Federal Register / Vol. 74, No. 201 / Tuesday, October 20, 2009 / Notices 53753 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2006–D–0157] (Formerly 

Docket No. 2006D–0514) 

Guidance for Industry: Minimally 

Manipulated, Unrelated Allogeneic 

Placental/Umbilical Cord Blood 

Intended for Hematopoietic 

Reconstitution for Specified 

Indications; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance document 

entitled ‘‘Guidance for Industry: 

Minimally Manipulated, Unrelated 

Allogeneic Placental/Umbilical Cord 

Blood Intended for Hematopoietic 

Reconstitution for Specified 

Indications,’’ dated October 2009. In 

this guidance, we refer to these products 

for hematopoietic reconstitution for 

specified indications as hematopoietic 

progenitor cells, cord (HPC–C). This 

guidance (HPC–C licensure guidance) 

provides recommendations to 

manufacturers applying for licensure of 

minimally manipulated, unrelated 

allogeneic placental/umbilical cord 

blood, for specified indications. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a draft 

guidance entitled ‘‘Guidance for 

Industry and FDA Staff: Investigational 

New Drug Applications (INDs) for 

Minimally Manipulated, Unrelated 

Allogeneic Placental/Umbilical Cord 

Blood Intended for Hematopoietic 

Reconstitution for Specified 

Indications.’’ FDA is also announcing 

the end of the phased-in 

implementation period for IND and 

biologics license application (BLA) 

requirements for minimally 

manipulated unrelated allogeneic 

hematopoietic stem/progenitor cell 

products. The HPC–C licensure 

guidance announced in this notice 

finalizes the draft guidance entitled 

‘‘Guidance for Industry: Minimally 

Manipulated, Unrelated, Allogeneic 

Placental/Umbilical Cord Blood 

Intended for Hematopoietic 

Reconstitution in Patients with 

Hematological Malignancies,’’ dated 

December 2006. 

DATES: Submit electronic or written 

comments on agency guidances at any 

time. FDA no longer intends to exercise 

enforcement discretion with respect to 

IND and BLA requirements for 

minimally manipulated, unrelated 

allogeneic hematopoietic stem/ 

progenitor cell products and the phase 

in implementation period for IND and 

BLA requirements will end after 

October 20, 2011. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), 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 guidance may also be obtained by 

mail by calling CBER at 1–800–835– 

4709 or 301–827–1800. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Tami Belouin, 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 guidance document entitled 

‘‘Guidance for Industry: Minimally 

Manipulated, Unrelated Allogeneic 

Placental/Umbilical Cord Blood 

Intended for Hematopoietic 

Reconstitution for Specified 

Indications,’’ dated October 2009. This 

guidance provides recommendations to 

manufacturers applying for licensure of 

minimally manipulated, unrelated 

allogeneic placental/umbilical cord 

blood, for specified indications. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing an IND draft 

guidance entitled ‘‘Guidance for 

Industry and FDA Staff: Investigational 

New Drug Applications (INDs) for 

Minimally Manipulated, Unrelated 

Allogeneic Placental/Umbilical Cord 

Blood Intended for Hematopoietic 

Reconstitution for Specified 

Indications.’’ FDA is also announcing 

that it no longer intends to exercise 

enforcement discretion with respect to 

IND and BLA requirements for 

minimally manipulated unrelated 

allogeneic hematopoietic stem/ 

progenitor cell products and the phasein implementation period for IND and 

license application requirements for 

these products will end (see DATES for 

ending date). We encourage sponsors to 

send in applications as soon as possible 

to allow sufficient time for review, 

comment, and re-submission as needed 

to complete all actions by the end of this 

2-year period. 

In the Federal Register notice of 

January 20, 1998 (63 FR 2985), FDA 

requested submission of comments 

proposing establishment controls, 

process controls, and product standards 

designed to ensure the safety and 

effectiveness of minimally manipulated 

unrelated allogeneic hematopoietic 

stem/progenitor cell products derived 

from peripheral and cord blood for 

hematopoietic reconstitution. Also, in 

the January 20, 1998, notice, FDA 

announced its intention to phase in 

implementation of IND and license 

application requirements for minimally 

manipulated unrelated allogeneic 

hematopoietic stem/progenitor cell 

products to permit the development of 

licensing standards for those products 

where possible. 

In the Federal Register notice of 

January 17, 2007 (72 FR 1999), FDA 

announced the availability of the draft 

guidance entitled ‘‘Guidance for 

Industry: Minimally Manipulated, 

Unrelated, Allogeneic Placental/ 

Umbilical Cord Blood Intended for 

Hematopoietic Reconstitution in 

Patients with Hematological 

Malignancies,’’ dated December 2006. 

FDA received comments on the 

December 2006 draft guidance and those 

comments were considered as the 

guidance was finalized. The HPC–C 

licensure guidance announced in this 

notice finalizes the December 2006 draft 

guidance. Some of the comments 

received by FDA expressed the 

importance of access and availability of 

HPC–C products that not do meet 

standards for licensure and therefore 

cannot be licensed. FDA recognizes the 

importance of these products and is 

publishing a draft IND guidance 

addressing IND submissions for such 

products. 

