Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Notices 51041 

SUPPLEMENTARY INFORMATION: The 

public workshop helps fulfill the 

Department of Health and Human 

Services’ and FDA’s important mission 

to protect the public health. The 

workshop will provide those engaged in 

FDA-regulated (human) clinical trials 

with information on a number of topics 

concerning FDA requirements related to 

informed consent, clinical investigation 

requirements, IRB inspections, 

electronic record requirements, and 

investigator initiated research. Topics 

for discussion include the following: (1) 

What FDA Expects in a Pharmaceutical 

Clinical Trial; (2) Adverse Event 

Reporting—Science, Regulation, Error, 

and Safety; (3) Part 11 Compliance— 

Electronic Signatures; (4) Informed 

Consent Regulations; (5) IRB 

Regulations and FDA Inspections; (6) 

Keeping Informed and Working 

Together; (7) FDA Conduct of Clinical 

Investigator Inspections; (8) Meetings 

With FDA: Why, When, and How; (9) 

Investigator Initiated Research; (10) 

Medical Device Aspects of Clinical 

Research; (11) Working With FDA’s 

Center for Biologics Evaluation and 

Research; (12) The Inspection is Over— 

What Happens Next? Possible FDA 

Compliance Actions; (13) Ethical Issues 

in Subject Enrollment; (14) Medical 

Device Aspects of Clinical Research); 

(15) Are We There Yet? An Overview of 

the FDA GCP Program. 

FDA has made education of the drug 

and device manufacturing community a 

high priority to help ensure the quality 

of FDA-regulated drugs and devices. 

The public workshop helps to achieve 

objectives set forth in section 406 of the 

FDA Modernization Act of 1997 (21 

U.S.C. 393) which includes working 

closely with stakeholders and 

maximizing the availability and clarity 

of information to stakeholders and the 

public. The public workshop also is 

consistent with the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (Pub. L. 104–121) as outreach 

activities by Government Agencies to 

small businesses. 

Dated: August 10, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–20858 Filed 8–16–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Hemoglobin Standards and 

Maintaining Adequate Iron Stores in 

Blood Donors; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) is announcing a public workshop 

entitled: ‘‘Hemoglobin Standards and 

Maintaining Adequate Iron Stores in 

Blood Donors.’’ The purpose of this 

public workshop is to discuss blood 

donor hemoglobin and hematocrit 

qualification standards in the United 

States, its impact on donor safety and 

blood availability, and potential 

measures to maintain adequate iron 

stores in blood donors. The public 

workshop has been planned in 

partnership with the Department of 

Health and Human Services (HHS) 

Office of the Assistant Secretary for 

Health, the National Heart, Lung and 

Blood Institute, America’s Blood 

Centers, AABB, and the Plasma Protein 

Therapeutics Association. This public 

workshop will include presentations 

and panel discussions by experts 

knowledgeable in the field from 

academic institutions, government 

agencies, and industry. 

Dates and Times: The public 

workshop will be held on November 8, 

2011, from 8 a.m. to 5:30 p.m. and 

November 9, 2011, from 8 a.m. to 3 p.m. 

Location: The public workshop will 

be held at the Natcher Conference 

Center, Main Auditorium, Building 45, 

National Institutes of Health, 45 Center 

Dr., Bethesda, MD 20892. 

Contact Person: Rhonda Dawson, 

Center for Biologics Evaluation and 

Research (HFM–302), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448, 

301–827–6129, FAX: 301–827–2843, 

e-mail: rhonda.dawson@fda.hhs.gov. 

Registration: Mail, fax, or email your 

registration information (including 

name, title, firm name, address, 

telephone and fax numbers) to Rhonda 

Dawson (see Contact Person) by October 

14, 2011. There is no registration fee for 

the public workshop. Early registration 

is recommended because seating is 

limited. Registration on the day of the 

public workshop will be provided on a 

space available basis beginning at 

7:30 a.m. 

If you need special accommodations 

due to a disability, please contact 

Rhonda Dawson (see Contact Person) at 

least 7 days in advance. 

SUPPLEMENTARY INFORMATION: 

Under FDA’s current regulations, 

allogeneic blood donors must have a 

hemoglobin level of no less than 12.5 

grams of hemoglobin per 100 milliliters 

of blood or a hematocrit value of 38 

percent prior to donation (21 CFR 

640.3(b)(3) and 640.63(c)(3)). 

Hemoglobin and hematocrit 

measurements are typically obtained 

from a small sample of blood drawn 

from a finger or vein. New technologies 

that potentially allow for less invasive, 

faster, and more convenient methods of 

measuring blood donor hemoglobin and 

hematocrit levels are being studied. A 

low donor hemoglobin and hematocrit 

level is the most common reason that 

prospective blood donors, particularly 

women, are deferred. 

Allogeneic donors of a unit of red 

blood cells generally may not donate 

more than once in an 8 week period to 

ensure recovery of their red blood cells 

and iron stores (21 CFR 640.3). 

Nonetheless, some donors, especially 

repeat and premenopausal female 

donors, can develop iron deficiency, 

with or without anemia, from blood 

donation. Improved understanding of 

iron loss in blood donors may help 

reduce donor deferrals due to low 

hemoglobin and hematocrit levels and 

reduce iron deficiency that can result 

from blood donation. Different strategies 

to minimize iron deficiency in blood 

donors (e.g., testing for iron stores, 

adjusting the donation interval, or 

providing iron replacement) have been 

explored in the past. Changes in 

qualifying hemoglobin levels have been 

discussed in various forums for both 

men and women to bring these levels 

into closer concordance with population 

norms. However, the potential risks and 

benefits of these strategies require 

further discussion. 

