80_FR_18306 80 FR 18242 - Proposed Data Collection Submitted for Public Comment and Recommendations

80 FR 18242 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 64 (April 3, 2015)

Page Range18242-18244
FR Document2015-07606

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).

Federal Register, Volume 80 Issue 64 (Friday, April 3, 2015) 
[Federal Register Volume 80, Number 64 (Friday, April 3, 2015)]
[Notices]
[Pages 18242-18244]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-07606]


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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.

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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: [email protected].

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

[[Page 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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
          Section                 Form name          Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
73.3 & 73.4...............  Request for                        3               1               1               3
                             Exclusions.
73.5 & 6..................  Report of                        303               3               1             909
                             Identification of a
                             Select Agent or
                             Toxin.
73.5 & 73.6...............  Request of Exemption               1               1               1               1
73.7......................  Application for                    5               1               5              25
                             Registration.
73.7......................  Amendment to a                   277               7               1           1,939
                             Certificate of
                             Registration.
73.9......................  Documentation of                 277               1               1             277
                             self-inspection.
73.10.....................  Request for                        1               1           30/60               1
                             Expedited Review.
73.11.....................  Security Plan.......             277               1               5           1,385
73.12.....................  Biosafety Plan......             277               1               5           1,385
73.13.....................  Request Regarding a               20               2               1              40
                             Restricted
                             Experiment.
73.14.....................  Incident Response                277               1               5           1,385
                             Plan.
73.15.....................  Training............             277               1               1             277
73.16.....................  Request to Transfer              156               2               1             312
                             Select Agents and
                             Toxins.
73.17.....................  Records.............             277               1           30/60             139
73.19.....................  Notification of                  215               2               1             430
                             Theft, Loss, or
                             Release.
73.20.....................  Administrative                     5               4               1              20
                             Review.
                           -------------------------------------------------------------------------------------
    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

