrms/dockets/ of information in 21 CFR 514.1(b)(3)
SUPPLEMENTARY INFORMATION:
default.htm. have been approved under OMB control
Dated: October 20, 2006. I. Background number 0910–0032.
Jeffrey Shuren, FDA is announcing the availability of IV. Comments
Assistant Commissioner for Policy. a draft guidance for industry entitled
[FR Doc. E6–18068 Filed 10–27–06; 8:45 am] ‘‘Draft Guidance for Industry: Blue Bird This draft guidance document is being
BILLING CODE 4160–01–S Medicated Feed Labels.’’ This draft distributed for comment purposes only
guidance is intended to provide NADA and is not intended for implementation
sponsors with CVM’s current thinking at this time. Interested persons may
DEPARTMENT OF HEALTH AND on what constitutes recommended submit to the Division of Dockets
HUMAN SERVICES content and format of representative Management (see ADDRESSES) written or
labels for new animal drugs intended for electronic comments regarding this
Food and Drug Administration use in the manufacture of medicated document. Submit a single copy of
[Docket No. 2006D–0413] feeds. An NADA for a Type A electronic comments or two paper
medicated article is required to include, copies of any mailed comments, except
Draft Guidance for Industry; Blue Bird among other things, representative that individuals may submit one paper
Medicated Feed Labels; Availability labeling proposed to be used for Type B copy. Comments are to be identified
and Type C medicated feeds containing with the docket number found in
AGENCY: Food and Drug Administration, the new animal drug (21 CFR
HHS. brackets in the heading of this
514.1(b)(3)(v)(b)). A Type A medicated
ACTION: Notice. document. A copy of the draft guidance
article is defined in § 558.3(b)(2) (21
and received comments may be seen in
CFR 558.3(b)(2)) as ‘‘intended solely for
SUMMARY: The Food and Drug the Division of Dockets Management
use in the manufacture of another Type
Administration (FDA) is announcing the A medicated article or a Type B or Type between 9 a.m. and 4 p.m., Monday
availability of a draft guidance for C medicated feed.’’ Type B medicated through Friday.
industry (#181) entitled ‘‘Draft Guidance feed is defined in § 558.3(b)(3) as
for Industry: Blue Bird Medicated Feed V. Electronic Access
‘‘intended solely for the manufacture of
Labels.’’ This draft guidance is intended other medicated feeds (Type B or Type Electronic comments may be
to provide new animal drug application C).’’ Type C medicated feed is defined submitted on the Internet at http://
(NADA) sponsors with the Center for in § 558.3(b)(4) as ‘‘intended as the www.fda.gov/dockets/ecomments. Once
Veterinary Medicine’s (CVM’s) current complete feed for the animal or may be on the Internet site, select Docket No.
thinking on what constitutes fed ‘‘top dressed’’ (added on top of 2006D–0413, ‘‘Draft Guidance for
recommended content and format of usual ration) on or offered ‘‘free-choice’’
representative labels for new animal Industry: Blue Bird Medicated Feed
(e.g., supplement) in conjunction with Labels’’ and follow the directions.
drugs intended for use in the other animal feed.’’
manufacture of medicated feeds. Copies of this draft guidance may be
This draft guidance provides obtained on the Internet from the CVM
DATES: Submit written or electronic recommendations on the content and
comments on the draft guidance by home page at http://www.fda.gov/cvm.
format of the representative labeling for
January 16, 2007, to ensure their Type B and Type C medicated feeds Dated: October 23, 2006.
adequate consideration in preparation of only. This representative labeling is also Jeffrey Shuren,
the final document. General comments known as ‘‘Blue Bird’’ labeling. This Assistant Commissioner for Policy.
on agency guidance documents are draft guidance does not address the [FR Doc. E6–18148 Filed 10–27–06; 8:45 am]
welcome at any time. labeling of Type A medicated articles. BILLING CODE 4160–01–S
ADDRESSES: Submit written requests for
single copies of the draft guidance II. Significance of Guidance
document to the Communications Staff This level 1 draft guidance is being
sroberts on PROD1PC70 with NOTICES

(HFV–12), Center for Veterinary issued consistent with FDA’s good


Medicine, Food and Drug guidance practices regulation (21 CFR
Administration, 7519 Standish Pl., 10.115). The draft guidance, when
Rockville, MD 20855. Send one self- finalized, will represent FDA’s current
addressed adhesive label to assist that thinking on this topic. It does not create

VerDate Aug<31>2005 02:16 Oct 28, 2006 Jkt 211001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\30OCN1.SGM 30OCN1