18242 Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5218, 

MSC 7852, Bethesda, MD 20892, 301–435– 

1775, rubertm@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(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: March 30, 2015. 

Melanie J. Gray, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–07628 Filed 4–2–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60 Day–15–0576; Docket No. CDC–2015– 

0013] 

Proposed Data Collection Submitted 

for Public Comment and 

Recommendations 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), as part of 

its continuing efforts to reduce public 

burden and maximize the utility of 

government information, invites the 

general public and other Federal 

agencies to take this opportunity to 

comment on proposed and/or 

continuing information collections, as 

required by the Paperwork Reduction 

Act of 1995. This notice invites 

comment on a proposed revision of the 

information collection entitled 

Possession, Use, and Transfer of Select 

Agents and Toxins (OMB Control No. 

0920–0576). CDC is requesting Office of 

Management and Budget (OMB) 

approval to continue to collect 

information under the select agent 

regulations through the use of five 

forms: (1) Application for Registration 

for Possession. Use, and Transfer of 

Select Agents and Toxins (APHIS/CDC 

Form 1); (2) Request to Transfer Select 

Agents or Toxins (APHIS/CDC Form 2); 

(3) Incident Form to Report Potential 

Theft, Loss, Release, or Occupational 

Exposure (APHIS/CDC Form 3); (4) 

Report of Identification of Select Agent 

or Toxin from Clinical/Diagnostic 

Specimen, Proficiency Testing, or 

Seizure by Federal Law Enforcement 

(APHIS/CDC Form 4); and (5) Request 

for Exemption of Select Agents and 

Toxins for an Investigational Product 

(APHIS/CDC Form 5). 

DATES: Written comments must be 

received on or before June 2, 2015. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2015– 

0013 by any of the following methods: 

• Federal eRulemaking Portal: 

Regulation.gov. Follow the instructions 

for submitting comments. 

• Mail: Leroy A. Richardson, 

Information Collection Review Office, 

Centers for Disease Control and 

Prevention, 1600 Clifton Road NE., MS– 

D74, Atlanta, Georgia 30329. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. All relevant comments 

received will be posted without change 

to Regulations.gov, including any 

personal information provided. For 

access to the docket to read background 

documents or comments received, go to 

Regulations.gov. 

Please note: All public comment should be 

submitted through the Federal eRulemaking 

portal (Regulations.gov) or by U.S. mail to the 

address listed above. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the information collection plan and 

instruments, contact the Information 

Collection Review Office, Centers for 

Disease Control and Prevention, 1600 

Clifton Road NE., MS–D74, Atlanta, 

Georgia 30329; phone: 404–639–7570; 

Email: omb@cdc.gov. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), Federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. In addition, the PRA also 

requires Federal agencies to provide a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each new 

proposed collection, each proposed 

extension of existing collection of 

information, and each reinstatement of 

previously approved information 

collection before submitting the 

collection to OMB for approval. To 

comply with this requirement, we are 

publishing this notice of a proposed 

data collection as described below. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology; and (e) estimates of capital 

or start-up costs and costs of operation, 

maintenance, and purchase of services 

to provide information. Burden means 

the total time, effort, or financial 

resources expended by persons to 

generate, maintain, retain, disclose or 

provide information to or for a Federal 

agency. This includes the time needed 

to review instructions; to develop, 

acquire, install and utilize technology 

and systems for the purpose of 

collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information, to search 

data sources, to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. 

Proposed Project 

Possession, Use, and Transfer of 

Select Agents and Toxins (OMB Control 

No. 0920–0576, Expiration—11/30/

2015)—Revision—Office of Public 

Health Preparedness and Response 

(OPHPR), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

Subtitle A of the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002, (42 U.S.C. 

262a), requires the United States 

Department of Health and Human 

Services (HHS) to regulate the 

possession, use, and transfer of 

biological agents or toxins that have the 

potential to pose a severe threat to 

public health and safety (select agents 

and toxins). Subtitle B of the Public 

Health Security and Bioterrorism 

Preparedness and Response Act of 2002 

(which may be cited as the Agricultural 

Bioterrorism Protection Act of 2002), (7 

U.S.C. 8401), requires the United States 

Department of Agriculture (USDA) to 

regulate the possession, use, and 

transfer of biological agents or toxins 

that have the potential to pose a severe 

threat to animal or plant health, or 

animal or plant products (select agents 

and toxins). Accordingly, HHS and 

USDA have promulgated regulations 

requiring individuals or entities that 

possess, use, or transfer select agents 

and toxins to register with the CDC or 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices 18243 

the Animal and Plant Health Inspection 

Service (APHIS). See 42 CFR part 73, 7 

CFR part 331, and 9 CFR part 121 (the 

select agent regulations). The Federal 

Select Agent Program (FSAP) is the 

collaboration of the CDC, Division of 

Select Agents and Toxins (DSAT) and 

the APHIS Agriculture Select Agent 

Services (AgSAS) to administer the 

select agent regulations in a manner to 

minimize the administrative burden on 

persons subject to the select agent 

regulations. The FSAP administers the 

select agent regulations in close 

coordination with the Federal Bureau of 

Investigation’s Criminal Justice 

Information Services (CJIS). 