18242 Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices Scientific Review, National Institutes of Seizure by Federal Law Enforcement agency’s estimate of the burden of the Health, 6701 Rockledge Drive, Room 5218, (APHIS/CDC Form 4); and (5) Request proposed collection of information; (c) MSC 7852, Bethesda, MD 20892, 301–435– for Exemption of Select Agents and ways to enhance the quality, utility, and 1775, rubertm@csr.nih.gov. Toxins for an Investigational Product clarity of the information to be This notice is being published less than 15 (APHIS/CDC Form 5). collected; (d) ways to minimize the days prior to the meeting due to the timing limitations imposed by the review and DATES: Written comments must be burden of the collection of information funding cycle. received on or before June 2, 2015. on respondents, including through the use of automated collection techniques (Catalogue of Federal Domestic Assistance ADDRESSES: You may submit comments, Program Nos. 93.306, Comparative Medicine; or other forms of information identified by Docket No. CDC–2015– 93.333, Clinical Research, 93.306, 93.333, technology; and (e) estimates of capital 0013 by any of the following methods: 93.337, 93.393–93.396, 93.837–93.844, or start-up costs and costs of operation, • Federal eRulemaking Portal: 93.846–93.878, 93.892, 93.893, National maintenance, and purchase of services Institutes of Health, HHS) Regulation.gov. Follow the instructions to provide information. Burden means for submitting comments. Dated: March 30, 2015. the total time, effort, or financial • Mail: Leroy A. Richardson, Melanie J. Gray, resources expended by persons to Information Collection Review Office, generate, maintain, retain, disclose or Program Analyst, Office of Federal Advisory Centers for Disease Control and Committee Policy. provide information to or for a Federal Prevention, 1600 Clifton Road NE., MS– agency. This includes the time needed [FR Doc. 2015–07628 Filed 4–2–15; 8:45 am] D74, Atlanta, Georgia 30329. to review instructions; to develop, BILLING CODE 4140–01–P Instructions: All submissions received acquire, install and utilize technology must include the agency name and and systems for the purpose of Docket Number. All relevant comments collecting, validating and verifying DEPARTMENT OF HEALTH AND received will be posted without change HUMAN SERVICES information, processing and to Regulations.gov, including any maintaining information, and disclosing Centers for Disease Control and personal information provided. For and providing information; to train Prevention access to the docket to read background personnel and to be able to respond to documents or comments received, go to a collection of information, to search [60 Day–15–0576; Docket No. CDC–2015– Regulations.gov. 0013] data sources, to complete and review Please note: All public comment should be the collection of information; and to Proposed Data Collection Submitted submitted through the Federal eRulemaking transmit or otherwise disclose the portal (Regulations.gov) or by U.S. mail to the information. for Public Comment and address listed above. Recommendations Proposed Project AGENCY: Centers for Disease Control and FOR FURTHER INFORMATION CONTACT: To Possession, Use, and Transfer of Prevention (CDC), Department of Health request more information on the Select Agents and Toxins (OMB Control and Human Services (HHS). proposed project or to obtain a copy of No. 0920–0576, Expiration—11/30/ the information collection plan and ACTION: Notice with comment period. 2015)—Revision—Office of Public instruments, contact the Information Health Preparedness and Response SUMMARY: The Centers for Disease Collection Review Office, Centers for (OPHPR), Centers for Disease Control Control and Prevention (CDC), as part of Disease Control and Prevention, 1600 and Prevention (CDC). its continuing efforts to reduce public Clifton Road NE., MS–D74, Atlanta, burden and maximize the utility of Georgia 30329; phone: 404–639–7570; Background and Brief Description government information, invites the Email: omb@cdc.gov. Subtitle A of the Public Health general public and other Federal SUPPLEMENTARY INFORMATION: Under the Security and Bioterrorism Preparedness agencies to take this opportunity to Paperwork Reduction Act of 1995 (PRA) and Response Act of 2002, (42 U.S.C. comment on proposed and/or (44 U.S.C. 3501–3520), Federal agencies 262a), requires the United States continuing information collections, as must obtain approval from the Office of Department of Health and Human required by the Paperwork Reduction Management and Budget (OMB) for each Services (HHS) to regulate the Act of 1995. This notice invites collection of information they conduct possession, use, and transfer of comment on a proposed revision of the or sponsor. In addition, the PRA also biological agents or toxins that have the information collection entitled requires Federal agencies to provide a potential to pose a severe threat to Possession, Use, and Transfer of Select 60-day notice in the Federal Register public health and safety (select agents Agents and Toxins (OMB Control No. concerning each proposed collection of and toxins). Subtitle B of the Public 0920–0576). CDC is requesting Office of information, including each new Health Security and Bioterrorism Management and Budget (OMB) proposed collection, each proposed Preparedness and Response Act of 2002 approval to continue to collect extension of existing collection of (which may be cited as the Agricultural information under the select agent information, and each reinstatement of Bioterrorism Protection Act of 2002), (7 regulations through the use of five previously approved information U.S.C. 8401), requires the United States forms: (1) Application for Registration collection before submitting the Department of Agriculture (USDA) to for Possession. Use, and Transfer of collection to OMB for approval. To regulate the possession, use, and Select Agents and Toxins (APHIS/CDC comply with this requirement, we are transfer of biological agents or toxins asabaliauskas on DSK5VPTVN1PROD with NOTICES Form 1); (2) Request to Transfer Select publishing this notice of a proposed that have the potential to pose a severe Agents or Toxins (APHIS/CDC Form 2); data collection as described below. threat to animal or plant health, or (3) Incident Form to Report Potential Comments are invited on: (a) Whether animal or plant products (select agents Theft, Loss, Release, or Occupational the proposed collection of information and toxins). Accordingly, HHS and Exposure (APHIS/CDC Form 3); (4) is necessary for the proper performance USDA have promulgated regulations Report of Identification of Select Agent of the functions of the agency, including requiring individuals or entities that or Toxin from Clinical/Diagnostic whether the information shall have possess, use, or transfer select agents Specimen, Proficiency Testing, or practical utility; (b) the accuracy of the and toxins to register with the CDC or VerDate Sep<11>2014 17:49 Apr 02, 2015 Jkt 235001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\03APN1.SGM 03APN1

Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices 18243 the Animal and Plant Health Inspection Form 3); (4) Report of Identification of 4. An individual or entity may request Service (APHIS). See 42 CFR part 73, 7 Select Agent or Toxin from Clinical/ approval to perform a ‘‘restricted CFR part 331, and 9 CFR part 121 (the Diagnostic Specimen, Proficiency experiment’’ (42 CFR 73.13). select agent regulations). The Federal Testing, or Seizure by Federal Law 5. An individual or entity must Select Agent Program (FSAP) is the Enforcement (APHIS/CDC Form 4); and develop and implement a written collaboration of the CDC, Division of (5) Request for Exemption of Select security plan, biosafety plan, and Select Agents and Toxins (DSAT) and Agents and Toxins for an Investigational incident response plan (42 CFR 73.11(a), the APHIS Agriculture Select Agent Product (APHIS/CDC Form 5). 42 CFR 73.12(a), and 42 CFR 73.14(a)). Services (AgSAS) to administer the An entity may amend its registration select agent regulations in a manner to (42 CFR 73.7(h)(1)) if any changes occur 6. The Responsible Official at the to the information previously submitted must ensure a record of the training for minimize the administrative burden on to CDC. When applying for an each individual with access to select persons subject to the select agent amendment to a certificate of agents and toxins and each escorted regulations. The FSAP administers the registration, an entity would complete individual is maintained (42 CFR select agent regulations in close the relevant portion of the application 73.15(d)). coordination with the Federal Bureau of Investigation’s Criminal Justice package (APHIS/CDC Form 1). 7. An individual or entity may appeal Information Services (CJIS). Besides the forms listed above, there a denial, revocation, or suspension of Accordingly, CDC and APHIS have is no standard form for the following registration. (42 CFR 73.20(a)). adopted an identical system to collect information: 8. An individual may appeal a denial, information for the possession, use, and 1. An individual or entity may request limitation, or revocation of access transfer of select agents and toxins. an exclusion from the requirements of approval. (42 CFR 73.20(b)). the select agent regulations of an CDC is requesting OMB approval to attenuated strain of a select agent or a The total estimated annualized continue to collect information under select toxin modified to be less potent burden for all data collection was the select agent regulations through the or toxic. (42 CFR 73.3(e) and 73.4(e)). calculated using data obtained from the use of five forms: (1) Application for 2. Annual inspections that are FSAP database and is estimated as 8,528 Registration for Possession. Use, and conducted by the entity must be hours. Information will be collected via Transfer of Select Agents and Toxins documented. (42 CFR 73.9(a)(6)). fax, email and hard copy mail from (APHIS/CDC Form 1); (2) Request to 3. An individual’s security risk respondents. Upon OMB approval, CDC Transfer Select Agents or Toxins assessment may be expedited upon will begin use of the revised forms in (APHIS/CDC Form 2); (3) Incident Form written request by a Responsible Official November 2015 through November to Report Potential Theft, Loss, Release, and a showing of good cause. (42 CFR 2018. There is no cost to the or Occupational Exposure (APHIS/CDC 73.10(f)). respondents. ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Number of burden per Total burden Section Form name responses per respondents response hours respondent (in 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 asabaliauskas on DSK5VPTVN1PROD with NOTICES 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 VerDate Sep<11>2014 18:48 Apr 02, 2015 Jkt 235001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\03APN1.SGM 03APN1

