Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Notices 50741 

Act to expand the situations in which 

FDA may order postmarket surveillance 

and allow longer surveillance periods in 

certain circumstances. This guidance 

document is intended to assist device 

manufacturers subject to a section 522 

postmarket surveillance order by 

providing an overview of section 522 of 

the FD&C Act, procedural information 

on how to fulfill section 522 obligations, 

and recommendations on the format, 

content, and review of postmarket 

surveillance study submissions. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on ‘‘Procedures for Handling Section 

522 Postmarket Surveillance Studies.’’ It 

does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by using 

the Internet. A search capability for all 

CDRH guidance documents is available 

at http://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. To 

receive ‘‘Procedures for Handling 

Section 522 Postmarket Surveillance 

Studies’’ you may either send an e-mail 

request to dsmica@fda.hhs.gov to 

receive an electronic copy of the 

document or send a fax request to 301– 

847–8149 to receive a hard copy. Please 

use the document number 1754 to 

identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These 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 822 have 

been approved under OMB control 

number 0910–0449. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: August 10, 2011. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2011–20727 Filed 8–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

2011 Parenteral Drug Association/Food 

and Drug Administration Joint Public 

Conference; Quality and Compliance in 

Today’s Regulatory Enforcement 

Environment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public conference. 

The Food and Drug Administration 

(FDA), in cosponsorship with Parenteral 

Drug Association (PDA), is announcing 

a public conference entitled ‘‘Quality 

and Compliance in Today’s Regulatory 

Enforcement Environment.’’ The 

conference will span 21⁄2 days and cover 

current issues affecting the industry as 

well as explore strategies and 

approaches for ensuring conformance 

with regulations to facilitate the 

development and continuous 

improvement of safe and effective 

medical products. The conference 

establishes a unique forum to discuss 

the foundations, emerging technologies 

and innovations in regulatory science, 

as well as the current quality and 

compliance areas of concerns. Meeting 

participants will hear from FDA and 

industry speakers about the 

requirements and best practices to 

consider while implementing robust 

quality systems in order to deliver the 

best quality product. 

Date and Time: The public conference 

will be held on September 19, 2011, 

from 7 a.m. to 6 p.m.; September 20, 

2011, from 7:30 a.m. to 6:15 p.m.; and 

September 21, 2011, from 7:30 a.m. to 

12:15 p.m. 

Location: The public conference will 

be held at the Renaissance Hotel, 999 

Ninth St., NW., Washington, DC 20001, 

202–898–9000, FAX: 202–289–0947. 

Contact: Wanda Neal, Parenteral Drug 

Association, PDA Global Headquarters, 

Bethesda Towers, 4350 East West Hwy., 

suite 200, Bethesda, MD 20814, 301– 

656–5900, FAX: 301–986–1093, e-mail: 

info@pda.org. 

Accommodations: Attendees are 

responsible for their own 

accommodations. To make reservations 

at the Renaissance Hotel at the reduced 

conference rate, contact the Renaissance 

Hotel (see Location)—cite the meeting 

code ‘‘PDA.’’ Room rates are: Single: 

$288, plus 14.5% state and local taxes 

and Double: $288, plus 14.5 percent 

state and local taxes. Reservations can 

be made on a space and rate availability 

basis. 

Registration: Attendees are 

encouraged to register at their earliest 

convenience. The PDA registration fees 

cover the cost of facilities, materials, 

and refreshments. Seats are limited; 

please submit your registration as soon 

as possible. Conference space will be 

filled in order of receipt of registration. 

Those accepted for the conference will 

receive confirmation. Registration will 

close after the conference is filled. 

Onsite registration will be available on 

a space available basis on each day of 

the public conference beginning at 7 

a.m. on September 19, 2011. The cost of 

registration is as follows: 

COST OF REGISTRATION

Affiliation Fee 

PDA Members .............................. $1,895 

NonMembers ................................ 2,144 

PDA Member Government/Health 

Authority .................................... 700 

NonMember Government/Health 

Authority .................................... 800 

PDA Member Academic ............... 700 

NonMember Academic ................. 780 

PDA Member Students ................. 280 

NonMember Students ................... 310 

Please visit PDA’s Web site: http:// 

www.pda.org/pdafda2011 to confirm 

the prevailing registration fees. (FDA 

has verified the Web site address, but 

FDA is not responsible for any 

subsequent changes to the Web site after 

this document publishes in the Federal 

Register.) 