This guidance is consistent with 

FDA’s good guidance practices 

regulation (21 CFR 10.115). The 

guidance represents FDA’s current 

thinking on these topics. It does not 

create or confer any rights for or on any 

person and does not operate to bind 

FDA or the public. Alternative 

approaches may be used if such 

approaches satisfy the requirements of 

the applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 


cprice-sewell on DSKGBLS3C1PROD with NOTICES
53754 Federal Register / Vol. 74, No. 201 / Tuesday, October 20, 2009 / Notices 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 201 have been approved 

under OMB Control No. 0910–0572; 21 

CFR part 211 have been approved under 

OMB Control No. 0910–0139; 21 CFR 

part 600 have been approved under 

OMB Control No. 0910–0308; 21 CFR 

parts 601, 610, and FDA Form 356(h) 

have been approved under OMB Control 

No. 0910–0338; 21 CFR part 1271 have 

been approved under OMB Control Nos. 

0910–0559, 0910–0469, and 0910–0543; 

and FDA Form 3500A has been 

approved under OMB Control No. 0910– 

0291. 

III. Comments 

Interested persons may, at any time, 

submit to the Division of Dockets 

Management (see ADDRESSES) electronic 

or written comments regarding the 

guidance. Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. A copy of the guidance and 

received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either http:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm or 

http://www.regulations.gov. 

Dated: October 14, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–25135 Filed 10–19–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–N–0270] 

Medical Device User Fee and 

Modernization Act; Notice to Public of 

Web Location of 2010 Proposed 

Guidance Development 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

Web location where it will post a list of 

guidance documents the Center for 

Devices and Radiological Health (CDRH) 

is considering for development. In 

addition, FDA has established a docket 

where stakeholders may provide 

comments and/or draft language for 

those topics as well as suggestions for 

new or different guidances. 

DATES: Submit written or electronic 

comments at any time. 

ADDRESSES: Submit written comments 

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.regulations.gov. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Myrna Hanna, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. WO66, rm. 4436, Silver 

Spring, MD 20993, 301–796–5739. 

SUPPLEMENTARY INFORMATION: 

I. Background 

During negotiations over the 

reauthorization of the Medical Device 

User Fee and Modernization Act 

(MDUFMA), FDA agreed, in return for 

additional funding from industry, to 

meet a variety of quantitative and 

qualitative goals intended to help get 

safe and effective medical devices to 

market more quickly. These 

commitments include annually posting 

a list of guidance documents that CDRH 

is considering for development and 

providing stakeholders an opportunity 

to provide comments and/or draft 

language for those topics, or suggestions 

for new or different guidances. This 

notice announces the Web location of 

the list of guidances on which CDRH is 

intending to work over the next fiscal 

year. We note that the agency is not 

required to issue every guidance on the 

list, nor is it precluded from issuing 

guidance documents that are not on the 

list. The list includes topics that 

currently have no guidance associated 

with them, topics where updated 

guidance may be helpful, and topics for 

which CDRH has already issued level 1 

drafts that may be finalized following 

review of public comments. We will 

consider stakeholder comments as we 

prioritize our guidance efforts. 

FDA and CDRH priorities are subject 

to change at any time. Topics on this 

and past guidance priority lists may be 

removed or modified based on current 

priorities. We also note that CDRH’s 

experience over the years has shown 

that there are many reasons CDRH staff 

does not complete the entire annual 

agenda of guidances it undertakes. Staff 

are frequently diverted from guidance 

development to other activities, 

including review of premarket 

submissions or postmarket problems. In 

addition, the Center is required each 

year to issue a number of guidances that 

it cannot anticipate at the time the 

annual list is generated. These may 

involve newly identified public health 

issues as well as special control 

guidance documents for de novo 

classifications of devices. It will be 

helpful, therefore, to receive comments 

that indicate the relative priority of 

different guidance topics to interested 

stakeholders. 

Through feedback from stakeholders, 

including draft language for guidance 

documents, CDRH expects to be able to 

better prioritize and more efficiently 

draft guidances that will be useful to 

industry and other stakeholders. This 

will be the third annual list CDRH has 

posted. FDA intends to update the list 

each year. 

FDA invites interested persons to 

submit comments on any or all of the 

guidance documents on the list. FDA 

has established a specific docket where 

comments about the fiscal year 2010 

list, draft language for guidance 

documents on those topics, and 

suggestions for new or different 

guidances may be submitted (see 

ADDRESSES). FDA believes this docket is 

an important tool for receiving 

information from interested parties and 

for sharing this information with the 

public. Similar information about 

planned guidance development is 

included in the annual agency-wide 

notice issued by FDA under its good 

guidance practices (21 CFR 10.115(f)(5)). 

This CDRH list, however, will be 

focused exclusively on device-related 

guidances and will be made available on 

FDA’s Web site prior to the beginning of 

each fiscal year from 2008 to 2012. 

To access the list of the guidance 

documents CDRH is considering for 

development in 2010, visit the FDA 

Web site http://www.fda.gov/ 

MedicalDevices/DeviceRegulation

andGuidance/Overview/ 

MedicalDeviceUser

FeeandModernizationActMDUFMA/ 

ucm109196.htm. 

II. Request for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 


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