80_FR_17821 80 FR 17758 - Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Investigational Uses

80 FR 17758 - Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Investigational Uses

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 63 (April 2, 2015)

Page Range17758-17760
FR Document2015-07539

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting and recordkeeping requirements for ``New Animal Drugs for Investigational Uses''.

Federal Register, Volume 80 Issue 63 (Thursday, April 2, 2015) 
[Federal Register Volume 80, Number 63 (Thursday, April 2, 2015)]
[Notices]
[Pages 17758-17760]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-07539]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0481]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; New Animal Drugs for Investigational Uses

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on

[[Page 17759]]

the reporting and recordkeeping requirements for ``New Animal Drugs for 
Investigational Uses''.

DATES: Submit either electronic or written comments on the collection 
of information by June 1, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the 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. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

New Animal Drugs for Investigational Uses--21 CFR Part 511 (OMB Control 
Number 0910-0117)--(Extension)

    FDA has the authority under the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) to approve new animal drugs. Section 512(j) of the 
Act (21 U.S.C. 360b(j)), authorizes FDA to issue regulations relating 
to the investigational use of new animal drugs. The regulations setting 
forth the conditions for investigational use of new animal drugs have 
been codified at 21 CFR part 511. If the new animal drug is only for 
tests in vitro or in laboratory research animals, the person 
distributing the new animal drug must maintain records showing the name 
and post office address of the expert or expert organization to whom it 
is shipped and the date, quantity, and batch or code mark of each 
shipment and delivery for a period of 2 years after such shipment or 
delivery. Before shipping a new animal drug for clinical investigations 
in animals, a sponsor must submit to FDA a Notice of Claimed 
Investigational Exemption (NCIE). The NCIE must contain, among other 
things, the following specific information: (1) Identity of the new 
animal drug, (2) labeling, (3) statement of compliance of any non-
clinical laboratory studies with good laboratory practices, (4) name 
and address of each clinical investigator, (5) the approximate number 
of animals to be treated or amount of new animal drug(s) to be shipped, 
and (6) information regarding the use of edible tissues from 
investigational animals. Part 511 also requires that records be 
established and maintained to document the distribution and use of the 
investigational new animal drug to assure that its use is safe and that 
the distribution is controlled to prevent potential abuse. The Agency 
uses these required records under its Bio-Research Monitoring Program 
to monitor the validity of the studies submitted to FDA to support new 
animal drug approval and to assure that proper use of the drug is 
maintained by the investigator.
    Investigational new animal drugs are used primarily by drug 
industry firms, academic institutions, and the government. 
Investigators may include individuals from these entities, as well as 
research firms and members of the medical professions. Respondents to 
this collection of information are the persons who use new animal drugs 
for investigational purposes.
    FDA estimates the burden of this information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR Section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
511.1(b)(4).....................             263            5.30           1,395               1           1,395
511.1(b)(5).....................             263             .26              69               8             552
511.1(b)(6).....................             263             .01               2               1               2
511.1(b)(8)(ii).................             263             .06              15               2              30
511.1(b)(9).....................             263             .06              15               8             120
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           2,099
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
         21 CFR Section              Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
511.1(a)(3).....................             263            2.07             545               1             545
511.1(b)(3).....................             263            5.30           1,395               1           1,395
511.1(b)(7)(ii).................             263            5.30           1,395             3.5         4,882.5

[[Page 17760]]

 
511.1(b)(8)(i)..................             263            5.30           1,395             3.5         4,882.5
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          11,705
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The estimate of the time required for reporting requirements, 
record preparation, and maintenance for this collection of information 
is based on informal Agency communication with industry. Based on the 
number of sponsors subject to animal drug user fees, FDA estimates that 
there are 263 respondents. We use this estimate consistently throughout 
the table and calculate the ``annual frequency per respondent'' by 
dividing the total annual responses by number of respondents. 
Additional information needed to make a final calculation of the total 
burden hours (i.e., the number of respondents, the number of 
recordkeepers, the number of NCIEs received, etc.) is derived from 
Agency records.