Accordingly, CDC and APHIS have 

adopted an identical system to collect 

information for the possession, use, and 

transfer of select agents and toxins. 

CDC is requesting OMB approval to 

continue to collect information under 

the select agent regulations through the 

use of five forms: (1) Application for 

Registration for Possession. Use, and 

Transfer of Select Agents and Toxins 

(APHIS/CDC Form 1); (2) Request to 

Transfer Select Agents or Toxins 

(APHIS/CDC Form 2); (3) Incident Form 

to Report Potential Theft, Loss, Release, 

or Occupational Exposure (APHIS/CDC 

Form 3); (4) Report of Identification of 

Select Agent or Toxin from Clinical/

Diagnostic Specimen, Proficiency 

Testing, or Seizure by Federal Law 

Enforcement (APHIS/CDC Form 4); and 

(5) Request for Exemption of Select 

Agents and Toxins for an Investigational 

Product (APHIS/CDC Form 5). 

An entity may amend its registration 

(42 CFR 73.7(h)(1)) if any changes occur 

to the information previously submitted 

to CDC. When applying for an 

amendment to a certificate of 

registration, an entity would complete 

the relevant portion of the application 

package (APHIS/CDC Form 1). 

Besides the forms listed above, there 

is no standard form for the following 

information: 

1. An individual or entity may request 

an exclusion from the requirements of 

the select agent regulations of an 

attenuated strain of a select agent or a 

select toxin modified to be less potent 

or toxic. (42 CFR 73.3(e) and 73.4(e)). 

2. Annual inspections that are 

conducted by the entity must be 

documented. (42 CFR 73.9(a)(6)). 

3. An individual’s security risk 

assessment may be expedited upon 

written request by a Responsible Official 

and a showing of good cause. (42 CFR 

73.10(f)). 

4. An individual or entity may request 

approval to perform a ‘‘restricted 

experiment’’ (42 CFR 73.13). 

5. An individual or entity must 

develop and implement a written 

security plan, biosafety plan, and 

incident response plan (42 CFR 73.11(a), 

42 CFR 73.12(a), and 42 CFR 73.14(a)). 

6. The Responsible Official at the 

must ensure a record of the training for 

each individual with access to select 

agents and toxins and each escorted 

individual is maintained (42 CFR 

73.15(d)). 

7. An individual or entity may appeal 

a denial, revocation, or suspension of 

registration. (42 CFR 73.20(a)). 

8. An individual may appeal a denial, 

limitation, or revocation of access 

approval. (42 CFR 73.20(b)). 

The total estimated annualized 

burden for all data collection was 

calculated using data obtained from the 

FSAP database and is estimated as 8,528 

hours. Information will be collected via 

fax, email and hard copy mail from 

respondents. Upon OMB approval, CDC 

will begin use of the revised forms in 

November 2015 through November 

2018. There is no cost to the 

respondents. 

ESTIMATED ANNUALIZED BURDEN HOURS

Section Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

73.3 & 73.4 ....... Request for Exclusions ..................................................... 3 1 1 3 

73.5 & 6 ............ Report of Identification of a Select Agent or Toxin .......... 303 3 1 909 

73.5 & 73.6 ....... Request of Exemption ...................................................... 1 1 1 1 

73.7 ................... Application for Registration .............................................. 5 1 5 25 

73.7 ................... Amendment to a Certificate of Registration ..................... 277 7 1 1,939 

73.9 ................... Documentation of self-inspection ..................................... 277 1 1 277 

73.10 ................. Request for Expedited Review ......................................... 1 1 30/60 1 

73.11 ................. Security Plan .................................................................... 277 1 5 1,385 

73.12 ................. Biosafety Plan ................................................................... 277 1 5 1,385 

73.13 ................. Request Regarding a Restricted Experiment ................... 20 2 1 40 

73.14 ................. Incident Response Plan ................................................... 277 1 5 1,385 

73.15 ................. Training ............................................................................. 277 1 1 277 