18244 Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices DEPARTMENT OF HEALTH AND meaningfully advance drug The Director, Management Analysis HUMAN SERVICES development. and Services Office, has been delegated The current 60-day comment period the authority to sign Federal Register Food and Drug Administration does not allow sufficient time to obtain notices pertaining to announcements of the broad public response that will meetings and other committee [Docket No. FDA–2014–N–2187] inform FDA’s Biomarker Qualification management activities for both the Program going forward. FDA is Centers for Disease Control and Identifying Potential Biomarkers for extending the comment period for an Prevention and the Agency for Toxic Qualification and Describing Contexts additional 30 days, thus extending the Substances and Disease Registry. of Use To Address Areas Important to comment period to May 15, 2015. The Catherine Ramadei, Drug Development; Extension of Agency believes that a 30-day extension Comment Period allows adequate time for interested Acting Director, Management Analysis and Services Office, Centers for Disease Control persons to submit comments without and Prevention. AGENCY: Food and Drug Administration, significantly delaying progress on these HHS. important issues. [FR Doc. 2015–07639 Filed 4–2–15; 8:45 am] ACTION: Notice; extension of comment BILLING CODE 4163–18–P period. II. Request for Comments Interested persons may submit either SUMMARY: The Food and Drug electronic comments regarding this Administration (FDA) is extending the document to http://www.regulations.gov DEPARTMENT OF HOMELAND comment period for the notice entitled or written comments to the Division of SECURITY ‘‘Identifying Potential Biomarkers for Dockets Management (see ADDRESSES). It Qualification and Describing Contexts of United States Immigration and is only necessary to send one set of Use to Address Areas Important to Drug Customs Enforcement comments. Identify comments with the Development; Request for Comments’’ docket number found in brackets in the Agency Information Collection that appeared in the Federal Register of heading of this document. Received Activities: Extension, With Change, of February 13, 2015 (80 FR 8089). In the comments may be seen in the Division an Existing Information Collection; notice, FDA requested comments on of Dockets Management between 9 a.m. Comment Request identifying potential biomarkers for and 4 p.m., Monday through Friday, and qualification and describing contexts of will be posted to the docket at http:// ACTION: 60-Day Notice of Information use to address areas important to drug www.regulations.gov. collection for review; I–312/I–312A; development. The Agency is taking this Dated: March 30, 2015. Designation of Attorney in Fact/ action for an extension to allow Leslie Kux, Revocation of Attorney In Fact; OMB interested persons additional time to Associate Commissioner for Policy. Control No. 1653–0041. submit comments. [FR Doc. 2015–07631 Filed 4–2–15; 8:45 am] DATES: Submit either electronic or The Department of Homeland BILLING CODE 4164–01–P written comments by May 15, 2015 Security, U.S. Immigration and Customs ADDRESSES: Submit electronic Enforcement (ICE), is submitting the comments to http:// DEPARTMENT OF HEALTH AND following information collection request www.regulations.gov. Submit written HUMAN SERVICES for review and clearance in accordance comments to the Division of Dockets with the Paperwork Reduction Act of Management (HFA–305), Food and Drug Centers for Disease Control and 1995. The information collection is Administration, 5630 Fishers Lane, Rm. Prevention published in the Federal Register to 1061, Rockville, MD 20852. obtain comments from the public and FOR FURTHER INFORMATION CONTACT: Clinical Laboratory Improvement affected agencies. Comments are Marianne Noone, Center for Drug Advisory Committee encouraged and will be accepted for Evaluation and Research, Food and sixty days until June 2, 2015. Correction: This notice was published Drug Administration, 10903 New in the Federal Register on March 24, Written comments and suggestions Hampshire Ave., Bldg. 21, Rm. 4528, 2015, Volume 80, Number 56, Pages regarding items contained in this notice Silver Spring, MD 20993–0002, 301– 15621–15622. The times and dates and especially with regard to the 796–7495. should read as follows: estimated public burden and associated Times and Dates: 12:30 p.m.—5:00 response time should be directed to the SUPPLEMENTARY INFORMATION: p.m., April 15, 2015; 8:30 a.m.—12:00 Department of Homeland Security I. Background p.m., April 16, 2015. (DHS), Scott Elmore, Forms Management Office, U.S. Immigration In the Federal Register of February CONTACT PERSON FOR ADDITIONAL and Customs Enforcement, 801 I Street 13, 2015 (80 FR 8089), FDA published INFORMATION: Nancy Anderson, Chief, NW., Mailstop 5800, Washington, DC a notice with a 60-day comment period Laboratory Practice Standards Branch, 20536–5800. to request comments on identifying Division of Laboratory Programs, asabaliauskas on DSK5VPTVN1PROD with NOTICES potential biomarkers for qualification Standards, and Services, Center for Written comments and suggestions and describing contexts of use to Surveillance, Epidemiology and from the public and affected agencies address areas important to drug Laboratory Services, Office of Public concerning the proposed collection of development. FDA is encouraging Health Scientific Services, CDC, 1600 information should address one or more interested groups and individuals to Clifton Road NE., Mailstop F–11, of the following four points: submit information on specific medical Atlanta, Georgia 30329–4018; telephone (1) Evaluate whether the proposed and biological areas where novel (404) 498–2741; or via email at collection of information is necessary biomarkers can be identified that would NAnderson@cdc.gov for the proper performance of the VerDate Sep<11>2014 18:48 Apr 02, 2015 Jkt 235001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\03APN1.SGM 03APN1


Document Created: 2015-12-18 15:28:51
Document Modified: 2015-12-18 15:28:51
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice with comment period.
DatesWritten comments must be received on or before June 2, 2015.
ContactTo 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: [email protected]
FR Citation80 FR 18242 
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