    Dated: March 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07539 Filed 4-1-15; 8:45 am]
BILLING CODE CODE 4164-01-P

17758 Federal Register / Vol. 80, No. 63 / Thursday, April 2, 2015 / Notices Biomedical Engineering Society (BMES) bench, and human models, and to confidential trade secrets or commercial is announcing a public conference accelerate and streamline the total property such as patentable material, entitled ‘‘Frontiers in Medical Devices: product life cycle of a medical device. and personal information concerning Innovations in Modeling and The use of computer models to simulate individuals associated with the grant Simulation’’. The purpose of this multiple use conditions and to visualize applications, the disclosure of which conference is to provide a forum to and display complex processes and data would constitute a clearly unwarranted discuss strategies to effectively utilize can revolutionize the way medical invasion of personal privacy. computational modeling and simulation outcomes and medical devices are Name of Committee: National Institute of in the development and evaluation of understood. Non-proprietary computer Mental Health Special Emphasis Panel; medical devices. models could benchmark device Mentoring Programs for HIV/AIDS Date and Time: The conference will performance, yet lack of access to Researchers 2. be held on May 18 through 20, 2015, biomedical data to construct the models Date: March 30, 2015. from 8 a.m. to 6 p.m. and rigorous methods to validate the Time: 11:00 a.m. to 1:00 p.m. Location: The public conference will models limit their credibility and use. Agenda: To review and evaluate grant be held at the Marriott Inn and To foster good science for M&S in the applications. Conference Center, University of Place: National Institutes of Health, medical device community, CDRH Neuroscience Center, 6001 Executive Maryland, 3501 University Blvd. East, needs to leverage the expertise in Hyattsville, MD 20783. Boulevard, Rockville, MD 20852, (Telephone industry and academia to advance M&S Conference Call). Contact Person: Donna R. Lochner, for regulatory uses. Contact Person: Aileen Schulte, Ph.D., Center for Devices and Radiological Scientific Review Officer, Division of Health, Food and Drug Administration, II. Topics for Discussion at the Public Extramural Activities, National Institute of 10903 New Hampshire Ave., Bldg. 62, Workshop Mental Health, NIH, Neuroscience Center, Rm. 3220, Silver Spring, MD 20993, A large number of issues will be 6001 Executive Blvd., Room 6140, MSC 9608, 301–796–6309, Donna.Lochner@ discussed at the conference with the Bethesda, MD 20892–9608, 301–443–1225, fda.hhs.gov. overall theme being the application of aschulte@mail.nih.gov Registration: To register for the public modeling and simulation for medical This notice is being published less than 15 conference please visit FDA’s Medical devices at different stages in the total days prior to the meeting due to the timing Devices News, Events, Workshops, and product life cycle. Topics include, but limitations imposed by the review and Conferences calendar at http:// funding cycle. are not limited to the following: www.bmes.org/meddevicesconference. • Model foundations for device (Catalogue of Federal Domestic Assistance There is a registration fee to attend the design ideation; Program No. 93.242, Mental Health Research public conference to cover the expenses, • concept