Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices 78249 

building no later than 9 a.m. e.s.t. to 

allow for enough time to clear security 

and to check in before the meeting 

begins. The on-site check-in for visitors 

will begin at 9:30 a.m. e.s.t. All items 

brought to the building, whether 

personal or for the purpose of 

demonstration or to support a 

presentation, including items such as 

laptops, cell phones, and palm pilots, 

are subject to physical inspection. 

Security measures include the 

following: 

• Presentation of government-issued 

photographic identification to the 

Federal Protective Service or Guard 

Service personnel. 

• Interior and exterior inspection of 

vehicles (this includes engine and trunk 

inspection) at the entrance to the 

grounds. Parking permits and 

instructions will be issued after the 

vehicle inspection. 

• Passing through a metal detector 

and inspection of items brought into the 

building. 

We note that all items brought to 

CMS, whether personal or for the 

purpose of demonstration or to support 

a demonstration, are subject to 

inspection. We cannot assume 

responsibility for coordinating the 

receipt, transfer, transport, storage, 

setup, safety, or timely arrival of any 

personal belongings or items used for 

demonstration or to support a 

demonstration. 

Note: Individuals who are not registered in 

advance will not be permitted to enter the 

building and will be unable to attend the 

meeting. The public may not enter the 

building earlier than 45 minutes prior to the 

convening of the meeting. All visitors must be 

escorted in areas other than the lower and 

first floor levels in the Central Building. 

Seating capacity is limited to the first 250 

registrants. 

Authority: Section 503 of Public Law 108– 

173. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program). 

Dated: December 7, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2010–31301 Filed 12–13–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0008] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry on Citizen Petitions and 

Petitions for Stay of Action Subject to 

Section 505(q) of the Federal Food, 

Drug, and Cosmetic Act 

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 

(PRA). 

DATES: Fax written comments on the 

collection of information by January 14, 

2011. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910—NEW and 

title ‘‘Guidance for Industry on Citizen 

Petitions and Petitions for Stay of 

Action Subject to Section 505(q) of the 

Federal Food, Drug, and Cosmetic Act.’’ 

Also include the FDA docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850. 301– 

796–3792. E-mail: 

elizabeth.berbakos@fda.hhs.gov. 

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. 

Guidance for Industry on Citizen 

Petitions and Petitions for Stay of 

Action Subject to Section 505(q) of the 

Federal Food, Drug, and Cosmetic Act 

In the Federal Register of January 21, 

2009 (74 FR 3611), FDA announced the 

availability of a draft guidance for 

industry entitled ‘‘Draft Guidance for 

Industry on Citizen Petitions and 

Petitions for Stay of Action Subject to 

Section 505(q) of the Federal Food, 

Drug, and Cosmetic Act’’ (FD&C Act). 

FDA is now in the process of finalizing 

this guidance. In that Federal Register 

notice, FDA provided the public with 60 

days to comment on the proposed 

collection of information. FDA received 

no comments pertaining to the 

information collection in the draft 

guidance. 

Description of Respondents: 

Respondents to this collection of 

information as it is related to citizen 

petitions are individuals or households, 

State or local governments, not-forprofit institutions, and businesses or 

other for-profit institutions or groups. 

Respondents to this collection of 

information as it is related to petitions 

for stay of Agency action are persons 

who choose to file a petition for an 

administrative stay of action. 

Burden Estimate: Section 505(q)(1)(H) 

of the FD&C Act requires that citizen 

petitions and petitions for stay of 

Agency action that are subject to section 

505(q) include a certification to be 

considered for review by FDA. Section 

505(q)(1)(I) of the FD&C Act requires 

that supplemental information or 

comments to such citizen petitions and 

petitions for stay of Agency action 

include a verification to be accepted for 

review by FDA. This guidance describes 

our current thinking on the 

interpretation of these requirements. 

The guidance sets forth the criteria the 

Agency will use in determining if the 

provisions of section 505(q) apply to a 

particular citizen petition or petition for 

stay of agency action. One of the criteria 

for a citizen petition or petition for stay 

of Agency action to be subject to section 

505(q) of the FD&C Act is that a related 

ANDA or 505(b)(2) application is 

pending at the time the citizen petition 

or petition for stay is submitted. 

