Federal Register / Vol. 70, No. 230 / Thursday, December 1, 2005 / Notices 72123 

including economic and technical 

considerations and agency statutory 

missions. GSA shall identify and 

discuss all such factors including any 

essential considerations of national 

policy which is balanced by GSA in 

making its decision and state how those 

considerations entered into its decision. 

Supplemental Information: 

GSA invites interested individuals, 

organizations, and federal, state, and 

local agencies to participate in defining 

and identifying any significant impacts 

and issues to be studied in the EIS. The 

EIS will examine the short and longterm impacts on the natural and 

physical environment. The assessment 

will include but not be limited to 

impacts such as social environment, 

changes in land use, aesthetics, changes 

in adjacent park land, changes in traffic 

patterns and access to the ‘‘D’’ street 

intersection, economic impacts, and 

consideration of City planning and 

zoning requirements. The EIS will 

examine measures to mitigate 

significant adverse impacts resulting 

from the proposed action. Concurrent 

with NEPA implementation, GSA will 

also implement its consultation 

responsibilities under Section 106 of the 

National Historic Preservation Act to 

identify potential impacts to existing 

historic or cultural resources. GSA will 

consult with Native American tribes 

through-out the NEPA process. 

The EIS will consider a no-action 

alternative and action alternatives. The 

no-action alternative would continue 

the occupancy in the existing Peace 

Arch Port of Entry facility in Blaine. The 

action alternatives will consist of three 

different configurations for construction 

of a new port of Entry facility. 

Dated: 11/18/2005. 

William L. DuBray, 

Executive Director, Region 10. 

[FR Doc. 05–23522 Filed 11–30–05; 8:45 am] 

BILLING CODE 6820–EP–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0335] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Device 

Recall Authority 

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. 

DATES: Fax written comments on the 

collection of information by January 3, 

2006. 

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. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Medical Device Recall Authority—21 

CFR Part 810 (OMB Control Number 

0910–0432)—Extension 

This collection implements medical 

device recall authority provisions under 

section 518(e) of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

360h) and part 810 (21 CFR part 810). 

Section 518(e) of the act gives FDA the 

authority to issue an order requiring the 

appropriate person, including 

manufacturers, importers, distributors, 

and retailers of a device, to immediately 

cease distribution of such device, to 

immediately notify health professionals 

and device-user facilities of the order, 

and to instruct such professionals and 

facilities to cease use of such device, if 

FDA finds that there is reasonable 

probability that the device intended for 

human use would cause serious adverse 

health consequences or death. 

Section 518(e) of the act sets out a 

three-step procedure for issuance of a 

mandatory device recall order. First, if 

there is a reasonable probability that a 

device intended for human use would 

cause serious, adverse health 

consequences or death, FDA may issue 

a cease distribution and notification 

order requiring the appropriate person 

to immediately do the following: (1) 

Cease distribution of the device, (2) 

notify health professionals and device 

user facilities of the order, and (3) 

instruct those professionals and 

facilities to cease use of the device. 

Second, FDA will provide the person 

named in the cease distribution and 

notification order with the opportunity 

for an informal hearing on whether the 

order should be modified, vacated, or 

amended to require a mandatory recall 

of the device. Third, after providing the 

opportunity for an informal hearing, 

FDA may issue a mandatory recall order 

if the agency determines that such an 

order is necessary. 

The information collected under the 

recall authority will be used by FDA to 

ensure that all devices entering the 

market are safe and effective, to 

accurately and immediately detect 

serious problems with medical devices, 

and to remove dangerous and defective 

devices from the market. 

The respondents to this proposed 

collection of information are 

manufacturers, importers, distributors, 

and retailers of medical devices. 