development and design Grants, National Institutes of Health, HHS) and attendees must register in advance. optimization; Dated: March 27, 2015. The fees vary depending upon • modeling for robust design; Carolyn A. Baum, membership status in BMES, and • design verification and validation; Program Analyst, Office of Federal Advisory include BMES members ($450), non- • patient specific design; Committee Policy. BMES members (includes 1 year BMES • integration of modeling with [FR Doc. 2015–07507 Filed 4–1–15; 8:45 am] membership) ($600), and Government clinical studies; BILLING CODE CODE 4140–01–P rate (BMES memberships and meals are • modeling and device not included) ($250). Students will be commercialization. offered a discounted fee of $300 (BMES This public workshop may also form DEPARTMENT OF HEALTH AND member) or $350 (non-BMES member) the basis for future discussions related HUMAN SERVICES (includes 1 year BMES membership). A to computer modeling and simulation full listing of the registration fees can be that could benefit U.S. public health. Food and Drug Administration found on the Web site listed. Although Dated: March 27, 2015. the facilities are spacious, registration [Docket No. FDA–2011–N–0481] Leslie Kux, will be on a first-come, first-served Agency Information Collection basis. Associate Commissioner for Policy. [FR Doc. 2015–07551 Filed 4–1–15; 8:45 am] Activities; Proposed Collection; If you need special accommodations Comment Request; New Animal Drugs due to a disability, please contact Betse BILLING CODE CODE 4164–01–P for Investigational Uses Lyons at Betse@bmes.org or 301–459– 1999, 8201 Corporate Drive, Suite 1125, AGENCY: Food and Drug Administration, Landover, MD 20785–2224, FAX: 301– DEPARTMENT OF HEALTH AND HHS. 459–2444, no later than May 4, 2015. HUMAN SERVICES ACTION: Notice. To register for the public conference, please visit BMES Frontiers in Medical National Institutes of Health SUMMARY: The Food and Drug Devices registration page at http:// Administration (FDA) is announcing an National Institute Of Mental Health; bmes.org/meddevicesregistration. Those opportunity for public comment on the Notice of Closed Meeting without Internet access should contact proposed collection of certain Betse Lyons at 301–459–1999 to register. Pursuant to section 10(d) of the information by the Agency. Under the SUPPLEMENTARY INFORMATION: Federal Advisory Committee Act, as Paperwork Reduction Act of 1995 (the amended (5 U.S.C. App.), notice is PRA), Federal Agencies are required to I. Background tkelley on DSK3SPTVN1PROD with NOTICES hereby given of the following meeting. publish notice in the Federal Register The Center for Devices and The meeting will be closed to the concerning each proposed collection of Radiological Health (CDRH) believes public in accordance with the information, including each proposed that computer modeling and simulation provisions set forth in sections extension of an existing collection of (M&S) has the potential to substantially 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., information, and to allow 60 days for augment traditional models used to as amended. The grant applications and public comment in response to the evaluate medical devices; i.e., animal, the discussions could disclose notice. This notice solicits comments on VerDate Sep<11>2014 18:52 Apr 01, 2015 Jkt 235001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\02APN1.SGM 02APN1