This public workshop will serve as a 

forum for discussion of hemoglobin and 

hematocrit donation standards, current 

methods for hemoglobin measurement, 

iron loss and iron measurement 

methods in blood donors, and strategies 

to maintain adequate donor iron stores. 

The first day of the public workshop 

will include presentations and panel 

discussions on the following topics: (1) 

Hemoglobin standards for blood donors 

in the United States; (2) studies of 

hemoglobin distribution and deferral 

patterns in blood donors; and (3) 

measurement of hemoglobin and 

hematocrit and iron levels in blood 

donors. The second day of the public 

workshop will include a discussion of 

the following topics: (1) Iron 


Emcdonald on DSK2BSOYB1PROD with NOTICES
51042 Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Notices 

metabolism, iron stores and iron 

deficiency in blood donors; and (2) 

potential methods to maintain adequate 

iron stores in blood donors, including 

adjustment of the interdonation interval, 

iron measurement and iron 

replacement. 

Transcripts: Please be advised that as 

soon as possible after a transcript of the 

public workshop is available, it will be 

accessible on the Internet at: http://

www.fda.gov/BiologicsBloodVaccines/

NewsEvents/WorkshopsMeetings

Conferences/TranscriptsMinutes/

default.htm. Transcripts of the public 

workshop may also be requested in 

writing from the Division of Freedom of 

Information (ELEM–1029), Food and 

Drug Administration, 12420 Parklawn 

Dr., Element Bldg., Rockville, MD 

20857. 

Dated: August 10, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–20861 Filed 8–16–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. chapter 35). To request a copy of 

the clearance requests submitted to 

OMB for review, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Office on (301) 443– 

1129. 

The following request has been 

submitted to the Office of Management 

and Budget for review under the 

Paperwork Reduction Act of 1995: 

Proposed Project: Health Education 

Assistance Loan (HEAL) Program: 

Lender’s Application for Insurance 

Claim Form and Request for Collection 

Assistance Form (OMB No. 0915– 

0036)—Extension 

The clearance request is for an 

extension of two forms that are 

currently approved by OMB. HEAL 

lenders use the Lenders Application for 

Insurance Claim to request payment 

from the Federal Government for 

federally insured loans lost due to 

borrowers’ death, disability, bankruptcy, 

or default. The Request for Collection 

Assistance form is used by HEAL 

lenders to request federal assistance 

with the collection of delinquent 

payments from HEAL borrowers. The 

annual estimate of burden is as follows: 

Form Number of 

respondents 

Responses per 

respondent Total responses Hours per response 

Total burden 

hours 

Lender’s Application for Insurance Claim 

Form 510 ...................................................... 13 28 364 0.50 182 

Request for Collection Assistance Form 513 .. 13 445 5,785 0.17 983 

Total Burden ............................................. 26 ............................ ............................ ............................ 1,165 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent within 30 days of this notice to 

the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov 

or by fax to 202–395–6974. Please direct 

all correspondence to the ‘‘attention of 

the desk officer for HRSA.’’ 

Dated: August 11, 2011. 

Reva Harris, 

Acting Director, Division of Policy and 

Information Coordination. 

[FR Doc. 2011–20999 Filed 8–16–11; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; National Institutes of Health 

Construction Grants 

SUMMARY: In compliance with the 

requirement of section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for public comment on proposed data 

collection projects, the National 

Institutes of Health (NIH) will publish 

periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection: Title: National 

Institutes of Health Construction Grants 

42 CFR Part 52b (Final Rule). Type of 

Information Collection Request: 

Extension of OMB Control No. 0925– 

0424, expiration date 10/31/2011. Need 

and Use of the Information Collection: 

This request is for OMB review and 

approval of a renewal for the 

information collection and 

recordkeeping requirements contained 

in the regulation codified at 42 CFR part 

52b. The purpose of the regulation is to 

govern the awarding and administration 

of grants awarded by NIH and its 

components for construction of new 

buildings and the alteration, renovation, 

remodeling, improvement, expansion, 

and repair of existing buildings, 

including the provision of equipment 

necessary to make the buildings (or 

applicable part of the buildings) suitable 

for the purpose for which it was 

constructed. In terms of reporting 

requirements: Section 52b.9(b) of the 

regulation requires the transferor of a 

facility which is sold or transferred, or 

owner of a facility, the use of which has 

changed, to provide written notice of 

the sale, transfer or change within 30 

days. Section 52b.10(f) requires a 

grantee to submit an approved copy of 

the construction schedule prior to the 

start of construction. Section 52b.10(g) 

requires a grantee to provide daily 

construction logs and monthly status 

reports upon request at the job site. 

Section 52b.11(b) requires applicants for 

a project involving the acquisition of 

existing facilities to provide the 

estimated cost of the project, cost of the 

acquisition of existing facilities, and 

cost of remodeling, renovating, or 

altering facilities to serve the purposes 

for which they are acquired. In terms of 

recordkeeping requirements: Section 

52b.10(g) requires grantees to maintain 

daily construction logs and monthly 

status reports at the job site. Frequency 

of Response: On occasion. Affected 

Public: Non-profit organizations and 

Federal agencies. Type of respondents: 

Grantees. The estimated respondent 

burden is as follows: 


Emcdonald on DSK2BSOYB1PROD with NOTICES