If you need special accommodations 

due to a disability, please contact 

Wanda Neal (see Contact), at least 7 

days in advance of the conference. 

Registration Instructions: To register, 

please submit your name, affiliation, 

mailing address, telephone, fax number, 

and e-mail address, along with a check 

or money order payable to ‘‘PDA.’’ Mail 

to: PDA, Global Headquarters, Bethesda 

Towers, 4350 East West Hwy., suite 200, 

Bethesda, MD 20814. To register via the 


emcdonald on DSK2BSOYB1PROD with NOTICES
50742 Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Notices 

Internet, go to PDA’s Web site: http:// 

www.pda.org/pdafda2011. 

The registrar will also accept payment 

by major credit cards (VISA/American 

Express/MasterCard only). For more 

information on the meeting, or for 

questions on registration, contact PDA 

(see Contact). 

Transcripts: As soon as a transcript is 

available, it can be obtained in either 

hardcopy or on CD–ROM, after 

submission of a Freedom of Information 

request. Written requests are to be sent 

to Division of Freedom of Information 

(ELEM–1029), Food and Drug 

Administration, 12420 Parklawn Dr., 

Element Bldg., Rockville, MD 20857. 

SUPPLEMENTARY INFORMATION: The PDA/ 

FDA joint public conference offers the 

unique opportunity for participants to 

join FDA representatives and industry 

experts in face-to-face dialogues. Each 

year, FDA speakers provide updates on 

current efforts affecting the 

development of global regulatory 

strategies, while industry professionals 

from some of today’s leading 

pharmaceutical companies present case 

studies on how they employ global 

strategies in their daily processes. 

Through a series of sessions and 

meetings, the conference will provide 

participants with the opportunity to 

hear directly from FDA experts and 

representatives of global regulatory 

authorities on best practices, including: 

• Accountability in a Global 

Environment—Enforcement and Supply 

Chain 

• Office of International Programs 101 

& Foreign Inspections 

• International Conference on 

Harmonization Q11 

• New Regulations—Status Update 

• First Cycle Review 

• Drug Safety 

• Good Inspection Practices— 

Domestic 

• Process Validation 

• Emerging Regulations for Positron 

Emission Tomography 

• FDA/Pharmaceutical Inspection Cooperation Scheme 

• Standards 

• International Compliance Update 

• Good Manufacturing Practice Life 

Cycle 

• Supply Chain 

To help ensure the quality of FDAregulated products, the 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 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 11, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–20791 Filed 8–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Member 

Conflict: Cardiovascular Sciences 

Dates: September 9, 2011 

Time: 1 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Yuanna Cheng, MD, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4138, 

MSC 7814, Bethesda, MD 20892, (301)435– 

1195, Chengy5@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Social 

Science and Population Studies: Second 

Panel. 

Dates: September 19, 2011. 

Time: 8:30 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Melrose Hotel, 2430 Pennsylvania 

Ave., NW., Washington, DC 20037. 

Contact Person: Suzanne Ryan, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3139, 

MSC 7770, Bethesda, MD 20892, (301) 435– 

1712, ryansj@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: August 9, 2011. 

Anna P. Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–20829 Filed 8–15–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

T35 Training Grant in Pediatric Respiratory, 

Sleep, and Transfusion Medicine. 

Date: September 7, 2011. 

Time: 2 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Stephanie L Constant, 

PhD, Scientific Review Officer, Office of 

Scientific Review/DERA, National Heart, 

Lung, and Blood Institute, 6701 Rockledge 

Drive, Room 7189, Bethesda, MD 20892, 301– 

443–8784, constantsl@nhlbi.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: August 10, 2011. 

Anna P. Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–20845 Filed 8–15–11; 8:45 am] 

BILLING CODE 4140–01–P 


emcdonald on DSK2BSOYB1PROD with NOTICES