Federal Register / Vol. 80, No. 63 / Thursday, April 2, 2015 / Notices 17759 the reporting and recordkeeping for approval. To comply with this shipped and the date, quantity, and requirements for ‘‘New Animal Drugs requirement, FDA is publishing notice batch or code mark of each shipment for Investigational Uses’’. of the proposed collection of and delivery for a period of 2 years after DATES: Submit either electronic or information set forth in this document. such shipment or delivery. Before written comments on the collection of With respect to the following shipping a new animal drug for clinical information by June 1, 2015. collection of information, FDA invites investigations in animals, a sponsor ADDRESSES: Submit electronic comments on these topics: (1) Whether must submit to FDA a Notice of Claimed comments on the collection of the proposed collection of information Investigational Exemption (NCIE). The information to: http:// is necessary for the proper performance NCIE must contain, among other things, www.regulations.gov. Submit written of FDA’s functions, including whether the following specific information: (1) comments on the collection of the information will have practical Identity of the new animal drug, (2) information to the Division of Dockets utility; (2) the accuracy of FDA’s labeling, (3) statement of compliance of Management (HFA–305), Food and Drug estimate of the burden of the proposed any non-clinical laboratory studies with Administration, 5630 Fishers Lane, Rm. collection of information, including the good laboratory practices, (4) name and 1061, Rockville, MD 20852. All validity of the methodology and address of each clinical investigator, (5) comments should be identified with the assumptions used; (3) ways to enhance the approximate number of animals to docket number found in brackets in the the quality, utility, and clarity of the be treated or amount of new animal heading of this document. information to be collected; and (4) drug(s) to be shipped, and (6) ways to minimize the burden of the information regarding the use of edible FOR FURTHER INFORMATION CONTACT: FDA collection of information on tissues from investigational animals. PRA Staff, Office of Operations, Food respondents, including through the use Part 511 also requires that records be and Drug Administration, 8455 of automated collection techniques, established and maintained to Colesville Rd., COLE–14526, Silver when appropriate, and other forms of document the distribution and use of Spring, MD 20993–0002, PRAStaff@ information technology. the investigational new animal drug to fda.hhs.gov. assure that its use is safe and that the New Animal Drugs for Investigational distribution is controlled to prevent SUPPLEMENTARY INFORMATION: Under the Uses—21 CFR Part 511 (OMB Control potential abuse. The Agency uses these PRA (44 U.S.C. 3501–3520), Federal Number 0910–0117)—(Extension) required records under its Bio-Research Agencies must obtain approval from the Office of Management and Budget FDA has the authority under the Monitoring Program to monitor the (OMB) for each collection of Federal Food, Drug, and Cosmetic Act validity of the studies submitted to FDA information they conduct or sponsor. (the FD&C Act) to approve new animal to support new animal drug approval ‘‘Collection of information’’ is defined drugs. Section 512(j) of the Act (21 and to assure that proper use of the drug in 44 U.S.C. 3502(3) and 5 CFR U.S.C. 360b(j)), authorizes FDA to issue is maintained by the investigator. 1320.3(c) and includes Agency requests regulations relating to the Investigational new animal drugs are or requirements that members of the investigational use of new animal drugs. used primarily by drug industry firms, public submit reports, keep records, or The regulations setting forth the academic institutions, and the provide information to a third party. conditions for investigational use of government. Investigators may include Section 3506(c)(2)(A) of the PRA (44 new animal drugs have been codified at individuals from these entities, as well U.S.C. 3506(c)(2)(A)) requires Federal 21 CFR part 511. If the new animal drug as research firms and members of the Agencies to provide a 60-day notice in is only for tests in vitro or in laboratory medical professions. Respondents to the Federal Register concerning each research animals, the person this collection of information are the proposed collection of information, distributing the new animal drug must persons who use new animal drugs for including each proposed extension of an maintain records showing the name and investigational purposes. existing collection of information, post office address of the expert or FDA estimates the burden of this before submitting the collection to OMB expert organization to whom it is information collection as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of re- Average bur- Number of Total annual 21 CFR Section sponses per den per re- Total hours respondents responses respondent sponse 511.1(b)(4) ........................................................................... 263 5.30 1,395 1 1,395 511.1(b)(5) ........................................................................... 263 .26 69 8 552 511.1(b)(6) ........................................................................... 263 .01 2 1 2 511.1(b)(8)(ii) ....................................................................... 263 .06 15 2 30 511.1(b)(9) ........................................................................... 263 .06 15 8 120 Total .............................................................................. ........................ ........................ ........................ ........................ 2,099 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 tkelley on DSK3SPTVN1PROD with NOTICES Number of Average bur- Number of Total annual 21 CFR Section records per den per rec- Total hours recordkeepers records recordkeeper ordkeeping 511.1(a)(3) ........................................................................... 263 2.07 545 1 545 511.1(b)(3) ........................................................................... 263 5.30 1,395 1 1,395 511.1(b)(7)(ii) ....................................................................... 263 5.30 1,395 3.5 4,882.5 VerDate Sep<11>2014 18:52 Apr 01, 2015 Jkt 235001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\02APN1.SGM 02APN1