Because petitioners or commenters may 

not be aware of the existence of a 

pending ANDA or 505(b)(2) application, 

the guidance recommends that all 

petitioners challenging the 

approvability of a possible ANDA or 

505(b)(2) application include the 

certification required in section 

505(q)(1)(H) of the FD&C Act and that 

petitioners and commenters submitting 

supplements or comments, respectively, 

to a citizen petition or petition for stay 

of action challenging the approvability 

of a possible ANDA or 505(b)(2) 

application include the verification 

required in section 505(q)(1)(I) of the 

FD&C Act. The guidance also 

recommends that if a petitioner submits 

a citizen petition or petition for stay of 

Agency action that is missing the 


hsrobinson on DSK69SOYB1PROD with NOTICES
78250 Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices 

required certification but is otherwise 

within the scope of section 505(q) of the 

FD&C Act and the petitioner would like 

FDA to review the citizen petition or 

petition for stay of Agency action, the 

petitioner should submit a letter 

withdrawing the deficient petition and 

submit a new petition that contains the 

required certification. 

FDA currently has OMB approval for 

the collection of information entitled, 

‘‘General Administrative Procedures: 

Citizen Petitions; Petition for 

Reconsideration or Stay of Action; 

Advisory Opinions’’ (OMB Control 

Number 0910–0183). This collection of 

information includes, among other 

things: (1) The format and procedures 

by which an interested person may 

submit to FDA, in accordance with 

§ 10.20 (21 CFR 10.20), a citizen petition 

requesting the Commissioner of Food 

and Drugs (Commissioner) to issue, 

amend, or revoke a regulation or order, 

or to take or refrain from taking any 

other form of administrative action 

(§ 10.30(b) (21 CFR 10.30(b))); (2) the 

submission of written comments on a 

filed citizen petition (§ 10.30(d)); (3) the 

submission of a supplement or 

amendment to or a letter to withdraw a 

filed citizen petition (§ 10.30(g)); (4) the 

format and procedures by which an 

interested person may request, in 

accordance with § 10.20, the 

Commissioner to stay the effective date 

of any administrative action (§ 10.35(b) 

(21 CFR 10.35(b))); and (5) the 

submission of written comments on a 

filed petition for administrative stay of 

action (§ 10.35(c)). This information 

collection includes citizen petitions, 

petitions for administrative stay of 

action, comments to petitions, 

supplements to citizen petitions, and 

letters to withdraw a citizen petition, as 

described previously in this document, 

that are subject to section 505(q) of the 

FD&C Act and described in the 

guidance. 

Under section 505(q) of the FD&C Act 

and the guidance, the following 

information would be submitted to FDA 

but is not currently approved by OMB 

under the PRA: 

1. The certification required under 

section 505(q)(1)(H) of the FD&C Act for 

citizen petitions that are subject to 

section 505(q) and/or that are 

challenging the approvability of a 

possible ANDA or 505(b)(2) application. 

Although the submission of a 

certification for citizen petitions is 

approved under OMB Control Number 

0910–0183, the certification would be 

broadened under section 505(q) of the 

FD&C Act and the guidance. 

2. The certification required under 

section 505(q)(1)(H) of the FD&C Act for 

petitions for stay of Agency action that 

are subject to section 505(q) and/or that 

are challenging the approvability of a 

possible ANDA or 505(b)(2) application. 

3. The verification required under 

section 505(q)(1)(I) of the FD&C Act for 

comments to citizen petitions. 

4. The verification required under 

section 505(q)(1)(I) of the FD&C Act for 

comments to petitions for stay of 

Agency action. 

5. The verification required under 

section 505(q)(1)(I) of the FD&C Act for 

supplements to citizen petitions. 

6. Supplements to petitions for stay of 

Agency action. 

7. The verification required under 

section 505(q)(1)(I) of the FD&C Act for 

supplements to petitions for stay of 

Agency action. 

8. The letter submitted by a petitioner 

withdrawing a deficient petition for stay 

of Agency action that is missing the 

required certification but is otherwise 

within the scope of section 505(q) of the 

FD&C Act. 

Section 505(q)(1)(B) and (C) of the 

FD&C Act and the guidance state that if 

FDA determines that a delay in approval 

of an ANDA or 505(b)(2) application is 

necessary based on a petition subject to 

section 505(q), the applicant may 

submit to the petition docket 

clarifications or additional data to allow 

FDA to review the petition promptly. 

This information collection is not 

included in this analysis because it is 

approved under OMB Control Number 

0910–0001 (21 CFR 314.54, 314.94, and 

314.102). 