In the Federal Register of September 

2, 2005 (70 FR 52397), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. No comments were received 

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 

810.10(d) 2 1 2 8 16 

810.11(a) 1 1 1 8 8 

810.12(a) through (b) 1 1 1 8 8 

72124 Federal Register / Vol. 70, No. 230 / Thursday, December 1, 2005 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

21 CFR Section No. of Respondents Annual Frequency per 

Response 

Total Annual Responses Hours per Response Total Hours 

810.14 2 1 2 16 32 

810.15(a) through (d) 2 1 2 16 32 

810.15(e) 10 1 10 1 10 

810.16 2 12 24 40 960 

810.17 2 1 2 8 16 

Total 1,082 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The following burden estimates are 

based on FDA’s experience with 

voluntary recalls under 21 CFR part 7. 

FDA expects no more than two 

mandatory recalls per year, as most 

recalls are done voluntarily. 

Section 810.10(d)—FDA estimates 

that it will take approximately 8 hours 

for the person named in a cease 

distribution and notification order to 

gather and submit the information 

required by this section. 

The total estimated annual burden is 

16 hours. 

Section 810.11(a)—Based on 

experience in similar situations, FDA 

expects that there will be only one 

request for a regulatory hearing per year 

and that it will take approximately 8 

hours to prepare this request. 

Section 810.12(a) and (b)—Based on 

experience in similar situations, FDA 

expects that there will be only one 

written request for a review of a cease 

distribution and notification order per 

year and that it will take approximately 

8 hours to prepare this request. 

Section 810.14—Based upon its 

experience with voluntary recalls, FDA 

estimates that it will take approximately 

16 hours to develop a strategy for 

complying with the order. 

Section 810.15(a) through (d)—Based 

upon its experience with voluntary 

recalls, FDA estimates that it will take 

approximately 16 hours to notify each 

health professional, user facility, or 

individual of the order. 

Section 810.15(e)—Based upon its 

experience with voluntary recalls, FDA 

estimates that there will be 

approximately five consignees per recall 

(10 per year) who will be required to 

notify their consignees of the order. 

FDA estimates that it will take them 

about 1 hour to do so. 

Section 810.16—FDA estimates that it 

would take no more than 40 hours to 

assemble and prepare a written status 

report required by a recall. The status 

reports are prepared by manufacturers 

six to twelve times each year. Therefore, 

each manufacturer would spend no 

more than 480 hours each year 

preparing status reports. If there were 

two FDA invoked recalls each year, the 

total burden hours estimated would be 

960 hours each year. 

Section 810.17—Based on experience 

with similar procedures, FDA estimates 

that it would take 8 hours to draft a 

written request for termination of a 

cease distribution and notification or 

mandatory recall order. 

Dated: November 23, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–23519 Filed 11–30–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005D–0438] 

Draft Guidance for Industry on Safety, 

Efficacy, and Pharmacokinetic Studies 

to Support Marketing of Immune 

Globulin Intravenous (Human) as 

Replacement Therapy for Primary 

Humoral Immunodeficiency; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft document entitled 

‘‘Guidance for Industry: Safety, Efficacy, 

and Pharmacokinetic Studies to Support 

Marketing of Immune Globulin 

Intravenous (Human) as Replacement 

Therapy for Primary Humoral 

Immunodeficiency,’’ dated November 

2005. The draft guidance document 

provides recommendations for testing 

the safety, efficacy, and 

pharmacokinetics of immune globulin 

intravenous (human) (IGIV) products as 

replacement therapy in primary 

humoral immunodeficiency. The draft 

guidance document is intended to assist 

sponsors with the design of clinical 

trials to assess IGIV as replacement 

therapy in primary humoral 

immunodeficiency. 

DATES: Submit written or electronic 

comments on the draft guidance by 

March 1, 2006, to ensure their adequate 

consideration in the preparation of the 

final guidance. General comments on 

agency guidance documents are 

welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448. 

Send one self-addressed adhesive label 

to assist the office in processing your 

requests. The draft guidance may also be 

obtained by mail by calling the Center 

for Biologics Evaluation and Research at 

1–800–835–4709 or 301–827–1800. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

Submit written comments on the draft 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

FOR FURTHER INFORMATION CONTACT: 

Paula S. McKeever, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft document entitled ‘‘Guidance for