17760 Federal Register / Vol. 80, No. 63 / Thursday, April 2, 2015 / Notices TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued Number of Average bur- Number of Total annual 21 CFR Section records per den per rec- Total hours recordkeepers records recordkeeper ordkeeping 511.1(b)(8)(i) ........................................................................ 263 5.30 1,395 3.5 4,882.5 Total .............................................................................. ........................ ........................ ........................ ........................ 11,705 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The estimate of the time required for the authority to sign Federal Register Prevention and the Agency for Toxic reporting requirements, record notices pertaining to announcements of Substances and Disease Registry. preparation, and maintenance for this meetings and other committee Elaine L. Baker, collection of information is based on management activities, for both the informal Agency communication with Director, Management Analysis and Services Centers for Disease Control and Office, Centers for Disease Control and industry. Based on the number of Prevention and the Agency for Toxic Prevention. sponsors subject to animal drug user Substances and Disease Registry. [FR Doc. 2015–07544 Filed 4–1–15; 8:45 am] fees, FDA estimates that there are 263 Elaine L. Baker, BILLING CODE 4163–18–P respondents. We use this estimate consistently throughout the table and Director, Management Analysis and Services calculate the ‘‘annual frequency per Office, Centers for Disease Control and DEPARTMENT OF HEALTH AND respondent’’ by dividing the total Prevention. HUMAN SERVICES annual responses by number of [FR Doc. 2015–07545 Filed 4–1–15; 8:45 am] respondents. Additional information BILLING CODE CODE 4163–18–P Health Resources and Services needed to make a final calculation of the Administration total burden hours (i.e., the number of respondents, the number of DEPARTMENT OF HEALTH AND Agency Information Collection recordkeepers, the number of NCIEs HUMAN SERVICES Activities: Proposed Collection: Public received, etc.) is derived from Agency Comment Request records. Centers for Disease Control and AGENCY: Health Resources and Services Dated: March 27, 2015. Prevention Administration, HHS. Leslie Kux, ACTION: Notice. Disease, Disability, and Injury Associate Commissioner for Policy. Prevention and Control Special SUMMARY: In compliance with the [FR Doc. 2015–07539 Filed 4–1–15; 8:45 am] Emphasis Panel (SEP): Initial Review requirement for opportunity for public BILLING CODE CODE 4164–01–P comment on proposed data collection The meeting announced below projects (Section 3506(c)(2)(A) of the concerns Using Longitudinal Data to Paperwork Reduction Act of 1995), the DEPARTMENT OF HEALTH AND Characterize the Natural History of Health Resources and Services HUMAN SERVICES Fragile X Syndrome to Improve Services Administration (HRSA) announces Centers for Disease Control and and Outcomes, DD15–003, initial plans to submit an Information Prevention review. Collection Request (ICR), described SUMMARY: This document corrects a below, to the Office of Management and Disease, Disability, and Injury notice that was published in the Federal Budget (OMB). Prior to submitting the Prevention and Control Special Register on March 25, 2015 Volume 80, ICR to OMB, HRSA seeks comments Emphasis Panel (SEP): Initial Review Number 57, page 15798. The time and from the public regarding the burden The meeting announced below date should read as follows: estimate, below, or any other aspect of concerns Evaluation of a Stepped Care the ICR. Time and Date: 11:00 a.m.–6:00 p.m., Approach for Perinatal Depression DATES: Comments on this Information April 15, 2015 (Closed). Treatment in Obstetrics and Gynecology Collection Request must be received no Clinics, DP15–005, initial review. FOR FURTHER INFORMATION CONTACT: M. later than June 1, 2015. SUMMARY: This document corrects a Chris Langub, Ph.D., Scientific Review ADDRESSES: Submit your comments to notice that was published in the Federal Officer, CDC, 4770 Buford Highway NE., paperwork@hrsa.gov or mail the HRSA Register on March 12, 2015 Volume 80, Mailstop F46, Atlanta, Georgia 30341, Information Collection Clearance Number 48, page 13012. The time and Telephone: (770) 488–3585, EEO6@ Officer, Room 10C–03, Parklawn date should read as follows: cdc.gov. Building, 5600 Fishers Lane, Rockville, Time and Date: 11:00 a.m.–6:00 p.m., The Director, Management Analysis MD 20857. April 1, 2015 (Closed). and Services Office, has been delegated FOR FURTHER INFORMATION CONTACT: To FOR FURTHER INFORMATION CONTACT: the authority to sign Federal Register request more information on the tkelley on DSK3SPTVN1PROD with NOTICES M. Chris Langub, Ph.D., Scientific notices pertaining to announcements of proposed project or to obtain a copy of Review Officer, CDC, 4770 Buford meetings and other committee the data collection plans and draft Highway NE., Mailstop F46, Atlanta, management activities, for both the instruments, email paperwork@hrsa.gov Georgia 30341, Telephone: (770) 488– or call the HRSA Information Collection Centers for Disease Control and 3585, EEO6@cdc.gov. Clearance Officer at (301) 443–1984. The Director, Management Analysis SUPPLEMENTARY INFORMATION: When and Services Office, has been delegated submitting comments or requesting VerDate Sep<11>2014 18:52 Apr 01, 2015 Jkt 235001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\02APN1.SGM 02APN1


Document Created: 2018-02-21 10:03:34
Document Modified: 2018-02-21 10:03:34
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.
DatesSubmit either electronic or written comments on the collection of information by June 1, 2015.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation80 FR 17758 
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