Based on FDA’s knowledge of citizen 

petitions and petitions for stay of 

Agency action subject to section 505(q) 

of the FD&C Act that have been 

submitted to FDA, as well as the 

Agency’s familiarity with the time 

needed to prepare a supplement, a 

certification, and a verification. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of 

respondents 

Annual 

frequency per 

response 

Total 

annual 

responses 

Hours per 

response Total hours 

Certification for citizen petitions (505(q)(1)(H)) ......... 19 1 .32 25 0.5 12 .5 

Certification for petitions for stay of Agency action 

(505(q)(1)(H)) ......................................................... 3 1 3 0.5 1 .5 

Verification for comments to citizen petitions 

(505(q)(1)(I)) ........................................................... 9 1 .33 12 0.5 6 .0 

Verification for comments to petitions for stay of 

Agency action (505(q)(1)(I)) ................................... 2 1 2 0.5 1 .0 

Verification for supplements to citizen petitions 

(505(q)(1)(I)) ........................................................... 7 1 .43 10 0.5 5 .0 

Supplements to petitions for stay of Agency action .. 1 1 1 6.0 6 .0 

Verification for supplements to petitions for stay of 

Agency action (505(q)(1)(I)) ................................... 1 1 1 0.5 0 .5 

Letter withdrawing a petition for stay of Agency action .......................................................................... 1 1 1 0.5 0 .5 

Total Hours ......................................................... 33 

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


hsrobinson on DSK69SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices 78251 

Dated: December 8, 2010. 

Leslie Kux, 

Acting Assistant, Commissioner for Policy. 

[FR Doc. 2010–31380 Filed 12–14–10; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0380] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Generic Food and 

Drug Administration Rapid Response 

Surveys 

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 14, 

2011. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0500. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850. 301–796– 

5156. Daniel.Gittleson@fda.hhs.gov. 

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. 

Generic Food and Drug Administration 

Rapid Response Surveys—(OMB 

Control Number 0910–0500)—Extension 

Section 505 of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 355), requires that important 

safety information relating to all human 

prescription drug products be made 

available to FDA so that it can take 

appropriate action to protect the public 

health when necessary. Section 702 of 

the FD&C Act (21 U.S.C. 372) authorizes 

investigational powers to FDA for 

enforcement of the FD&C Act. Under 

section 519 of the FD&C Act (21 U.S.C. 

360i), FDA is authorized to require 

manufacturers to report medical devicerelated deaths, serious injuries, and 

malfunctions to FDA; to require user 

facilities to report device-related deaths 

directly to FDA and to manufacturers; 

and to report serious injuries to the 

manufacturer. Section 522 of the FD&C 

Act (21 U.S.C. 360l) authorizes FDA to 

require manufacturers to conduct 

postmarket surveillance of medical 

devices. Section 705(b) of the FD&C Act 

(21 U.S.C. 375(b)) authorizes FDA to 

collect and disseminate information 

regarding medical products or cosmetics 

in situations involving imminent danger 

to health or gross deception of the 

consumer. Section 903(d)(2) of the 

FD&C Act (21 U.S.C. 393(d)(2)) 

authorizes the Commissioner of Food 

and Drugs to implement general powers 

(including conducting research) to carry 

out effectively the mission of FDA. 

These sections of the FD&C Act enable 

FDA to enhance consumer protection 

from risks associated with medical 

products usage that are not foreseen or 

apparent during the premarket 

notification and review process. FDA’s 

regulations governing application for 

Agency approval to market a new drug 

(21 CFR part 314) and regulations 

governing biological products (21 CFR 

part 600) implement these statutory 

provisions. Currently, FDA monitors 

medical product related postmarket 

adverse events via both the mandatory 

and voluntary MedWatch reporting 

systems using FDA Forms 3500 and 

3500A (OMB control number 0910– 

0291) and the vaccine adverse event 

reporting system. FDA is seeking OMB 

clearance to collect vital information via 

a series of rapid response surveys. 

Participation in these surveys will be 

voluntary. This request covers rapid 

response surveys for community based 

health care professionals, general type 

medical facilities, specialized medical 

facilities (those known for cardiac 

surgery, obstetrics/gynecology services, 

pediatric services, etc.), other health 

care professionals, patients, consumers, 

and risk managers working in medical 

facilities. FDA will use the information 

gathered from these surveys to obtain 

quickly vital information about medical 

product risks and interventions to 

reduce risks so the Agency may take 

appropriate public health or regulatory 

action including dissemination of this 

information as necessary and 

appropriate. 

FDA projects 6 emergency risk related 

surveys per year with a sample of 

between 50 and 10,000 respondents per 

survey. FDA also projects a response 

time of 0.5 hours per response. These 

estimates are based on the maximum 

sample size per questionnaire that FDA 

may be able to obtain by working with 

health care professional organizations. 

The annual number of surveys was 

determined by the maximum number of 

surveys per year FDA has ever 

conducted under this collection. 

In the Federal Register of August 6, 

2010 (75 FR 47599), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response 

Total 

hours 

10,000 .............................................................................................................. 2 6 60,000 .5 30,000 

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

2 Maximum. 


hsrobinson on DSK69SOYB1PROD with NOTICES