73.16 ................. Request to Transfer Select Agents and Toxins ............... 156 2 1 312 

73.17 ................. Records ............................................................................ 277 1 30/60 139 

73.19 ................. Notification of Theft, Loss, or Release ............................. 215 2 1 430 

73.20 ................. Administrative Review ...................................................... 5 4 1 20 

Total ........... ........................................................................................... ........................ ........................ ........................ 8,528 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2015–07606 Filed 4–2–15; 8:45 am] 

BILLING CODE 4163–18–P 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
18244 Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–2187] 

Identifying Potential Biomarkers for 

Qualification and Describing Contexts 

of Use To Address Areas Important to 

Drug Development; Extension of 

Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; extension of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA) is extending the 

comment period for the notice entitled 

‘‘Identifying Potential Biomarkers for 

Qualification and Describing Contexts of 

Use to Address Areas Important to Drug 

Development; Request for Comments’’ 

that appeared in the Federal Register of 

February 13, 2015 (80 FR 8089). In the 

notice, FDA requested comments on 

identifying potential biomarkers for 

qualification and describing contexts of 

use to address areas important to drug 

development. The Agency is taking this 

action for an extension to allow 

interested persons additional time to 

submit comments. 

DATES: Submit either electronic or 

written comments by May 15, 2015 

ADDRESSES: Submit electronic 

comments 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: 

Marianne Noone, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 21, Rm. 4528, 

Silver Spring, MD 20993–0002, 301– 

796–7495. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of February 

13, 2015 (80 FR 8089), FDA published 

a notice with a 60-day comment period 

to request comments on identifying 

potential biomarkers for qualification 

and describing contexts of use to 

address areas important to drug 

development. FDA is encouraging 

interested groups and individuals to 

submit information on specific medical 

and biological areas where novel 

biomarkers can be identified that would 

meaningfully advance drug 

development. 

The current 60-day comment period 

does not allow sufficient time to obtain 

the broad public response that will 

inform FDA’s Biomarker Qualification 

Program going forward. FDA is 

extending the comment period for an 

additional 30 days, thus extending the 

comment period to May 15, 2015. The 

Agency believes that a 30-day extension 

allows adequate time for interested 

persons to submit comments without 

significantly delaying progress on these 

important issues. 

II. Request for Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

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, and 

will be posted to the docket at http:// 

www.regulations.gov. 

Dated: March 30, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07631 Filed 4–2–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Clinical Laboratory Improvement 

Advisory Committee 

Correction: This notice was published 

in the Federal Register on March 24, 

2015, Volume 80, Number 56, Pages 

15621–15622. The times and dates 

should read as follows: 

Times and Dates: 12:30 p.m.—5:00 

p.m., April 15, 2015; 8:30 a.m.—12:00 

p.m., April 16, 2015. 

CONTACT PERSON FOR ADDITIONAL

INFORMATION: Nancy Anderson, Chief, 

Laboratory Practice Standards Branch, 

Division of Laboratory Programs, 

Standards, and Services, Center for 

Surveillance, Epidemiology and 

Laboratory Services, Office of Public 

Health Scientific Services, CDC, 1600 

Clifton Road NE., Mailstop F–11, 

Atlanta, Georgia 30329–4018; telephone 

(404) 498–2741; or via email at 

NAnderson@cdc.gov 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Catherine Ramadei, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. 2015–07639 Filed 4–2–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HOMELAND 

SECURITY 

United States Immigration and 

Customs Enforcement 

Agency Information Collection 

Activities: Extension, With Change, of 

an Existing Information Collection; 

Comment Request 

ACTION: 60-Day Notice of Information 

collection for review; I–312/I–312A; 

Designation of Attorney in Fact/

Revocation of Attorney In Fact; OMB 

Control No. 1653–0041. 

The Department of Homeland 

Security, U.S. Immigration and Customs 

Enforcement (ICE), is submitting the 

following information collection request 

for review and clearance in accordance 

with the Paperwork Reduction Act of 

1995. The information collection is 

published in the Federal Register to 

obtain comments from the public and 

affected agencies. Comments are 

encouraged and will be accepted for 

sixty days until June 2, 2015. 

Written comments and suggestions 

regarding items contained in this notice 

and especially with regard to the 

estimated public burden and associated 

response time should be directed to the 

Department of Homeland Security 

(DHS), Scott Elmore, Forms 

Management Office, U.S. Immigration 

and Customs Enforcement, 801 I Street 

NW., Mailstop 5800, Washington, DC 

20536–5800. 

Written comments and suggestions 

from the public and affected agencies 

concerning the proposed collection of 

information should address one or more 

of the following four points: 

(1) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 


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